Non-Hodgkin's Lymphoma, Hodgkin Lymphoma, Multiple Myeloma
Conditions
Brief summary
The purpose of this study is to determine the side effects of treatment of the combination of nivolumab and daratumumab in participants with relapsed/refractory multiple myeloma.
Detailed description
NOTE: Currently, this study is only open to nivolumab+daratumumab vs daratumumab monotherapy in multiple myeloma patients.
Interventions
BIOLOGICALNivolumab
Administered by intravenous (IV) infusion
BIOLOGICALIpilimumab
Administered by IV infusion
BIOLOGICALLirilumab
Administered by IV infusion
BIOLOGICALDaratumumab
Administered by IV infusion
DRUGPomalidomide
Administered PO
DRUGDexamethasone
Administered PO and by IV infusion
Sponsors
Janssen, LP
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Have received at least 3 prior lines of therapy, including a proteasome inhibitor \[PI\] and an immunomodulatory agent \[IMiD\] OR have disease that is double refractory to a PI and IMiD * More than 12 weeks post-transplant of your own blood forming stem cells (autologous transplant) * Have detectable disease measured by a specific protein in your blood and/or urine * Must consent to bone marrow aspirate or biopsy.
Exclusion criteria
* Solitary bone or extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia, or monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, POEMS syndrome or active plasma cell leukemia * Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti CTLA 4, or anti-CD38 antibody, or allogeneic stem cell transplantation * Seropositive for human immunodeficiency virus (HIV), Hepatitis B surface antigen or Hepatitis C antibody positive (except if HCV-RNA negative), or history of active chronic hepatitis B or C * History of central nervous system involvement or symptoms suggestive of central nervous system involvement by multiple myeloma Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Experienced Drug Related Grade 3-4 AEs | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug. |
| Number of Participants That Experienced Drug Related Grade 3-4 SAEs | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | Number and percent of participants that experienced drug related Grade 3-4 SAEs occurring up to 100 days after the last dose of study drug. |
| Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug. |
| Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | — |
| Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | — |
| Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | — |
| Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | approximately up to 4 years | — |
| Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | approximately up to 4 years | — |
| Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | approximately up to 4 years | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | Time to MRD Negativity status in specific NGS and NGF sensitivity levels |
| Objective Response Rate in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | — |
| Duration of Response in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | — |
| Progression Free Survival in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | — |
| Cmax in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | Maximum observed serum concentration |
| Best Overall Response | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response |
| Cmin in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | Serum concentration achieved at the end of dosing interval (trough concentration) |
| AUC (0-T) in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration |
| AUC (TAU) in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | Area under the concentration-time curve in one dosing interval |
| End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days | Serum concentration achieved at the end of study drug infusion |
| Tmax in the Nivolumab + Daratumumab Cohort | approximately up to 4 years | Time of maximum observed serum concentration |
| Best Overall Response - Multiple Myeloma Group | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. |
| Duration of Response | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to approximately 37 months Nivo Liri: approximately up to 4 years 1 month | the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Remission and Partial Remission |
| Duration of Response - Multiple Myeloma Group | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month | the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response |
| Progression Free Survival | From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months) | Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment. |
| Progression Free Survival Rate | From randomization to the specified timepoints (up to 48 months) | The percentage of participants remaining progression free at the specified timepoints (up to 48 Months) |
| Overall Survival | Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to3 years Nivo Liri: approximately up to 4 years 1 month | The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method |
| Number of Participants With PD-L1 Expression | At baseline (prior to start of study treatment) | Number of Participants with PD-L1 expression in the following categories * baseline PD-L1 expression ≥ 1% * baseline PD-L1 expression \< 1% * without PD-L1 quantifiable at baseline |
| Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score | From baseline (last measurement before start of study treatment) to last available measurement after start of study treatment (88 weeks for Nivo mono, 93 weeks for nivo+ipi, 25 weeks for nivo+liri) | mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions. There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4). The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome). |
Countries
Belgium, France, Greece, Italy, Poland, United States
Participant flow
Recruitment details
For the phase 1 nivo monotherapy dose escalation included in this study, it was derived from CA209-003. It was concluded that 3mg/kg of nivolumab would be used for the dose expansion phase 2 of this study (CA209-039) based on the conclusions derived from CA209-003.
Pre-assignment details
316 participants treated
Participants by arm
| Arm | Count |
|---|---|
| Nivolumab Monotherapy (Expansion) 3mg/kg of nivolumab | 105 |
| Nivolumab + Ipilimumab 3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W | 65 |
| Nivolumab + Lirilumab 3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W | 72 |
| Nivolumab + Daratumumab_Cohort A1 ND regimen: Nivolumab (240 mg up to cycle 6, then 480 mg) + Daratumumab (16 mg/Kg) | 6 |
| Nivolumab + Daratumumab_Cohort A2 ND-PD regimen; Nivolumab + Daratumumab + Pomalidomide + Dexamethasone | 7 |
| Nivolumab + Daratumumab_Cohort B1 ND regimen: Nivolumab (240 mg cycle 1, then 480 mg) + Daratumumab (16 mg/Kg) | 43 |
| Nivolumab + Daratumumab_Cohort B2 D regimen: Daratumumab alone | 22 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | AE unrelated to study drug | 4 | 3 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Disease Progression | 62 | 16 | 52 | 3 | 3 | 31 | 14 |
| Overall Study | Maximum clinical benefit | 11 | 1 | 7 | 1 | 0 | 0 | 0 |
| Overall Study | No longer meets study criteria | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Not Treated | 0 | 0 | 0 | 0 | 2 | 2 | 0 |
| Overall Study | Other Reasons | 6 | 0 | 10 | 0 | 0 | 1 | 0 |
| Overall Study | Request to discontinue study treatment | 5 | 0 | 2 | 0 | 1 | 2 | 0 |
| Overall Study | Study Drug Toxicity | 14 | 3 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrew consent | 1 | 2 | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Nivolumab Monotherapy (Expansion) | Nivolumab + Ipilimumab | Nivolumab + Lirilumab | Nivolumab + Daratumumab_Cohort A1 | Nivolumab + Daratumumab_Cohort A2 | Nivolumab + Daratumumab_Cohort B1 | Nivolumab + Daratumumab_Cohort B2 | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 39 Participants | 19 Participants | 20 Participants | 3 Participants | 4 Participants | 26 Participants | 11 Participants | 122 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants | 46 Participants | 52 Participants | 3 Participants | 3 Participants | 17 Participants | 11 Participants | 198 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 91 Participants | 62 Participants | 69 Participants | 6 Participants | 7 Participants | 28 Participants | 17 Participants | 280 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 13 Participants | 5 Participants | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 5 Participants | 7 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 26 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 4 Participants | 1 Participants | 11 Participants |
| Race (NIH/OMB) White | 89 Participants | 58 Participants | 63 Participants | 5 Participants | 7 Participants | 38 Participants | 19 Participants | 279 Participants |
| Sex: Female, Male Female | 45 Participants | 28 Participants | 26 Participants | 3 Participants | 3 Participants | 25 Participants | 8 Participants | 138 Participants |
| Sex: Female, Male Male | 60 Participants | 37 Participants | 46 Participants | 3 Participants | 4 Participants | 18 Participants | 14 Participants | 182 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 53 / 105 | 33 / 65 | 42 / 72 | 1 / 6 | 3 / 7 | 24 / 42 | 13 / 23 |
| other Total, other adverse events | 102 / 105 | 62 / 65 | 69 / 72 | 6 / 6 | 5 / 5 | 35 / 41 | 16 / 22 |
| serious Total, serious adverse events | 50 / 105 | 39 / 65 | 34 / 72 | 3 / 6 | 5 / 5 | 15 / 41 | 9 / 22 |
Outcome results
Primary
Number of Participants That Experienced Drug Related Grade 3-4 AEs
Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants That Experienced Drug Related Grade 3-4 AEs | 19 Participants |
| Nivolumab + Ipilimumab | Number of Participants That Experienced Drug Related Grade 3-4 AEs | 18 Participants |
| Nivolumab + Lirilumab | Number of Participants That Experienced Drug Related Grade 3-4 AEs | 0 Participants |
Primary
Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Population: All treated participants in the nivo dara cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort | 5 Participants |
| Nivolumab + Lirilumab | Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort | 13 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants That Experienced Drug-related Grade 3-4 AEs in the Nivolumab + Daratumumab Cohort | 2 Participants |
Primary
Number of Participants That Experienced Drug Related Grade 3-4 SAEs
Number and percent of participants that experienced drug related Grade 3-4 SAEs occurring up to 100 days after the last dose of study drug.
Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Population: All Treated Participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants That Experienced Drug Related Grade 3-4 SAEs | 28 Participants |
| Nivolumab + Ipilimumab | Number of Participants That Experienced Drug Related Grade 3-4 SAEs | 8 Participants |
| Nivolumab + Lirilumab | Number of Participants That Experienced Drug Related Grade 3-4 SAEs | 3 Participants |
Primary
Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Population: All treated participants in the nivo dara cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort | 4 Participants |
| Nivolumab + Lirilumab | Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort | 10 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort | 6 Participants |
Primary
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
Time frame: approximately up to 4 years
Population: All treated participants in the nivo dara cohort
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 2 | 2 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 1 | 2 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 4 | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 1 | 2 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 1 | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 4 | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 0 | 3 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 3 | 2 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 3 | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 4 | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 1 | 2 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 2 | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 2 | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 2 | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 0 | 3 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 1 | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 3 | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 3 | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 4 | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 3 | 2 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 2 | 2 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 4 | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 0 | 3 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 0 | 2 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 0 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 3 | 3 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 4 | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 0 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 1 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 1 | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 2 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 3 | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 4 | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 2 | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 4 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 0 | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 0 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 1 | 3 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 2 | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 0 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 3 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 4 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 0 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 1 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 2 | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 3 | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 4 | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 1 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 2 | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 3 | 3 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 0 | 14 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 4 | 4 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 3 | 5 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 1 | 6 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 0 | 6 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 0 | 3 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 3 | 15 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 2 | 15 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 3 | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 1 | 13 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 2 | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 3 | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 2 | 6 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 0 | 10 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 1 | 11 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 1 | 8 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 2 | 3 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 1 | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 0 | 19 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 4 | 1 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 3 | 3 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 4 | 0 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 2 | 20 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 4 | 2 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 4 | 5 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 2 | 5 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 3 | 2 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 0 | 5 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 0 | 3 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 1 | 5 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 0 | 1 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 1 | 13 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Hemoglobin | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 0 | 8 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 1 | 9 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 2 | 3 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 3 | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Platelet count | Grade 4 | 1 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 1 | 9 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 2 | 5 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 3 | 2 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Leukocytes | Grade 4 | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 2 | 7 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 3 | 5 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Lymphocytes (Absolute) | Grade 4 | 1 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 0 | 10 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 1 | 6 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 2 | 6 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology | Absolute Neutrophil Count | Grade 3 | 0 Participants |
Primary
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver
Time frame: approximately up to 4 years
Population: All treated participants in the nivo dara cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >5xULN | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN with total Bilirubin > 2xULN within 1 day | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | Total Bilirubin > 2xULN | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN with total Bilirubin >2xULN within 30 days | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >10xULN | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >20xULN | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN with total Bilirubin > 2xULN within 1 day | 3 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >20xULN | 3 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >10xULN | 3 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | Total Bilirubin > 2xULN | 3 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >5xULN | 3 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN with total Bilirubin >2xULN within 30 days | 3 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN | 0 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >20xULN | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN | 0 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >5xULN | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >10xULN | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | Total Bilirubin > 2xULN | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN with total Bilirubin > 2xULN within 1 day | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN with total Bilirubin >2xULN within 30 days | 9 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >10xULN | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN with total Bilirubin >2xULN within 30 days | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN with total Bilirubin > 2xULN within 1 day | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >5xULN | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >3xULN | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | Total Bilirubin > 2xULN | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Liver | ALT or AST >20xULN | 0 Participants |
Primary
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid
Time frame: approximately up to 4 years
Population: All treated participants in the nivo dara cohort with at Least One On-Treatment TSH Measurement
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (A) | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | WITH FT3/FT4 TEST MISSING | 2 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH>ULN | 3 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH TSH >= LLN AT BASELINE | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH TSH >= LLN AT BASELINE | 2 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (A) | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH>ULN | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN | 2 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 1 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN | 2 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | WITH FT3/FT4 TEST MISSING | 2 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH>ULN | 8 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH TSH >= LLN AT BASELINE | 2 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (A) | 1 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 7 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 5 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH TSH >= LLN AT BASELINE | 1 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH>ULN | 3 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 2 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (A) | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 2 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | WITH FT3/FT4 TEST MISSING | 1 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN | 2 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Nivolumab + Daratumumab_Cohort B2 | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 2 Participants |
Primary
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver
Number and percent of participants that experienced drug related Grade 3-4 AEs occurring up to 100 days after the last dose of study drug.
Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 5XULN | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 10XULN | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 3XULN | 3 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 20XULN | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 10XULN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 3XULN | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 5XULN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | TOTAL BILIRUBIN > 2XULN | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS | 0 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | TOTAL BILIRUBIN > 2XULN | 2 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 3XULN | 4 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN 30 DAYS | 1 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | CONCURRENT ALT OR AST ELEVATION > 3XULN WITH TOTAL BILIRUBIN > 2XULN WITHIN ONE DAY | 1 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 20XULN | 0 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 5XULN | 2 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Liver | ALT OR AST > 10XULN | 1 Participants |
Primary
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid
Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Population: All Treated Participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN | 14 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 11 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 8 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 13 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN | 8 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH TSH >= LLN AT BASELINE | 5 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 0 Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN | 19 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN | 6 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 13 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH TSH >= LLN AT BASELINE | 6 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 11 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 7 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 5 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Nivolumab + Ipilimumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN | 1 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN | 0 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH FT3/FT4 TEST MISSING | 5 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN WITH TSH >= LLN AT BASELINE | 4 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH FT3/FT4 TEST MISSING | 13 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN | 1 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN | 15 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH TSH <= ULN AT BASELINE | 9 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH < LLN | 6 Participants |
| Nivolumab + Lirilumab | Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade - Thyroid | TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN | 1 Participants |
Secondary
AUC (0-T) in the Nivolumab + Daratumumab Cohort
Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration
Time frame: approximately up to 4 years
Population: All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
Secondary
AUC (TAU) in the Nivolumab + Daratumumab Cohort
Area under the concentration-time curve in one dosing interval
Time frame: approximately up to 4 years
Population: All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
Secondary
Best Overall Response
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response
Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Population: All treated participants with available measurements (excluding Multiple Myeloma (MM) Group)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Best Overall Response | Complete Response | 10.4 Percentage of participants |
| Nivolumab Monotherapy (Expansion) | Best Overall Response | Partial Response | 33.8 Percentage of participants |
| Nivolumab + Ipilimumab | Best Overall Response | Complete Response | 13.8 Percentage of participants |
| Nivolumab + Ipilimumab | Best Overall Response | Partial Response | 34.5 Percentage of participants |
| Nivolumab + Lirilumab | Best Overall Response | Complete Response | 9.7 Percentage of participants |
| Nivolumab + Lirilumab | Best Overall Response | Partial Response | 29.0 Percentage of participants |
Secondary
Best Overall Response - Multiple Myeloma Group
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy.
Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Population: All Treated participants with available measurements in the Multiple Myeloma (MM) Group
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Best Overall Response - Multiple Myeloma Group | Complete Remission | 3.7 Percentage |
| Nivolumab Monotherapy (Expansion) | Best Overall Response - Multiple Myeloma Group | Stringent Compete Response | 0 Percentage |
| Nivolumab Monotherapy (Expansion) | Best Overall Response - Multiple Myeloma Group | Very Good Partial Response | 0 Percentage |
| Nivolumab Monotherapy (Expansion) | Best Overall Response - Multiple Myeloma Group | Partial Remission | 0 Percentage |
| Nivolumab + Ipilimumab | Best Overall Response - Multiple Myeloma Group | Stringent Compete Response | 0 Percentage |
| Nivolumab + Ipilimumab | Best Overall Response - Multiple Myeloma Group | Complete Remission | 0 Percentage |
| Nivolumab + Ipilimumab | Best Overall Response - Multiple Myeloma Group | Partial Remission | 0 Percentage |
| Nivolumab + Ipilimumab | Best Overall Response - Multiple Myeloma Group | Very Good Partial Response | 0 Percentage |
| Nivolumab + Lirilumab | Best Overall Response - Multiple Myeloma Group | Partial Remission | 0 Percentage |
| Nivolumab + Lirilumab | Best Overall Response - Multiple Myeloma Group | Complete Remission | 0 Percentage |
Secondary
Cmax in the Nivolumab + Daratumumab Cohort
Maximum observed serum concentration
Time frame: approximately up to 4 years
Population: All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
Secondary
Cmin in the Nivolumab + Daratumumab Cohort
Serum concentration achieved at the end of dosing interval (trough concentration)
Time frame: approximately up to 4 years
Population: All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
Secondary
Duration of Response
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Remission and Partial Remission
Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to approximately 37 months Nivo Liri: approximately up to 4 years 1 month
Population: All Responding participants (Complete Response and Partial Response) with available measurements (excluding Multiple Myeloma (MM) Group)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Duration of Response | 22.83 Months |
| Nivolumab + Ipilimumab | Duration of Response | 24.84 Months |
| Nivolumab + Lirilumab | Duration of Response | 19.38 Months |
Secondary
Duration of Response in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Population: All randomized participants in the nivo dara cohort
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Duration of Response in the Nivolumab + Daratumumab Cohort | NA Months |
| Nivolumab + Ipilimumab | Duration of Response in the Nivolumab + Daratumumab Cohort | NA Months |
| Nivolumab + Lirilumab | Duration of Response in the Nivolumab + Daratumumab Cohort | 6.70 Months |
| Nivolumab + Daratumumab_Cohort B2 | Duration of Response in the Nivolumab + Daratumumab Cohort | 12.98 Months |
Secondary
Duration of Response - Multiple Myeloma Group
the best response designation over the study as a whole, recorded between the date of first dose and the last efficacy assessment prior to subsequent therapy. Measured in Complete Response and Partial Response
Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to 5 months Nivo Liri: approximately up to 4 years 1 month
Population: All Responding participants (Complete Response and Partial Response) in the Multiple Myeloma (MM) Group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Duration of Response - Multiple Myeloma Group | NA Months |
Secondary
End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort
Serum concentration achieved at the end of study drug infusion
Time frame: Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days
Population: All treated participants in the nivo dara cohort - pharmacokinetic subset
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 3 | 105.14 ug/mL | Standard Deviation 31.41 |
| Nivolumab Monotherapy (Expansion) | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 1 | 57.28 ug/mL | Standard Deviation 6.78 |
| Nivolumab Monotherapy (Expansion) | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 7 | 227.75 ug/mL | Standard Deviation 26.79 |
| Nivolumab + Ipilimumab | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 11 | 206.00 ug/mL | — |
| Nivolumab + Ipilimumab | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 7 | 206.00 ug/mL | — |
| Nivolumab + Lirilumab | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 2 | 175.73 ug/mL | Standard Deviation 88.94 |
| Nivolumab + Lirilumab | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 11 | 212.00 ug/mL | Standard Deviation 38.2 |
| Nivolumab + Lirilumab | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 3 | 193.38 ug/mL | Standard Deviation 69.74 |
| Nivolumab + Lirilumab | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 5 | 208.14 ug/mL | Standard Deviation 58.38 |
| Nivolumab + Lirilumab | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 7 | 193.00 ug/mL | Standard Deviation 70.06 |
| Nivolumab + Lirilumab | End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort | Cycle 1 | 69.59 ug/mL | Standard Deviation 18.79 |
Secondary
Number of Participants With PD-L1 Expression
Number of Participants with PD-L1 expression in the following categories * baseline PD-L1 expression ≥ 1% * baseline PD-L1 expression \< 1% * without PD-L1 quantifiable at baseline
Time frame: At baseline (prior to start of study treatment)
Population: All Treated Participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Number of Participants With PD-L1 Expression | Baseline PD-L1 expression ≥ 1% | 25 Number of Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With PD-L1 Expression | Baseline PD-L1 expression < 1% | 16 Number of Participants |
| Nivolumab Monotherapy (Expansion) | Number of Participants With PD-L1 Expression | PD-L1 not quantifiable at baseline | 64 Number of Participants |
| Nivolumab + Ipilimumab | Number of Participants With PD-L1 Expression | Baseline PD-L1 expression < 1% | 14 Number of Participants |
| Nivolumab + Ipilimumab | Number of Participants With PD-L1 Expression | PD-L1 not quantifiable at baseline | 25 Number of Participants |
| Nivolumab + Ipilimumab | Number of Participants With PD-L1 Expression | Baseline PD-L1 expression ≥ 1% | 26 Number of Participants |
| Nivolumab + Lirilumab | Number of Participants With PD-L1 Expression | Baseline PD-L1 expression < 1% | 20 Number of Participants |
| Nivolumab + Lirilumab | Number of Participants With PD-L1 Expression | PD-L1 not quantifiable at baseline | 36 Number of Participants |
| Nivolumab + Lirilumab | Number of Participants With PD-L1 Expression | Baseline PD-L1 expression ≥ 1% | 16 Number of Participants |
Secondary
Objective Response Rate in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Population: All randomized participants in the nivo dara cohort
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Objective Response Rate in the Nivolumab + Daratumumab Cohort | 66.7 Percentage |
| Nivolumab + Ipilimumab | Objective Response Rate in the Nivolumab + Daratumumab Cohort | 71.4 Percentage |
| Nivolumab + Lirilumab | Objective Response Rate in the Nivolumab + Daratumumab Cohort | 51.2 Percentage |
| Nivolumab + Daratumumab_Cohort B2 | Objective Response Rate in the Nivolumab + Daratumumab Cohort | 36.4 Percentage |
Secondary
Overall Survival
The percentage of participants remaining alive. Median values are computed using Kaplan-Meier method
Time frame: Nivo Mono: approximately up to 6 years and 9 months Nivo Ipi: approximately up to3 years Nivo Liri: approximately up to 4 years 1 month
Population: All Treated Participants with available measurements
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Overall Survival | 52.57 Months |
| Nivolumab + Ipilimumab | Overall Survival | 30.39 Months |
| Nivolumab + Lirilumab | Overall Survival | 14.95 Months |
Secondary
Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score
mSWAT is a scoring technique involving the direct assessment of the percentage of body-surface-area (BSA) affected by skin lesions. There are 12 body regions (each one assigned a different percentage of BSA). For each body region, the assigned BSA percentage is multiplied by a factor weighing the type and severity of lesion observed (patch= x1, plaque = x2, tumor= x4). The sum of the individual body region sub-scores is then summed to generate the final mSWAT score, which ranges from 0 (best outcome) to 400 (worst outcome).
Time frame: From baseline (last measurement before start of study treatment) to last available measurement after start of study treatment (88 weeks for Nivo mono, 93 weeks for nivo+ipi, 25 weeks for nivo+liri)
Population: All Treated Participants with cutaneous T Cell lymphoma and available measurements
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score | 8.70 Percent of change from baseline |
| Nivolumab + Ipilimumab | Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score | 63.03 Percent of change from baseline |
| Nivolumab + Lirilumab | Percentage Change From Baseline in the Modified Severity Weighted Assessment Tool (mSWAT) Score | -39.49 Percent of change from baseline |
Secondary
Progression Free Survival
Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment.
Time frame: From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)
Population: All Treated Participants with available measurements
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Progression Free Survival | 6.24 Months |
| Nivolumab + Ipilimumab | Progression Free Survival | 6.93 Months |
| Nivolumab + Lirilumab | Progression Free Survival | 3.02 Months |
Secondary
Progression Free Survival in the Nivolumab + Daratumumab Cohort
Time frame: approximately up to 4 years
Population: All randomized participants in the nivo dara cohort
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nivolumab Monotherapy (Expansion) | Progression Free Survival in the Nivolumab + Daratumumab Cohort | 7.56 Months |
| Nivolumab + Ipilimumab | Progression Free Survival in the Nivolumab + Daratumumab Cohort | 16.95 Months |
| Nivolumab + Lirilumab | Progression Free Survival in the Nivolumab + Daratumumab Cohort | 7.49 Months |
| Nivolumab + Daratumumab_Cohort B2 | Progression Free Survival in the Nivolumab + Daratumumab Cohort | 7.01 Months |
Secondary
Progression Free Survival Rate
The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)
Time frame: From randomization to the specified timepoints (up to 48 months)
Population: All Treated Participants with available measurements
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Progression Free Survival Rate | 48 Months | 13.2 Percentage of Participants |
| Nivolumab Monotherapy (Expansion) | Progression Free Survival Rate | 12 Months | 34.8 Percentage of Participants |
| Nivolumab Monotherapy (Expansion) | Progression Free Survival Rate | 6 Months | 50.5 Percentage of Participants |
| Nivolumab Monotherapy (Expansion) | Progression Free Survival Rate | 18 Months | 31.0 Percentage of Participants |
| Nivolumab Monotherapy (Expansion) | Progression Free Survival Rate | 24 Months | 20.3 Percentage of Participants |
| Nivolumab Monotherapy (Expansion) | Progression Free Survival Rate | 36 Months | 15.8 Percentage of Participants |
| Nivolumab + Ipilimumab | Progression Free Survival Rate | 24 Months | 30.9 Percentage of Participants |
| Nivolumab + Ipilimumab | Progression Free Survival Rate | 18 Months | 40.1 Percentage of Participants |
| Nivolumab + Ipilimumab | Progression Free Survival Rate | 12 Months | 45.3 Percentage of Participants |
| Nivolumab + Ipilimumab | Progression Free Survival Rate | 6 Months | 51.5 Percentage of Participants |
| Nivolumab + Lirilumab | Progression Free Survival Rate | 2 Months | 58.0 Percentage of Participants |
| Nivolumab + Lirilumab | Progression Free Survival Rate | 6 Months | 34.3 Percentage of Participants |
| Nivolumab + Lirilumab | Progression Free Survival Rate | 9 Months | 32.5 Percentage of Participants |
| Nivolumab + Lirilumab | Progression Free Survival Rate | 4 Months | 42.4 Percentage of Participants |
Secondary
Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort
Time to MRD Negativity status in specific NGS and NGF sensitivity levels
Time frame: approximately up to 4 years
Population: All Randomized MRD Evaluable Subjects Achieving MRD Negativity
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nivolumab Monotherapy (Expansion) | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGS sensitivity level=10e-4 | 3.02 Months | — |
| Nivolumab Monotherapy (Expansion) | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGS sensitivity level=10e-6 | 30.85 Months | — |
| Nivolumab Monotherapy (Expansion) | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGS sensitivity level=10e-5 | 3.02 Months | — |
| Nivolumab + Lirilumab | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGF sensitivity level=10e-4 | 2.94 Months | Standard Deviation 0.23 |
| Nivolumab + Lirilumab | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGS sensitivity level=10e-4 | 3.60 Months | Standard Deviation 2.409 |
| Nivolumab + Lirilumab | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGF sensitivity level=10e-5 | 6.97 Months | Standard Deviation 6.776 |
| Nivolumab + Lirilumab | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGF sensitivity level=10e-6 | 12.30 Months | Standard Deviation 3.508 |
| Nivolumab + Lirilumab | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGS sensitivity level=10e-5 | 5.45 Months | Standard Deviation 4.788 |
| Nivolumab + Daratumumab_Cohort B2 | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGF sensitivity level=10e-4 | 4.20 Months | Standard Deviation 2.766 |
| Nivolumab + Daratumumab_Cohort B2 | Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort | NGS sensitivity level=10e-4 | 2.83 Months | — |
Secondary
Tmax in the Nivolumab + Daratumumab Cohort
Time of maximum observed serum concentration
Time frame: approximately up to 4 years
Population: All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0