Multiple Myeloma
Conditions
Keywords
GSK2857916, Pembrolizumab, Multiple Myeloma, RP2D
Brief summary
This is a phase I/II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects with RRMM. This study will enroll adult subjects with RRMM, who have undergone stem cell transplant or who are considered transplant ineligible. Part 1 is a dose escalation phase to evaluate the safety and tolerability of escalating doses of GSK2857916 in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of GSK2857916 are planned to be studied: 2.5 milligrams per kilograms (mg/kg) (dose level \[DL\] 1) and 3.4 mg/kg (DL2). Part 2 is a dose expansion cohort. Once the RP2D has been identified, an expansion cohort will open for enrolment to confirm the safety profile and to evaluate the clinical activity of the combination. Up to 40 evaluable subjects will be enrolled in this two-part study (up to 12 in Part 1, and 28 in Part 2).
Interventions
belantamab mafodotin will be available as 20 milligrams per millilitre (mg/mL) solution for IV infusion, supplied as frozen liquid. belantamab mafodotin solution will be diluted in normal 0.9% saline to the appropriate concentration for the dose.
Pembrolizumab will be available as 100 mg/4 mL solution that should be stored under refrigeration at 2-8 degree Celsius. Pembrolizumab injection (solution) will be diluted prior to IV administration in 0.9% sodium chloride injection or 5% dextrose injection.
Sponsors
Study design
Masking description
This will be an open-label study. Hence, there will be no masking.
Intervention model description
Subjects will receive GSK2857916 at escalating doses along with pembrolizumab on Day 1 of each 21-day Cycle to establish RP2D during the Part 1 of the study. Subjects will receive GSK2857916 at RP2D along with pembrolizumab on Day 1 of each 21-day Cycle in Part 2 of the study.
Eligibility
Inclusion criteria
* Provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * Male or female, 18 years or older (at the time consent is obtained). * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subjects must: have histologically or cytologically confirmed diagnosis of Multiple myeloma (MM), as defined by IMWG, 2014 and has undergone stem cell transplant or is considered transplant ineligible, and has been treated with at least 3 prior lines of prior anti-myeloma treatments including an immunomodulatory imide drug (IMiD) (eg. lenalidomide or pomalidomide), a proteasome inhibitor (eg. bortezomib, ixazomib or carfilzomib) and an anti-CD38 antibody alone or in combination. Line of therapy are defined by consensus panel of the International Myeloma Workshop, Has measurable disease defined as one the following: a) Serum M-protein \>=0.5 grams per deciliter (g/dL) (\>=5 grams per liter \[g/L\]). b) Urine M-protein ≥200 mg/24h. c) Serum Free light chain (FLC) assay: Involved FLC level ≥10 milligrams per deciliter (mg/dL) (≥100 milligrams per liter \[mg/L\]) and an abnormal serum free light chain ratio (\<0.26 or \>1.65). * Subjects with a history of autologous stem cell transplant are eligible for study participation provided the following eligibility criteria are met: a) transplant was \> 100 days prior to study enrolment. b) no active infection(s). c) subject meets the remainder of the eligibility criteria. * Adequate organ system functions as defined by the laboratory assessments. * All prior treatment-related toxicities (defined by National Cancer Institute-Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], version 4.03, 2010) must be \<= Grade 1 at the time of enrolment except for alopecia and Grade 2 neuropathy. * A female subject is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency, during the intervention period and for at least 120 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. A WOCBP must have a negative highly sensitive serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. * Male subjects are eligible to participate if they agree to the following during the intervention period and for at least 140 days after the last dose of study intervention. Male subjects should refrain from donating sperm, plus, either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR Must agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
Exclusion criteria
A subject will NOT be eligible for inclusion in this study if any of the following criteria apply: * Systemic anti-myeloma therapy or an investigational drug \<=14 days or five half-lives, whichever is shorter, preceding the first dose of study drug * Plasmapheresis within 7 days prior to the first dose of study drug * Prior treatment with a monoclonal antibody within 30 days of receiving the first dose of study drugs * Has received prior therapy with an anti-PD-1, anti-Programmed cell death Ligand 1 (PD-L1), or anti-Programmed cell death Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen 4 \[CTLA-4\], OX 40, CD137) and was discontinued from that treatment due to a Grade 3 or higher immune related adverse event (irAE) * Current corneal epithelial disease except mild punctate keratopathy * Any major surgery within the last four weeks prior to the first dose of study therapy * Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect subject's safety). Subjects with isolated proteinuria resulting from MM are eligible, provided they fulfil criteria as per adequate organ system function mentioned under inclusion criteria. * Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures. * Has received prior radiotherapy within 2 weeks of start of study therapy. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (\<=2 weeks of radiotherapy) to non-central nervous system (CNS) disease. * History of (non-infectious) pneumonitis that required steroids, or current pneumonitis * Current active liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. * Malignancies other than disease under study are excluded, except for any other malignancy from which the subject has been disease-free for more than 2 years and, in the opinion of the principal investigators and GSK Medical Monitor, will not affect the evaluation of the effects of this clinical trial treatment on the currently targeted malignancy (RRMM). Subjects with curatively treated non-melanoma skin cancer are allowed. * Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study therapy * Evidence of cardiovascular risk including any of the following: a) corrected for heart rate by Fridericia's formula (QTcF) interval ≥470 msecs. b) Evidence of current clinically significant uncontrolled arrhythmias; i. including clinically significant ECG abnormalities including 2nd degree (Type II) or 3rd degree atrioventricular (AV) block. c) History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within six months of Screening. d) Class III or IV heart failure as defined by the New York Heart Association functional classification system. e) Uncontrolled hypertension. f) Presence of cardiac pacemaker (or defibrillator) with a predominantly ventricular paced rhythm, limiting ECG/QTcF analysis. g) Abnormal cardiac valve morphology (\>=Grade 2) documented by echocardiogram (subjects with grade 1 abnormalities \[i.e., mild regurgitation/stenosis\] can be entered on study). Subjects with moderate valvular thickening should not be entered on study. * Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2857916 or pembrolizumab, or any of the components of the study treatment. * Pregnant or lactating female. * Known active infection requiring antibiotic, antiviral, or antifungal treatment. * Known Human Immunodeficiency Virus (HIV) infection. * Presence of hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study treatment * Positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment. * Has received a live-virus vaccination within 30 days of planned start of study therapy. * Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other chronic form of immunosuppressive therapy within 7 days prior the first dose of study therapy. * Has known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study. * Has had an allogenic tissue/solid organ transplant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to approximately 31 months | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. |
| Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs) | Up to 21 days | DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: any Grade 4 and 3 non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value, hematologic toxicity lasting \>=7 days, except Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia associated with clinically significant bleeding. Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Nephrotoxicity requiring dialysis, Liver toxicity, prolonged delay (\>14 days) in initiating Cycle 2 due to any treatment (pembrolizumab or GSK2857916) related toxicity, any treatment-related toxicity that causes discontinuation of treatment during Cycle 1, any other toxicity considered to be dose-limiting that occurs beyond 21 days and any other event which in the judgment of the investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT. |
| Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 31 months | Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cells (WBC) count, lymphocytes, neutrophils and platelet count. The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented. |
| Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 31 months | Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. |
| Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Baseline (Day 1) and up to approximately 31 months | Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate, potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented. |
| Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Baseline (Day 1) and up to 31 months | Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. |
| Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Baseline (Day 1) and up to approximately 31 months | Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline urinalysis results is presented. |
| Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH) | Baseline (Day 1) and Week 46 | Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 1 - Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and Week 46 | Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | Baseline (Day 1) and up to approximately 31 months | DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented. |
| Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Baseline (Day 1) and up to approximately 31 months | Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High. |
| Part 2 - Percentage of Participants With Overall Response Rate (ORR) | Up to approximately 31 months | ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score | Up to approximately 178 weeks | The time for the onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) was calculated. |
| Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score | Up to approximately 178 weeks | The onset of any visual acuity event (change from baseline in logMAR score \>= 0.3 in either eye) was considered resolved if the change from baseline in logMAR score was less than 0.3 in both eyes. Participants with resolved and not resolved outcome of the worsening eye were presented. |
| Part 2 - Duration of First Occurrence of Worsening in BCVA Score | Up to approximately 178 weeks | The time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event is resolved (change from baseline logMAR score \< 0.3 in both eyes) was used to calculate the duration of first occurrence. |
| Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision | Up to approximately 178 weeks | A definite worsened vision was defined as a change from baseline \>=0.3 logMAR score. |
| Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score | Up to approximately 178 weeks | The event was considered resolved if the change from baseline in logMAR score \< 0.3 in both eyes. |
| Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score | Up to approximately 178 weeks | The time taken for the resolution of worsening eye post treatment exposure. Duration was defined as the time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event was considered resolved (change from baseline logMAR score \< 0.3 in both eyes). It required at least a one day gap between the resolution of all events from first occurrence to the onset of second occurrence. The end of treatment exposure was defined as 20 days from last infusion date. |
| Part 2 - Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception | Baseline (Day 1) and up to approximately 178 weeks | — |
| Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Baseline (Day 1) and up to approximately 178 weeks | Participants with worst-case shift from baseline in corneal epithelium defects by right eye, left eye and worse eye are presented as normal (N), abnormal (AN) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Baseline (Day 1) and up to approximately 178 weeks | Participants with worst-case shift from baseline in corneal examination: corneal ulcer, epithelial microcystic edema, subepithelial haze, corneal neovascularization and microcysts without edema, by right eye (R), left eye (L) and worse eye (W) are presented as yes (Y), no (N) and missing (M). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Baseline (Day 1) and up to approximately 178 weeks | Participants with worse case punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Baseline (Day 1) and up to approximately 178 weeks | Participants with worst-case shift from baseline in corneal examination which included: clear, pseudophakia, nuclear sclerosis, cortical cataract and posterior subcapsular cataract by right eye, left eye and worse eye are presented as yes (Y), no (N) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 2 - Percentage of Participants With Clinical Benefit Rate | Up to approximately 178 weeks | Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%. |
| Part 2 - Duration of Response | Up to approximately 178 weeks | Duration of response was defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \<200 mg/24 h. |
| Part 2 - Time to Response | Up to approximately 178 weeks | Time to response (TTR) was defined as the time between the date of first dose and the first documented evidence of response (PR or better) among participants who achieved a confirmed response of PR or better. |
| Part 2 - Time to Best Response | Up to approximately 178 weeks | Time to best response was defined as the time between the date of first dose and the first best documented response (PR or better) among participants who achieved a confirmed response of PR or better. |
| Part 2 - Progression-free Survival | Up to approximately 178 weeks | Progression-free survival was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). |
| Part 2 - Time to Disease Progression | Up to approximately 178 weeks | Time to disease progression was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to PD. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). |
| Part 2 - Overall Survival | Up to approximately 178 weeks | Overall Survival was defined as the time from first dose until death due to any cause. |
| Part 1 - Maximum Concentration (Cmax) for Belantamab Mafodotin After First Dose | Pre-dose, end of infusion (EOI), 2, 4, 9, and 24 h post-SOI (start of infusion) on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for Pharmacokinetic (PK) analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Cmax for Belantamab Mafodotin After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - End of Infusion Concentration (C-EOI) for Belantamab Mafodotin | EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - C-EOI for Belantamab Mafodotin | EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Time of Cmax (Tmax) for Belantamab Mafodotin After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Tmax for Belantamab Mafodotin After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin | Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Ctrough for Belantamab Mafodotin | Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Belantamab Mafodotin After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Tlast for Belantamab Mafodotin After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Belantamab Mafodotin After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - AUC (0-tau) for Belantamab Mafodotin After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Cmax for Total mAb After First Dose | Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - C-EOI for Total mAb | EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, Cycle 5, Cycle 8, and Cycle 11 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - C-EOI for Total mAb | EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, and Cycle 5 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Tmax for Total mAb After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Tmax for Total mAb After First Dose | Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Ctrough for Total mAb | Cycle 1, Cycle 4, Cycle 7, Cycle 10, and Cycle 13 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Ctrough for Total mAb | Cycle 1 and Cycle 4 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups. |
| Part 2 - Tlast for Total mAb After First Dose | Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups. |
| Part 1 - AUC (0-tau) for Total mAb After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Percentage of Participants With Overall Response Rate (ORR) | Up to approximately 178 weeks | ORR was defined as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR), according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h. |
| Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Cmax for Cys-mcMMAF After First Dose | Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - C-EOI for Cys-mcMMAF After First Dose | EOI post belantamab mafodotin dose on Day 1 of Cycle 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - C-EOI for Cys-mcMMAF After First Dose | EOI post belantamab mafodotin dose on Day 1 of Cycle 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Tmax for Cys-mcMMAF After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups. |
| Part 2 - Tmax for Cys-mcMMAF After First Dose | Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups. |
| Part 1 - Tlast for Cys-mcMMAF After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups. |
| Part 2 - Tlast for Cys-mcMMAF After First Dose | Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups. |
| Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose | Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Cmax for Pembrolizumab After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Cmax for Pembrolizumab After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Tmax for Pembrolizumab After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Tmax for Pembrolizumab After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - AUC (0-tau) for Pembrolizumab After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - AUC (0-tau) for Pembrolizumab After First Dose | Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Baseline (Day 1) and until end of treatment (up to 178 weeks) | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin | Baseline (Day 1) and until end of treatment (up to 178 weeks) | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 1 - Titers of ADAs Against Belantamab Mafodotin | Up to approximately 178 weeks | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. |
| Part 2 - Titers of ADAs Against Belantamab Mafodotin | Baseline (Day 1) and up to approximately 178 weeks | Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers. |
| Part 2 - AUC (0-tau) for Total mAb After First Dose | Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1 | Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. |
| Part 2 - Number of Participants With AEs and SAEs | Up to approximately 178 weeks | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function. |
| Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 178 weeks | Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cell (WBC) count, lymphocytes, neutrophils and platelet. The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented. |
| Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Baseline (Day 1) and up to approximately 178 weeks | Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), Erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. |
| Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Baseline (Day 1) and up to approximately 178 weeks | Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented. |
| Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Baseline (Day 1) and up to approximately 178 weeks | Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes from baseline, and increases to high values have been presented. |
| Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Baseline (Day 1) and up to approximately 178 weeks | Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for uranalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline are presented. |
| Part 2 - Changes From Baseline in Urine Specific Gravity | Baseline (Day 1) and until end of treatment (up to 178 weeks) | Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date |
| Part 2 - Changes From Baseline in Urine pH | Baseline (Day 1) and until end of treatment (up to 178 weeks) | Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP | Baseline (Day 1) and up to approximately 178 weeks | DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Data for worst-case post Baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented. |
| Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Baseline (Day 1) and up to approximately 178 weeks | Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores | Baseline (Day 1) and up to approximately 178 weeks | BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any maximum worst-case change from baseline categories are presented for right and left eyes. No change/improved vision is defined as a change from baseline \<0.12; a possible worsened vision is defined as a change from baseline \>=0.12 to \<0.3; a definite worsened vision is defined as a change from baseline \>=0.3 logMAR score. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
Countries
Canada, Germany, Spain, United States
Participant flow
Recruitment details
The study consisted of two phases - Main Study Phase and Post Analysis Continued Treatment (PACT) Phase. In PACT phase those participants still benefiting from drug continued to receive study drug until discontinued or withdrawn from study.
Pre-assignment details
Total of 41 participants were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles. | 6 |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation Participants were administered with 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles. | 7 |
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles. | 28 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Main Study Phase (Day 1 to Week 178) | Lost to Follow-up | 0 | 1 | 0 | 0 |
| Main Study Phase (Day 1 to Week 178) | Physician Decision | 0 | 0 | 1 | 0 |
| Main Study Phase (Day 1 to Week 178) | Withdrawal by Subject | 3 | 2 | 8 | 0 |
| PACT Phase (Week 178 to Week 221) | Withdrawal by Subject | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | Total |
|---|---|---|---|---|
| Age, Continuous | 66.8 YEARS STANDARD_DEVIATION 12.09 | 67.7 YEARS STANDARD_DEVIATION 9.21 | 61.5 YEARS STANDARD_DEVIATION 9.41 | 63.3 YEARS STANDARD_DEVIATION 9.92 |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black OR African American | 1 Participants | 2 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 5 Participants | 5 Participants | 23 Participants | 33 Participants |
| Sex: Female, Male Female | 5 Participants | 4 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 18 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 6 | 3 / 7 | 7 / 28 | 0 / 2 |
| other Total, other adverse events | 6 / 6 | 6 / 7 | 27 / 28 | 0 / 2 |
| serious Total, serious adverse events | 4 / 6 | 5 / 7 | 5 / 28 | 0 / 2 |
Outcome results
Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH)
Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and Week 46
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH) | 1.0 Potential of Hydrogen (pH) | Standard Deviation 2.83 |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Changes From Baseline in Urine Potential of Hydrogen (pH) | 0.0 Potential of Hydrogen (pH) | — |
Part 1 - Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and Week 46
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Changes From Baseline in Urine Specific Gravity | -0.0010 Ratio | Standard Deviation 0.00566 |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Changes From Baseline in Urine Specific Gravity | 0.0100 Ratio | — |
Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.
Time frame: Up to approximately 31 months
Population: All Treated Population included all participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 5 Participants |
Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs)
DLT is an AE that is considered by the investigator to be clinically relevant and attributed to the study therapy during the 21 day DLT period and meets at least one of the DLT criteria: any Grade 4 and 3 non-hematologic toxicity, any Grade 3 or greater non-hematologic laboratory value, hematologic toxicity lasting \>=7 days, except Grade 4 thrombocytopenia of any duration or Grade 3 thrombocytopenia associated with clinically significant bleeding. Grade 3 or greater febrile neutropenia lasting \>48 hours (h) despite adequate treatment, Nephrotoxicity requiring dialysis, Liver toxicity, prolonged delay (\>14 days) in initiating Cycle 2 due to any treatment (pembrolizumab or GSK2857916) related toxicity, any treatment-related toxicity that causes discontinuation of treatment during Cycle 1, any other toxicity considered to be dose-limiting that occurs beyond 21 days and any other event which in the judgment of the investigator and GlaxoSmithKline Medical Monitor is considered to be a DLT.
Time frame: Up to 21 days
Population: All Treated Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Dose Limiting Toxicities (DLTs) | 0 Participants |
Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst case change from baseline was presented as Baseline to low, Baseline to Normal or No change and Baseline to High.
Time frame: Baseline (Day 1) and up to approximately 31 months
Population: All Treated Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Pulse Rate | Baseline To Low | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Pulse Rate | Baseline To Normal or No Change | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Pulse Rate | Baseline To High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Temperature | Baseline To Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Temperature | Baseline To Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Temperature | Baseline To High | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Temperature | Baseline To Normal or No Change | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Pulse Rate | Baseline To Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Temperature | Baseline To Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Pulse Rate | Baseline To Normal or No Change | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Temperature | Baseline To High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Pulse Rate | Baseline To High | 2 Participants |
Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Change to Normal or No Change | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Change to Normal or No Change | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Change to Normal or No Change | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocyte, Increase to High | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Change to Normal or No Change | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Change to Normal or No Change | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocyte, Change to Normal or No Change | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Change to Normal or No Change | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Increase to High | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocyte, Decrease to Low | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Change to Normal or No Change | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocyte, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocyte, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocyte, Increase to High | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Change to Normal or No Change | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Change to Normal or No Change | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Increase to High | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Change to Normal or No Change | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Change to Normal or No Change | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Change to Normal or No Change | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Change to Normal or No Change | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Increase to High | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Increase to High | 1 Participants |
Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters
Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to 31 months
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Calcium, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Carbon dioxide, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Direct bilirubin, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Direct bilirubin, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T4, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T3, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Calcium, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Calcium, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Carbon dioxide, Change to Normal or No Change | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Carbon dioxide, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Chloride, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Chloride, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Chloride, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Direct bilirubin, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Protein, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Protein, Change to Normal or No Change | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Protein, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | TSH, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | TSH, Change to Normal or No Change | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | TSH, Increase to High | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T4, Change to Normal or No Change | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T4, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T3, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T3, Change to Normal or No Change | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | TSH, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Chloride, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Carbon dioxide, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Direct bilirubin, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T3, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Direct bilirubin, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Direct bilirubin, Change to Normal or No Change | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T4, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T4, Change to Normal or No Change | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T3, Change to Normal or No Change | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | TSH, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Protein, Decrease to Low | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Calcium, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Calcium, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T4, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Calcium, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Carbon dioxide, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Protein, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Carbon dioxide, Change to Normal or No Change | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | TSH, Increase to High | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Protein, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Chloride, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T3, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Chloride, Change to Normal or No Change | 4 Participants |
Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for urinalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline urinalysis results is presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Population: All Treated Population. Only those participants with data available for worst-case post baseline have been presented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Glucose, Any Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Occult Blood, No Change/Decreased | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Glucose, No Change/Decreased | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Ketones, No Change/Decreased | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Ketones, Any Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Occult Blood, Any Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Protein, No Change/Decreased | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Protein, Any Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Protein, Any Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Ketones, Any Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Occult Blood, No Change/Decreased | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Protein, No Change/Decreased | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Glucose, No Change/Decreased | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Glucose, Any Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Occult Blood, Any Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Ketones, No Change/Decreased | 5 Participants |
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cells (WBC) count, lymphocytes, neutrophils and platelet count. The laboratory parameters were graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst-case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Decreased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Decreased (Anemia), Increase to Grade 3 | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Decreased, Any Grade Increase | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Increased (Leukocytosis), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Decreased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Increased, Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Decreased, Increase to Grade 4 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Increased (Leukocytosis), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Increased, Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Decreased (Anemia), Any Grade Increase | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophil Decreased, Any Grade Increase | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Increased (Leukocytosis), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophil Decreased, Increase to Grade 3 | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophil Decreased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelet Decreased, Any Grade Increase | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Decreased, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelet Decreased, Increase to Grade 3 | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Decreased (Anemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelet Decreased, Increase to Grade 4 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Decreased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelet Decreased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophil Decreased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Decreased (Anemia), Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Decreased (Anemia), Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Decreased (Anemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Increased, Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Increased (Leukocytosis), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Increased (Leukocytosis), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Increased (Leukocytosis), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Decreased, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Decreased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC Decreased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Decreased, Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Decreased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Decreased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Increased, Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophil Decreased, Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophil Decreased, Increase to Grade 4 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelet Decreased, Any Grade Increase | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelet Decreased, Increase to Grade 3 | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte Increased, Increase to Grade 3 | 0 Participants |
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate, potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Blood bilirubin Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Decreased (Hypoglycemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Increased (Hypercalcemia), Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Increased (Hypercalcemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Decreased (Hypoglycemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Increased (Hypercalcemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Decreased (Hypomagnesemia), Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Decreased (Hypocalcemia), Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Decreased (Hypocalcemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | ALT Increased, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | CPK Increased, Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Decreased (Hypocalcemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | ALT Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | CPK Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Increased (Hyperkalemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Creatinine Increased, Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | ALT Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Creatinine Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | CPK Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Creatinine Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Albumin Decreased (Hypoalbuminemia), Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | GGT Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Albumin Decreased (Hypoalbuminemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | GGT Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Albumin Decreased (Hypoalbuminemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Increased (Hypernatremia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Alkaline phosphatase Increased, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Increased (Hypermagnesemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Decreased (Hyponatremia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Decreased (Hypomagnesemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Decreased (Hypomagnesemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Alkaline phosphatase Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Phosphate Decreased (Hypophosphatemia), Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Increased (Hyperglycemia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Phosphate Decreased (Hypophosphatemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Alkaline phosphatase Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Phosphate Decreased (Hypophosphatemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | GGT Increased, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Increased (Hyperkalemia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | AST Increased, Any Grade Increase | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Increased (Hyperkalemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Increased (Hyperglycemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Decreased (Hypokalemia), Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | AST Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Decreased (Hypokalemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Increased (Hypermagnesemia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Decreased (Hypokalemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Increased (Hypernatremia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | AST Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Blood bilirubin Increased, Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Increased (Hypernatremia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Decreased (Hypoglycemia), Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Decreased (Hyponatremia), Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Blood bilirubin Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Increased (Hypermagnesemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Decreased (Hyponatremia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Increased (Hyperglycemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Decreased (Hyponatremia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Increased (Hyperglycemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Albumin Decreased (Hypoalbuminemia), Any Grade Increase | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | AST Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Decreased (Hypocalcemia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Decreased (Hypocalcemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Creatinine Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Increased (Hypermagnesemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Decreased (Hypomagnesemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Increased (Hyperkalemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Decreased (Hypokalemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Increased (Hyperglycemia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Increased (Hyperglycemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Decreased (Hypoglycemia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Decreased (Hypoglycemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Glucose Decreased (Hypoglycemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | ALT Increased, Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | ALT Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | ALT Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Albumin Decreased (Hypoalbuminemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Albumin Decreased (Hypoalbuminemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Alkaline phosphatase Increased, Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Alkaline phosphatase Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Alkaline phosphatase Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | AST Increased, Any Grade Increase | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | AST Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Blood bilirubin Increased, Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Blood bilirubin Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Blood bilirubin Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Increased (Hypercalcemia), Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Increased (Hypercalcemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Increased (Hypercalcemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Calcium Decreased (Hypocalcemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | CPK Increased, Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | CPK Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | CPK Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Creatinine Increased, Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Creatinine Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | GGT Increased, Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | GGT Increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | GGT Increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Increased (Hypermagnesemia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Increased (Hypermagnesemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Decreased (Hypomagnesemia), Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Magnesium Decreased (Hypomagnesemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Phosphate Decreased (Hypophosphatemia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Phosphate Decreased (Hypophosphatemia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Phosphate Decreased (Hypophosphatemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Increased (Hyperkalemia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Increased (Hyperkalemia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Decreased (Hypokalemia), Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Potassium Decreased (Hypokalemia), Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Increased (Hypernatremia), Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Increased (Hypernatremia), Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Increased (Hypernatremia), Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Decreased (Hyponatremia), Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Sodium Decreased (Hyponatremia), Increase to Grade 3 | 2 Participants |
Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.03. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Data for worst-case post baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.
Time frame: Baseline (Day 1) and up to approximately 31 months
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Any Grade Increase | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 2 | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Any Grade Increase | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 2 | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 2 | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Any Grade Increase | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Any Grade Increase | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 2 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | SBP, Increase to Grade 3 | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP) | DBP, Increase to Grade 3 | 0 Participants |
Part 2 - Percentage of Participants With Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed partial response (PR) or better (i.e., PR, very good partial response \[VGPR\], complete response \[CR\] and stringent complete response \[sCR\]), according to the International Myeloma Working Group (IMWG) Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h.
Time frame: Up to approximately 31 months
Population: All Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Percentage of Participants With Overall Response Rate (ORR) | 43 Percentage of Participants |
Part 1 - Area Under Plasma Concentration-time Curve (AUC) From Time 0 to End of the Dosing Interval [AUC (0-tau)] for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 1 - AUC (0-tau) for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.
Part 1 - AUC (0-tau) for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - AUC (0-tau) for Total mAb After First Dose | 6237.2 h*ug/mL | Geometric Coefficient of Variation 17.9 |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - AUC (0-tau) for Total mAb After First Dose | 10817.8 h*ug/mL | Geometric Coefficient of Variation 48.5 |
Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose | 155.27 h*ug/mL | — |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - AUC From Time 0 to 168 h After Dosing [AUC (0-168h)] for Cys-mcMMAF After First Dose | 90.61 h*ug/mL | Geometric Coefficient of Variation 34.5 |
Part 1 - C-EOI for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Cys-mcMMAF After First Dose | 0.7110 ng/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Cys-mcMMAF After First Dose | 0.7630 ng/mL |
Part 1 - C-EOI for Total mAb
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, Cycle 5, Cycle 8, and Cycle 11
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 8 | 63.70 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 1 | 40.15 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 2 | 53.90 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 5 | 54.65 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 11 | 65.40 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 11 | 54.80 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 8 | 39.75 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 5 | 73.90 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 2 | 64.65 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - C-EOI for Total mAb | Cycle 1 | 65.30 ug/mL |
Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose | 1.5799 ng/mL | Geometric Coefficient of Variation 30.4 |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Cmax for Cysteine Maleimidocaproyl Monomethyl Auristatin F (Cys-mcMMAF) After First Dose | 1.0966 ng/mL | Geometric Coefficient of Variation 40.9 |
Part 1 - Cmax for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.
Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose | 43.57 ug/mL | Geometric Coefficient of Variation 7.1 |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Cmax for Total Monoclonal Antibody (mAb) After First Dose | 64.45 ug/mL | Geometric Coefficient of Variation 21.5 |
Part 1 - Ctrough for Total mAb
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1, Cycle 4, Cycle 7, Cycle 10, and Cycle 13
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Ctrough for Total mAb | Cycle 4 | 8.91 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Ctrough for Total mAb | Cycle 10 | 18.40 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Ctrough for Total mAb | Cycle 1 | 5.420 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Ctrough for Total mAb | Cycle 13 | 18.05 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Ctrough for Total mAb | Cycle 7 | 26.90 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Ctrough for Total mAb | Cycle 1 | 13.350 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Ctrough for Total mAb | Cycle 7 | 45.05 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Ctrough for Total mAb | Cycle 4 | 18.80 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Ctrough for Total mAb | Cycle 10 | 21.70 ug/mL |
Part 1 - End of Infusion Concentration (C-EOI) for Belantamab Mafodotin
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose | 501.800 Hour |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast) for Total mAb After First Dose | 481.580 Hour |
Part 1 - Maximum Concentration (Cmax) for Belantamab Mafodotin After First Dose
Blood samples were collected for Pharmacokinetic (PK) analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, end of infusion (EOI), 2, 4, 9, and 24 h post-SOI (start of infusion) on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic (PK) Population included participants in the all treated population from whom at least one PK sample was obtained and analyzed for belantamab mafodotin. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study.
Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Baseline | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | End of Treatment | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | Baseline | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Belantamab Mafodotin | End of Treatment | 0 Participants |
Part 1 - Percentage of Participants With Overall Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed PR or better (i.e., PR, VGPR, CR and sCR), according to the IMWG Response Criteria. CR = negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow; sCR=stringent complete response, CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; VGPR = serum and urine M-component detectable by immunofixation but not on electrophoresis OR \>= 90% reduction in serum M-component plus urine M-component \<100 mg/24 h; PR = \>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg/24 h.
Time frame: Up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Percentage of Participants With Overall Response Rate (ORR) | 67 Percentage of Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Percentage of Participants With Overall Response Rate (ORR) | 43 Percentage of Participants |
Part 1 - Time of Cmax (Tmax) for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 1 - Titers of ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.
Part 1 - Tlast for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Tlast for Cys-mcMMAF After First Dose | 161.380 Hour |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Tlast for Cys-mcMMAF After First Dose | 171.250 Hour |
Part 1 - Tmax for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Tmax for Cys-mcMMAF After First Dose | 13.510 Hour |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Tmax for Cys-mcMMAF After First Dose | 4.120 Hour |
Part 1 - Tmax for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.
Part 1 - Tmax for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Tmax for Total mAb After First Dose | 1.100 Hour |
| Main Study Phase- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | Part 1 - Tmax for Total mAb After First Dose | 1.520 Hour |
Part 1 - Trough Concentration Prior to the Next Dose for Each Cycle (Ctrough) for Belantamab Mafodotin
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, and Cycle 1 Day 8
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - AUC (0-168 h) for Cys-mcMMAF After First Dose | 128.38 h*ug/mL | Geometric Coefficient of Variation 70.9 |
Part 2 - AUC (0-tau) for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 2 - AUC (0-tau) for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.
Part 2 - AUC (0-tau) for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - AUC (0-tau) for Total mAb After First Dose | 7949.0 h*ug/mL | Geometric Coefficient of Variation 27.2 |
Part 2 - C-EOI for Belantamab Mafodotin
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of each 21 day Cycle till Cycle 11
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 2 - C-EOI for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - C-EOI for Cys-mcMMAF After First Dose | 0.3150 ng/mL |
Part 2 - C-EOI for Total mAb
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, and Cycle 5
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - C-EOI for Total mAb | Cycle 1 | 48.60 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - C-EOI for Total mAb | Cycle 2 | 53.00 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - C-EOI for Total mAb | Cycle 5 | 52.35 ug/mL |
Part 2 - Changes From Baseline in Urine pH
Urine samples were collected from participants to assess urine pH levels. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Changes From Baseline in Urine pH | Baseline | 5.71 Potential of Hydrogen (pH) | Standard Deviation 0.844 |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Changes From Baseline in Urine pH | End of Treatment | 0.10 Potential of Hydrogen (pH) | Standard Deviation 0.687 |
Part 2 - Changes From Baseline in Urine Specific Gravity
Urine samples were collected from participants to assess urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date
Time frame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Changes From Baseline in Urine Specific Gravity | End of Treatment | -0.0001 Ratio | Standard Deviation 0.00813 |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Changes From Baseline in Urine Specific Gravity | Baseline | 1.0171 Ratio | Standard Deviation 0.00965 |
Part 2 - Cmax for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 2 - Cmax for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Cmax for Cys-mcMMAF After First Dose | 1.2481 ng/mL | Geometric Coefficient of Variation 111.5 |
Part 2 - Cmax for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.
Part 2 - Cmax for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Cmax for Total mAb After First Dose | 46.70 ug/mL | Geometric Coefficient of Variation 23.3 |
Part 2 - Ctrough for Belantamab Mafodotin
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose on Day 1 of each 21 day cycle from Cycle 1 until Cycle 13
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 2 - Ctrough for Total mAb
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
Time frame: Cycle 1 and Cycle 4
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Ctrough for Total mAb | Cycle 1 | 7.735 ug/mL |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Ctrough for Total mAb | Cycle 4 | 11.60 ug/mL |
Part 2 - Duration of First Occurrence of Worsening in BCVA Score
The time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event is resolved (change from baseline logMAR score \< 0.3 in both eyes) was used to calculate the duration of first occurrence.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Duration of First Occurrence of Worsening in BCVA Score | 47.0 Days |
Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score
The time taken for the resolution of worsening eye post treatment exposure. Duration was defined as the time from onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) until the event was considered resolved (change from baseline logMAR score \< 0.3 in both eyes). It required at least a one day gap between the resolution of all events from first occurrence to the onset of second occurrence. The end of treatment exposure was defined as 20 days from last infusion date.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Duration of Resolution Post-treatment Exposure of Worsening in BCVA Score | 34.5 Days |
Part 2 - Duration of Response
Duration of response was defined as the time from first documented evidence of PR or better, to the time when disease progression (PD) is documented per IMWG response criteria; or death due to PD occurs among participants who achieve an overall response, i.e. confirmed PR or better. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h). PR = ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to \<200 mg/24 h.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Duration of Response | 7.6 Months |
Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision
A definite worsened vision was defined as a change from baseline \>=0.3 logMAR score.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision | One | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision | Two | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants According to the Number of Definite Events of Worsening of Vision | Three or more | 3 Participants |
Part 2 - Number of Participants With AEs and SAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations which involve medical or scientific judgment or is associated with liver injury and impaired liver function.
Time frame: Up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With AEs and SAEs | AEs | 27 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With AEs and SAEs | SAEs | 5 Participants |
Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any maximum worst-case change from baseline categories are presented for right and left eyes. No change/improved vision is defined as a change from baseline \<0.12; a possible worsened vision is defined as a change from baseline \>=0.12 to \<0.3; a definite worsened vision is defined as a change from baseline \>=0.3 logMAR score. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye, No change/improved vision | 14 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye, Definite worsened vision | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores | Left Eye, Possible worsened vision | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye, No change/improved vision | 16 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye, Possible worsened vision | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores | Right Eye, Definite worsened vision | 7 Participants |
Part 2 - Number of Participants With Post-baseline Decline in BCVA to Light Perception or no Light Perception
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. Data was not collected
Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were tested in screening assay, and positive samples were further characterized for antibody titers. At the time of primary results posting, there was no participants with positive ADA results. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and until end of treatment (up to 178 weeks)
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin | Baseline | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Post-baseline Positive ADAs Against Belantamab Mafodotin | End of Treatment | 0 Participants |
Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score
The event was considered resolved if the change from baseline in logMAR score \< 0.3 in both eyes.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score | Resolved | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score | Not resolved, follow-up ongoing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Resolution of Post Treatment Exposure Worsening in BCVA Score | Not resolved, follow-up ended | 2 Participants |
Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings
Participants with worse case punctate keratopathy findings post baseline at any ocular exam by right eye, left eye and worse eye are presented as none, mild, moderate and severe. Worse eye indicates the eye with the worst visual acuity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Right eye, Worst findings | Mild | 11 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Right eye, Worst findings | Moderate | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Left eye, Worst findings | Mild | 9 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Left eye, Worst findings | Moderate | 9 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Right eye, Most frequent findings | Mild | 14 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Right eye, Most frequent findings | Moderate | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Left eye, Most frequent findings | Mild | 13 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Left eye, Most frequent findings | Moderate | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Left eye, Most frequent findings | Severe | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Worst eye, Most frequent findings | None | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Worst eye, Most frequent findings | Mild | 14 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Right eye, Worst findings | None | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Right eye, Worst findings | Severe | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Left eye, Worst findings | None | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Left eye, Worst findings | Severe | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Worst eye, Worst findings | None | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Worst eye, Worst findings | Mild | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Worst eye, Worst findings | Moderate | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Worst eye, Worst findings | Severe | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Right eye, Most frequent findings | None | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Right eye, Most frequent findings | Severe | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Left eye, Most frequent findings | None | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Worst eye, Most frequent findings | Moderate | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worse Case Post-baseline Punctate Keratopathy Findings | Worst eye, Most frequent findings | Severe | 0 Participants |
Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature
Vital signs (pulse rate and temperature) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. The abnormal vital sign ranges were: For pulse rate (low \<60 beats per minute \[bpm\] and high \>100 bpm); For body temperature (\<=35 degrees Celsius or \>=38 degrees Celsius). Participants were counted in the worst case category that their value changed to (low, normal or high), unless there was no change in their category. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Pulse Rate, To High | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Temperature, To Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Temperature, To Normal or No Change | 23 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Temperature, To High | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Pulse Rate, To Low | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change From Baseline in Vital Signs: Pulse Rate and Body Temperature | Pulse Rate, To Normal or No Change | 11 Participants |
Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: basophils, eosinophils, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), Erythrocytes, hematocrit, monocytes, neutrophils and reticulocyte. The summaries of worst-case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Increase to High | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Change to Normal or No Change | 26 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Change to Normal or No Change | 23 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Change to Normal or No Change | 22 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Basophils, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Eosinophils, Change to Normal or No Change | 22 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Decrease to Low | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Change to Normal or No Change | 24 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCHC, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Decrease to Low | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Change to Normal or No Change | 16 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCH, Increase to High | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Change to Normal or No Change | 25 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | MCV, Increase to High | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Erythrocytes, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Decrease to Low | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Hematocrit, Increase to High | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Change to Normal or No Change | 20 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Monocytes, Increase to High | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Neutrophils, Segmented, Decrease to Low | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Neutrophils, Segmented, Change to Normal or No Change | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Neutrophils, Segmented, Increase to High | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Change to Normal or No Change | 14 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Reticulocytes, Increase to High | 5 Participants |
Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters
Blood samples were collected for the analysis of following chemistry parameters: calcium, carbon dioxide, chloride, direct bilirubin, protein, thyrotropin (TSH), thyroxine (T4) and triiodothyronine (T3). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst case change from baseline with respect to normal range was analyzed for only those laboratory tests that were not gradable by CTCAE version 4.03. The number of participants with decreases to low, changes to normal or no changes from baseline, and increases to high values have been presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed. Participants are counted twice if the participant has values that changed Decreased to Low and Increased to High, so the sum of the percentages may not add to 100% for each row
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Carbon Dioxide, Change to Normal or No Change | 14 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Carbon Dioxide, Increase to High | 9 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Direct Bilirubin, Increase to High | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Calcium, Decrease to Low | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Calcium, Change to Normal or No Change | 18 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Calcium, Increase to High | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Carbon Dioxide, Decrease to Low | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Chloride, Decrease to Low | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Chloride, Change to Normal or No Change | 20 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Chloride, Increase to High | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Direct Bilirubin, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Direct Bilirubin, Change to Normal or No Change | 15 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Protein, Decrease to Low | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Protein, Change to Normal or No Change | 18 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | Protein, Increase to High | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | TSH, Decrease to Low | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | TSH, Change to Normal or No Change | 17 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | TSH, Increase to High | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T4, Free, Decrease to Low | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T4, Free, Change to Normal or No Change | 23 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline in Lab Chemistry Parameters | T4, Free, Increase to High | 1 Participants |
Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results
Urine samples were collected to assess urine glucose, protein, occult blood and ketones using dipstick method. The dipstick test gave results in a semi-quantitative manner, and results for urinalysis parameters were recorded as negative, trace, 1+, 2+, 3+ indicating proportional concentrations in the urine sample. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Result for uranalysis parameters were recorded as no change/decreased and any increase. Data for worst-case post baseline are presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Glucose, No Change/Decreased | 25 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Glucose, Any Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Ketones, No Change/Decreased | 21 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Ketones, Any Increase | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Occult Blood, No Change/Decreased | 15 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Occult Blood, Any Increase | 9 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Protein, No Change/Decreased | 20 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Change Post-baseline Urinalysis Results | Protein, Any Increase | 6 Participants |
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters
Blood samples were collected for the analysis of following hematology parameters: hemoglobin, White blood cell (WBC) count, lymphocytes, neutrophils and platelet. The laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 3 | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Hemoglobin increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 4 | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Any Grade Increase | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelet count decreased, Increase to Grade 3 | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Anemia, Any Grade Increase | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Leukocytosis, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC decreased, Any Grade Increase | 11 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC decreased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | WBC decreased, Increase to Grade 4 | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Any Grade Increase | 14 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count decreased, Increase to Grade 3 | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Lymphocyte count increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophil count decreased, Any Grade Increase | 9 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophil count decreased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Neutrophil count decreased, Increase to Grade 4 | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelet count decreased, Any Grade Increase | 18 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Hematology Parameters | Platelet count decreased, Increase to Grade 4 | 4 Participants |
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters
Blood samples were collected for the analysis of clinical chemistry parameters: glucose, alanine aminotransferase (ALT), albumin, alkaline phosphatase, aspartate aminotransferase (AST), blood bilirubin, calcium, creatine kinase (CPK), creatinine, gamma glutamyl transferase (GGT), magnesium, phosphate potassium and sodium. Laboratory parameters were graded according to NCI-CTCAE version 4.03. Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity and an increase in CTCAE grade was defined relative to the Baseline grade. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Any worst case post baseline increase in grade along with any increase to a maximum grade of 3 and a maximum grade of 4 are presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypoalbuminemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Alkaline phosphatase increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypercalcemia, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypercalcemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypocalcemia, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | CPK increased, Any Grade Increase | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | CPK increased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Creatinine increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypermagnesemia, Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypermagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypokalemia, Any Grade Increase | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hyponatremia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hyperglycemia, Any Grade Increase | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hyperglycemia, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hyperglycemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypoglycemia, Any Grade Increase | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypoglycemia, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypoglycemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | ALT increased, Any Grade Increase | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | ALT increased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | ALT increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypoalbuminemia, Any Grade Increase | 9 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypoalbuminemia, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Alkaline phosphatase increased, Any Grade Increase | 9 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Alkaline phosphatase increased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | AST increased, Any Grade Increase | 20 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | AST increased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | AST increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Blood bilirubin increased, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Blood bilirubin increased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Blood bilirubin increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypercalcemia, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypocalcemia, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypocalcemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | CPK increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Creatinine increased, Any Grade Increase | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Creatinine increased, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | GGT increased, Any Grade Increase | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | GGT increased, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | GGT increased, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypermagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypomagnesemia, Any Grade Increase | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypomagnesemia, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypomagnesemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypophosphatemia, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypophosphatemia, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypophosphatemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hyperkalemia, Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hyperkalemia, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hyperkalemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypokalemia, Increase to Grade 3 | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypokalemia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypernatremia, Any Grade Increase | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypernatremia, Increase to Grade 3 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hypernatremia, Increase to Grade 4 | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hyponatremia, Any Grade Increase | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Lab Chemistry Parameters | Hyponatremia, Increase to Grade 3 | 1 Participants |
Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Data for worst-case post Baseline with any grade increase and a maximum post-baseline grade increase to Grade 3 from their baseline grade are presented.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP | SBP, Increase to Grade 3 | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP | DBP, Any Grade Increase | 20 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP | DBP, Increase to Grade 2 | 12 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP | DBP, Increase to Grade 3 | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP | SBP, Any Grade Increase | 24 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Grade Change From Baseline in Vital Signs: DBP and SBP | SBP, Increase to Grade 2 | 16 Participants |
Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations
Participants with worst-case shift from baseline in corneal examination: corneal ulcer, epithelial microcystic edema, subepithelial haze, corneal neovascularization and microcysts without edema, by right eye (R), left eye (L) and worse eye (W) are presented as yes (Y), no (N) and missing (M). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator left eye | Baseline N, Post-Baseline N | 23 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator right eye | Baseline N, Post-Baseline N | 21 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator right eye | Baseline N, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator right eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator right eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator right eye | Baseline Missing, Post-Baseline N | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator right eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator right eye | Baseline Missing, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator worst eye | Baseline N, Post-Baseline N | 23 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator worst eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator worst eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator right eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator right eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator left eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator left eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator left eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator left eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator left eye | Baseline Missing, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator left eye | Baseline Missing, Post-Baseline Y | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator left eye | Baseline Missing, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator right eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator right eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator right eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator right eye | Baseline Missing, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator worst eye | Baseline N, Post-Baseline Y | 15 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator worst eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator worst eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator worst eye | Baseline Missing, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator left eye | Baseline N, Post-Baseline N | 22 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator left eye | Baseline N, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator left eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator left eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator left eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator right eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator right eye | Baseline Missing, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator right eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator right eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator worst eye | Baseline N, Post-Baseline N | 21 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator worst eye | Baseline N, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator worst eye | Baseline N, Post-Baseline Missing | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator worst eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator right eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator right eye | Baseline Missing, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator right eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator right eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator worst eye | Baseline N, Post-Baseline N | 17 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator worst eye | Baseline N, Post-Baseline Y | 9 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator worst eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator worst eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator worst eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator worst eye | Baseline Missing, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator worst eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator worst eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator left eye | Baseline N, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator left eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator left eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator left eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator left eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator left eye | Baseline Missing, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator left eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator left eye | Baseline Missing, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator right eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator right eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator worst eye | Baseline N, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator worst eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator worst eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator worst eye | Baseline Missing, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator worst eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal ulcer indicator worst eye | Baseline Missing, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator left eye | Baseline N, Post-Baseline N | 17 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator left eye | Baseline N, Post-Baseline Y | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator left eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator left eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator left eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator left eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator left eye | Baseline Missing, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator left eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator left eye | Baseline Missing, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator right eye | Baseline N, Post-Baseline N | 16 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator right eye | Baseline N, Post-Baseline Y | 5 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator right eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator right eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator right eye | Baseline Missing, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator right eye | Baseline Missing, Post-Baseline Y | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator right eye | Baseline Missing, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator worst eye | Baseline N, Post-Baseline N | 17 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator worst eye | Baseline N, Post-Baseline Y | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator worst eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator worst eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator worst eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator worst eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator worst eye | Baseline Missing, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator worst eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Epithelial microcystic edema indicator worst eye | Baseline Missing, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator left eye | Baseline N, Post-Baseline N | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator left eye | Baseline N, Post-Baseline Y | 15 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator right eye | Baseline N, Post-Baseline N | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator right eye | Baseline N, Post-Baseline Y | 14 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator right eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator right eye | Baseline Missing, Post-Baseline Y | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator right eye | Baseline Missing, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator worst eye | Baseline N, Post-Baseline N | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator worst eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator worst eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator worst eye | Baseline Missing, Post-Baseline Y | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Microcysts without edema indicator worst eye | Baseline Missing, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator left eye | Baseline N, Post-Baseline Missing | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator left eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator left eye | Baseline Missing, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator left eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator right eye | Baseline N, Post-Baseline N | 20 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator right eye | Baseline N, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator right eye | Baseline N, Post-Baseline Missing | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator right eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator right eye | Baseline Y, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator worst eye | Baseline Y, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator worst eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator worst eye | Baseline Missing, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator worst eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Corneal neovascularization indicator worst eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator left eye | Baseline N, Post-Baseline N | 16 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator left eye | Baseline N, Post-Baseline Y | 9 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator left eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator left eye | Baseline Y, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator left eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator left eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator left eye | Baseline Missing, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator left eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator left eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator right eye | Baseline N, Post-Baseline N | 16 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator right eye | Baseline N, Post-Baseline Y | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator right eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator right eye | Baseline Y, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator right eye | Baseline Y, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Corneal Examinations | Subepithelial haze indicator worst eye | Baseline N, Post-Baseline Missing | 1 Participants |
Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations
Participants with worst-case shift from baseline in corneal examination which included: clear, pseudophakia, nuclear sclerosis, cortical cataract and posterior subcapsular cataract by right eye, left eye and worse eye are presented as yes (Y), no (N) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Right eye | Baseline Y, Post-Baseline Missing | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Right eye | Baseline Missing, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Right eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Worse eye | Baseline N, Post-Baseline N | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Worse eye | Baseline N, Post-Baseline Y | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Worse eye | Baseline N, Post-Baseline N=Missing | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Worse eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Worse eye | Baseline Missing, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Worse eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Worse eye | Baseline Missing, Post-Baseline Missing | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Left eye | Baseline N, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Right eye | Baseline N, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Right eye | Baseline N, Post-Baseline N=Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Right eye | Baseline Y, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Left eye | Baseline Y, Post-Baseline Y | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Left eye | Baseline Y, Post-Baseline Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Right eye | Baseline Missing, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Worse eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Left eye | Baseline N, Post-Baseline N | 12 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Left eye | Baseline N, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Left eye | Baseline N, Post-Baseline N=Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Left eye | Baseline Y, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Left eye | Baseline Y, Post-Baseline Y | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Left eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Left eye | Baseline Missing, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Left eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Left eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Right eye | Baseline N, Post-Baseline N | 12 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Right eye | Baseline N, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Right eye | Baseline N, Post-Baseline N=Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Right eye | Baseline Y, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Right eye | Baseline Y, Post-Baseline Y | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Right eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Right eye | Baseline Missing, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Right eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, Right eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, worse eye | Baseline N, Post-Baseline N | 12 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, worse eye | Baseline N, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, worse eye | Baseline N, Post-Baseline N=Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, worse eye | Baseline Y, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, worse eye | Baseline Y, Post-Baseline Y | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, worse eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, worse eye | Baseline Missing, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, worse eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Clear Indicator, worse eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Left eye | Baseline N, Post-Baseline N | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Left eye | Baseline N, Post-Baseline Y | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Left eye | Baseline N, Post-Baseline N=Missing | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Left eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Left eye | Baseline Y, Post-Baseline Y | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Left eye | Baseline Y, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Left eye | Baseline Missing, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Left eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Left eye | Baseline Missing, Post-Baseline Missing | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Right eye | Baseline N, Post-Baseline N | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Right eye | Baseline N, Post-Baseline Y | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Right eye | Baseline N, Post-Baseline N=Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Right eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Right eye | Baseline Y, Post-Baseline Y | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Right eye | Baseline Missing, Post-Baseline Missing | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Worse eye | Baseline Y, Post-Baseline Y | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Cortical Cataract Indicator, Worse eye | Baseline Y, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Left eye | Baseline N, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Left eye | Baseline N, Post-Baseline N=Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Left eye | Baseline Y, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Left eye | Baseline Y, Post-Baseline Y | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Left eye | Baseline Y, Post-Baseline Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Left eye | Baseline Missing, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Left eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Left eye | Baseline Missing, Post-Baseline Missing | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Right eye | Baseline N, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Right eye | Baseline Y, Post-Baseline Y | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Right eye | Baseline Y, Post-Baseline Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Right eye | Baseline Missing, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Right eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Right eye | Baseline Missing, Post-Baseline Missing | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Worse eye | Baseline N, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Worse eye | Baseline N, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Worse eye | Baseline N, Post-Baseline N=Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Worse eye | Baseline Y, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Worse eye | Baseline Y, Post-Baseline Y | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Worse eye | Baseline Y, Post-Baseline Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Worse eye | Baseline Missing, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Worse eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Nuclear Sclerosis, Worse eye | Baseline Missing, Post-Baseline Missing | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Left eye | Baseline N, Post-Baseline N | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Left eye | Baseline N, Post-Baseline Y | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Left eye | Baseline N, Post-Baseline N=Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Left eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Left eye | Baseline Missing, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Left eye | Baseline Missing, Post-Baseline Y | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Left eye | Baseline Missing, Post-Baseline Missing | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Right eye | Baseline N, Post-Baseline N | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Right eye | Baseline N, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Right eye | Baseline N, Post-Baseline N=Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Right eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Left eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Right eye | Baseline Y, Post-Baseline Y | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Right eye | Baseline Y, Post-Baseline Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Right eye | Baseline Missing, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Right eye | Baseline Missing, Post-Baseline Y | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Right eye | Baseline Missing, Post-Baseline Missing | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Worse eye | Baseline N, Post-Baseline N | 6 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Worse eye | Baseline N, Post-Baseline Y | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Worse eye | Baseline N, Post-Baseline N=Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Worse eye | Baseline Y, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Worse eye | Baseline Y, Post-Baseline Y | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Worse eye | Baseline Y, Post-Baseline Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Worse eye | Baseline Missing, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Worse eye | Baseline Missing, Post-Baseline Y | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Posterior Subcapsular Cataract, Worse eye | Baseline Missing, Post-Baseline Missing | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Left eye | Baseline N, Post-Baseline N | 11 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Left eye | Baseline N, Post-Baseline Y | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Left eye | Baseline N, Post-Baseline N=Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Left eye | Baseline Y, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Left eye | Baseline Y, Post-Baseline Y | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Left eye | Baseline Missing, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Left eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Left eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Right eye | Baseline N, Post-Baseline N | 12 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Right eye | Baseline N, Post-Baseline Y | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Right eye | Baseline N, Post-Baseline N=Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Right eye | Baseline Y, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Right eye | Baseline Y, Post-Baseline Y | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Right eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Right eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Right eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Worse eye | Baseline N, Post-Baseline N | 11 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Worse eye | Baseline N, Post-Baseline Y | 4 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Worse eye | Baseline N, Post-Baseline N=Missing | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Worse eye | Baseline Y, Post-Baseline Y | 10 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Worse eye | Baseline Y, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Worse eye | Baseline Missing, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Worse eye | Baseline Missing, Post-Baseline Y | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Lens Examinations | Pseudophakia, Worse eye | Baseline Missing, Post-Baseline Missing | 0 Participants |
Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam
Participants with worst-case shift from baseline in corneal epithelium defects by right eye, left eye and worse eye are presented as normal (N), abnormal (AN) and missing. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Left Eye | Baseline AN, Post-Baseline AN | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Right Eye | Baseline N, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Right Eye | Baseline N, Post-Baseline AN | 16 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Right Eye | Baseline AN, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Right Eye | Baseline AN, Post-Baseline AN | 8 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Right Eye | Baseline N, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Right Eye | Baseline AN, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Left Eye | Baseline N, Post-Baseline N | 2 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Left Eye | Baseline N, Post-Baseline AN | 16 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Left Eye | Baseline AN, Post-Baseline N | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Left Eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Left Eye | Baseline AN, Post-Baseline Missing | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Worse Eye | Baseline N, Post-Baseline N | 3 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Worse Eye | Baseline N, Post-Baseline AN | 17 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Worse Eye | Baseline AN, Post-Baseline N | 0 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Worse Eye | Baseline AN, Post-Baseline AN | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Worse Eye | Baseline N, Post-Baseline Missing | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Number of Participants With Worst-case Shift From Baseline in Ophthalmological Epithelium Exam | Worse Eye | Baseline AN, Post-Baseline Missing | 0 Participants |
Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score
The onset of any visual acuity event (change from baseline in logMAR score \>= 0.3 in either eye) was considered resolved if the change from baseline in logMAR score was less than 0.3 in both eyes. Participants with resolved and not resolved outcome of the worsening eye were presented.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score | Not resolved | 1 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score | Resolved prior to end of treatment exposure | 7 Participants |
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Outcome of First Occurrence of Worsening Eye in BCVA Score | Resolved post end of treatment exposure | 2 Participants |
Part 2 - Overall Survival
Overall Survival was defined as the time from first dose until death due to any cause.
Time frame: Up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Overall Survival | NA Months |
Part 2 - Percentage of Participants With Clinical Benefit Rate
Clinical benefit rate was defined as the percentage of participants with a confirmed minimal response (MR) or better according to the IMWG Response Criteria. MR is \>= 25% but \< 49% reduction of serum M-protein and reduction in 24-hour urinary M-protein by 50-89%.
Time frame: Up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Percentage of Participants With Clinical Benefit Rate | 43 Percentage of Participants |
Part 2 - Progression-free Survival
Progression-free survival was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to any cause. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).
Time frame: Up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Progression-free Survival | 2.5 Months |
Part 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score
The time for the onset of any visual acuity event (change from baseline logMAR score \>= 0.3 in either eye) was calculated.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Time Taken for the Onset of First Occurrence of Worsening in BCVA Score | 78.0 Days |
Part 2 - Time to Best Response
Time to best response was defined as the time between the date of first dose and the first best documented response (PR or better) among participants who achieved a confirmed response of PR or better.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Time to Best Response | 1.7 Months |
Part 2 - Time to Disease Progression
Time to disease progression was defined as the time from first dose until the earliest date of PD per IMWG response criteria, or death due to PD. PD= Increase of 25% from lowest confirmed response value in 1 or more of the following criteria: Serum M-protein with absolute increase of \>= 0.5 g/dL; Serum M-protein increase \>= 1 g/dL if the lowest M-component was \>=5 g/dL; Urinary M-protein (absolute increase must be \>= 200 mg per 24 h).
Time frame: Up to approximately 178 weeks
Population: All Treated Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Time to Disease Progression | 2.5 Months |
Part 2 - Time to Response
Time to response (TTR) was defined as the time between the date of first dose and the first documented evidence of response (PR or better) among participants who achieved a confirmed response of PR or better.
Time frame: Up to approximately 178 weeks
Population: All Treated Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Time to Response | 0.7 Months |
Part 2 - Titers of ADAs Against Belantamab Mafodotin
Serum samples collected for the analysis of the presence of ADAs using validated immunoassays. All samples were to be further tested in screening assay, and positive samples were further to be characterized for antibody titers.
Time frame: Baseline (Day 1) and up to approximately 178 weeks
Population: All Treated Population. There were no participants with positive ADA results. Hence the titer (concentration) of ADA was not collected.
Part 2 - Tlast for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 2 - Tlast for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Tlast for Cys-mcMMAF After First Dose | 167.510 Hour |
Part 2 - Tlast for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Tlast for Total mAb After First Dose | 503.140 Hour |
Part 2 - Tmax for Belantamab Mafodotin After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Due to bioanalytical issues, PK data were not collected and analyzed for belantamab mafodotin. Therefore, this PK parameter was not reported in this study
Part 2 - Tmax for Cys-mcMMAF After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods. Tlast is the time of last observed quantifiable concentration of belantamab mafodotin in Cycle 1 which extended beyond protocol defined duration for some participants across treatment groups.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Tmax for Cys-mcMMAF After First Dose | 23.580 Hour |
Part 2 - Tmax for Pembrolizumab After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, 9, and 24 h post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Pembrolizumab data were not collected and analyzed. Therefore, this PK parameter was not reported in this study.
Part 2 - Tmax for Total mAb After First Dose
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Time frame: Pre-dose, EOI, 2, 4, and 24 hour post-SOI on Cycle 1 Day 1, Cycle 1 Day 4, Cycle 1 Day 8, and pre-dose on Cycle 2 Day 1
Population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | Part 2 - Tmax for Total mAb After First Dose | 0.945 Hour |