Fallopian Tube Cancer, Platinum-resistant Ovarian Cancer (PROC), Primary Peritoneal Cancer, Renal Cell Carcinoma (RCC), Serous Epithelial Ovarian Cancer, Urothelial Carcinoma
Conditions
Keywords
DSP-7888, Nelatimotide, Adegramotide, immune checkpoint inhibitor, cancer vaccine, WT1, ICI, Wilms Tumor 1, Ombipepimut-S, nivolumab, Opdivo, pembrolizumab, Keytruda, Ovarian cancer, Platinum-resistant ovarian cancer, PROC, Serous epithelial ovarian cancer, High-grade serous epithelial ovarian cancer, HGSOC, Fallopian tube cancer, FTC, Peritoneal cancer, Primary peritoneal cancer, PPC, Renal cell carcinoma, Kidney cancer, RCC, Metastatic Renal Cell Carcinoma, Metastatic RCC, Metastatic kidney cancer, Advanced Renal Cell Carcinoma, Advanced RCC, Advanced kidney cancer, Urothelial carcinoma, Bladder cancer, Transitional cell carcinoma, UC, Metastatic urothelial carcinoma, Metastatic transitional cell carcinoma, Metastatic UC, Advanced urothelial carcinoma, Advanced UC, Advanced transitional cell carcinoma
Brief summary
This is a Phase 1b/2, open-label, multicenter study of DSP-7888 Dosing Emulsion in combination with checkpoint inhibitors (nivolumab or pembrolizumab) in adult patients with solid tumors, that consists of 2 parts: dose search part of the study (Phase 1b and Phase 1b Enrichment Cohort) and the dose expansion part of the study (Phase 2). In Phase 1b of this study there will be 2 arms: Arm 1 and Arm 2. In Arm 1, there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and nivolumab and in Arm 2 there will be 6 to 12 patients who will be dosed with DSP-7888 Dosing Emulsion and pembrolizumab. In addition, an enrichment cohort of a further 10 patients who have locally advanced or metastatic Renal Cell Carcinoma or Urothelial Cancer with primary or acquired resistance to previous checkpoint inhibitors will be enrolled into Phase 1b of the study to help evaluate the preliminary antitumor activity of DSP-7888 Dosing Emulsion at the safe dose level identified in the dose-search part of the study, and will be dosed with DSP-7888 Dosing Emulsion and nivolumab, or DSP-7888 Dosing Emulsion and pembrolizumab, as per the investigator's preference. At the safe, recommended dose determined in Phase 1b, platinum-resistant ovarian cancer (PROC) patients will be enrolled in Phase 2 of the study with DSP-7888 Dosing Emulsion, exploring the combination with pembrolizumab (Arm 2). In Phase 2, approximately 40 patients with PROC will be initially enrolled; additional patients may be enrolled to further assess anti-tumor activities, but the total sample size will not exceed 60 patients. This brings the total maximum study population to approximately 84 patients.
Interventions
DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm.
DRUGNivolumab
Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
DRUGPembrolizumab
Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Phase 1b: Patients must fulfill each of the following requirements: 1. Phase 1b Dose Search Part Only: A histologically or cytologically confirmed cancer that is metastatic and is approved to be treated with nivolumab or pembrolizumab with the following origins: * Nivolumab: unresectable or metastatic melanoma, metastatic NSCLC, advanced RCC, recurrent or metastatic squamous cell carcinoma of the head and neck, locally advanced or metastatic urothelial carcinoma, hepatocellular carcinoma, MSI-H/dMMR colorectal cancer * Pembrolizumab: unresectable or metastatic melanoma, metastatic NSCLC, recurrent or metastatic squamous cell carcinoma of the head and neck, locally advanced or metastatic urothelial carcinoma, unresectable or metastatic MSI-H/dMMR solid tumors, recurrent locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, recurrent or metastatic cervical cancer In addition, the following requirements must be fulfilled: 1. Patients must not be considered eligible for a potentially curative resection. 2. Patients who are eligible for PD-1 therapy based on either criterion (i) or (ii) below: (i) Patients progressed on their prior treatment before initiating treatment on current study, OR (ii) Patients who are currently being treated with nivolumab or pembrolizumab and have achieved at least stable disease (SD), and who, in the judgment of their treating physicians, could benefit from the addition of DSP-7888 Dosing Emulsion vaccine to improve or maintain their response. Phase 1b Enrichment Cohort Only: Patients with locally advanced or metastatic RCC or urothelial carcinoma who have experienced disease progression per iRECIST (iCPD) during or within 3 months of last dose of the most recent prior anti-PD-1/ PD-L1-based treatment 2. Patients must be positive for at least 1 of the following human leukocyte antigens: 1. HLA-A\*02:01 2. HLA-A\*02:06 3. HLA-A\*24:02 4. HLA-A\*03:01 5. HLA-B\*15:01 3. ≥ 18 years of age 4. Eastern Cooperative Oncology group (ECOG) performance status of 0 or 1 5. Patients must be able to provide archival tumor tissue with sufficient tumor tissue, or patients must consent to undergo tumor biopsy to acquire sufficient tissue before first administration of study 6. Females of childbearing potential must have a negative serum pregnancy test 7. Male or female patients of child-producing potential must agree to use contraception or use prevention of pregnancy measures (true abstinence) during the study and for 6 months (for females and males alike) after the last dose 8. Total bilirubin of ≤ 2.0 mg/dL (≤ 3.0 mg/dL for patients with known Gilbert's syndrome) 9. Aspartate aminotransferase (AST) ≤ 3.0 × the upper limit of normal (ULN) or \< 5 × ULN if considered to be due to liver metastases 10. Alanine transaminase (ALT) ≤ 3.0 × the upper limit of normal (ULN) or \< 5 × ULN if considered to be due to liver metastases 11. Glomerular Filtration Rate \> 40 mL/min 12. Multigated acquisition (MUGA) scan or echocardiogram with left ventricular ejection fraction (LVEF) \> 40% 13. Life expectancy ≥ 3 months 14. Patients must be willing to provide a signed and dated ICF
Exclusion criteria
Phase 1b: Patients with any of the following will be excluded from the study: 1. Anticancer chemotherapy (including molecular targeted drugs), immunotherapy, radiotherapy, or investigational agents within 4 weeks of the first dose of DSP 7888 Dosing Emulsion 2. Major surgery within 4 weeks prior to study treatment 3. Patients who have received a live vaccine within 4 weeks prior to the first dose 4. Any known, untreated brain metastases; patients with treated brain metastases must be clinically stable for 4 weeks after completion of treatment for brain metastases and have radiographic image documentation of stability. Patients must have no clinical symptoms from brain metastases and not have required systemic corticosteroids \> 10 mg/day prednisone or equivalent for at least 2 weeks prior to the first dose of study drug 5. Patients who have multifocal glioblastoma 6. Pregnant or breastfeeding 7. Patients who have an active autoimmune disease requiring immunosuppression \> 10 mg/day prednisone or equivalent a. Patients with controlled hyperthyroidism must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to study drug administration 8. Patients who have interstitial lung disease or active, non-infectious pneumonitis 9. Known hypersensitivity to a component of protocol therapy: 1. Patients with known hypersensitivity to any of the components of DSP-7888 Dosing Emulsion. 2. Patients with known hypersensitivity to nivolumab or pembrolizumab are excluded from receiving combination therapy that includes the agent to which they are hypersensitive 10. Uncontrolled concurrent illness including, but not limited to: ongoing or active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy; clinically significant non-healing or healing wounds; symptomatic congestive heart failure; unstable angina pectoris; severe and/or uncontrolled cardiac arrhythmia; significant pulmonary disease; or, psychiatric illness/social situations that would limit compliance with study requirements 11. Patients with a history of another primary cancer with the exception of: (a) curatively resected non-melanoma skin cancer; (b) curatively treated cervical carcinoma in situ; (c) localized prostate cancer not requiring systemic therapy; and d) any another cancer from which the patient has been disease free for ≥ 2 years that, in the opinion of the Investigator and medical monitor for the Sponsor, will not affect patient outcome in the setting of the current diagnosis 12. Patients who have a QTcF (QT corrected based on Fridericia's equation) interval \> 480 msec (CTCAE = Grade 2) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g. heart failure, hypokalemia, family history of long QT interval syndrome) at screening 13. Patients who have a medical history of frequent or sustained ventricular ectopy 14. Patients who have, in the opinion of the treating Investigator, any concurrent conditions that could pose an undue medical hazard or interfere with the interpretation of the study results 15. Known history of human immunodeficiency virus (HIV) infection, active hepatitis B, or untreated hepatitis C 16. Patients who have baseline signs and symptoms consistent with clinically significant, decreased pulmonary function: (1) blood saturation oxygen level (SpO2) \< 90% at rest on room air; (2) dyspnea at rest or required supplemental oxygen within 2 weeks of study enrollment Inclusion Criteria Phase 2: Patients eligible for inclusion must meet all of the following criteria: 1\. Patients must be female ≥ 18 years of age, able to understand study procedures, and subsequently agreed to participate in the study by providing a written informed consent obtained prior to any prescreening and screening procedures that are not standard of care 2. Patients must be positive for at least 1 of the following human leukocyte antigens (HLA): a. HLA-A\*02:01 b. HLA-A\*02:06 c. HLA-A\*24:02 d. HLA-A\*03:01 e. HLA-B\*15:01 3\. Patients must have histologically diagnosed ovarian, fallopian tube, or primary peritoneal cancer with predominantly high-grade (Grade 2 or 3) serous epithelial features 4. Patients must be considered platinum resistant to last administered platinum-based therapy, defined as patient relapsed within 6 months after last dose of platinum-based therapy 5. Patients must have completed at least 1 but no more than 4 prior lines of therapy for serous epithelial ovarian, fallopian tube, or primary peritoneal cancer; 1. Maintenance is not considered a separate line of treatment (even if patients with BRCA mutation positive received PARP-inhibitor following induction therapy with a platinum doublet including bevacizumab, etc.) 2. Neoadjuvant and adjuvant systemic therapy will be counted as one line of therapy 3. Patients must have received at least one platinum-based therapy 6\. Patients must have progression disease after last therapy and have measurable disease according to RECIST (v1.1). 7\. Patients must have an ECOG performance status of 0 or 1. 8. Patients must have adequate organ function, defined as follows: Hematological: 1. Absolute neutrophil count (ANC) ≥ 1,500/μL (without granulocyte-colony stimulating factor (G-CSF)) 2. Platelets ≥ 100,000/μL (without transfusion) 3. Hemoglobin ≥ 9.0 g/dL (without transfusion) Renal: a. Serum Creatinine OR estimated glomerular filtration rate using the Cockcroft-Gault equation ≤ 1.5 × the upper limit of normal (ULN) OR 40 mL/min using the Cockcroft-Gault equation for patients with creatinine levels \> 1.5 × ULN Hepatic: 1. Serum total bilirubin ≤ 1.5 ULN 2. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 × ULN OR ≤ 5 × ULN for patients with liver metastases Cardiac: 1. Multigated acquisition (MUGA) scan or echocardiogram with left ventricular ejection fraction (LVEF) ≥ 40%. 2. QTcF (QT corrected based on Fridericia's equation) interval \< 480 msec Coagulation: 1. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × ULN 2. Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤ 1.5 × ULN 9\. Patients must provide a fresh tissue biopsy, if medically feasible, or archival tissue as either a formalin-fixed and paraffin embedded FFPE) block or newly sectioned tissue on charged slides (equivalent to approximately 8-23 slides sectioned at 4-5μm thickness) 10. Patients of childbearing potential must have a negative serum or urine pregnancy test at screening 11. Patients must be either postmenopausal, free from menses \> 12 months, surgically sterilized, or willing to use adequate contraception to prevent pregnancy or must agree to abstain from heterosexual activity throughout the study, starting with enrollment through 6 months after the last dose of study treatment 12. Life expectancy ≥ 3 months 13. Patients who had stayed on the last treatment for at least 12 weeks without any evidence of progression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events and Serious Adverse Events | From the date of signing informed consent until 30 days after last dose for an average of 3 months. | — |
| Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs). | 28 days | The RP2D was based on the data collected during phase 1b. |
| Phase II: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab in Patients With Platinum-resistant Ovarian Cancer (PROC). | Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months | Defined as the proportion of patients who have achieved confirmed Complete Response or Partial Response by RECIST v1.1 based on investigator assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase Ib: Progression-free Survival (PFS) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab | Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months | The percentage of participants with a complete response or partial response who have measurable disease at baseline imaging. |
| Phase Ib: The 6-month Progression-free Survival (PFS) Rate of Ombipepimut-S in Combination With Nivolumab or Pembrolizumab | 6 months | Defined as the proportion of patients who neither progressed by RECIST (v.1.1) nor died before 6 months (24 weeks) from the first study treatment |
| Phase Ib: Percentage of Patients With Overall Survival (OS) When Treated With Ombipepimut-S in Combination With Nivolumab or Pembrolizumab | 12 months | — |
| Phase II: Assessment of the Duration of Response (DOR) of Ombipepimut-S in Combination With Pembrolizumab | Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression up to 24 months. | Defined as the time from the first documentation of a response (CR or PR) until time of first documentation of disease progression by RECIST v1.1 or death by any cause. |
| Phase II: Disease Control Rate of Ombipepimut-S in Combination With Pembrolizumab | Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months. | Defined as the percentage of patients who have achieved best overall response (BOR) of complete response, partial response, or stable disease per RECIST (v.1.1) |
| Phase II: Assessment of the Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab | Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months | Defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST v.1.1, or death by any cause |
| Phase Ib: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab | At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion | Defined as the proportion of patients who have achieved confirmed complete response (CR) or partial response (PR) evaluated using RECIST v1.1 and iRECIST. |
| Phase II: Overall Survival of Patients Treated With Ombipepimut-S in Combination With Pembrolizumab | Every 3 months from last dose of study treatment up to 24 months. | Defined as the time from the date of first dose of study treatment to the date of death by any cause |
| Phase II: Immune Objective Response Rate (iORR) of Ombipepimut-S in Combination With Pembrolizumab | Up to 24 months | Defined as the percentage of patients who have achieved confirmed immune complete response (iCR) or immune partial response (iPR), evaluated using iRECIST based on investigator's assessment. |
| Phase II: Immune Disease Control Rate (iDCR) of Ombipepimut-S in Combination With Pembrolizumab | Up to 24 months | Defined as the percentage of patients who have achieved best overall response of iCR, iPR, or immune stable disease (iSD), per iRECIST |
| Phase II: Immune Progression-free Survival (iPFS) of Ombipepimut-S in Combination With Pembrolizumab | Up to 24 months | Defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by iRECIST or death by any cause |
| Phase II: Immune Duration of Response (iDOR) of Ombipepimut-S in Combination With Pembrolizumab | Up to 24 months | Defined as the time from the first documentation of response (iCR or iPR) until time of first documentation of disease progression by iRECIST, or death by any cause |
| Phase II: Evaluation of the Safety and Tolerability of Ombipepimut-S in Combination With Pembrolizumab | Up to 24 months | Demonstrated by the number of participants with adverse events and serious adverse events |
| Phase II: 6-month Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab | 6 months | PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST (v.1.1), or death by any cause |
| Phase Ib: The Disease Control Rate (DCR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab | At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion | Defined as the percentage of patients who have achieved best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 and iRECIST. |
| Phase Ib: Assessment of the Duration of Response (DOR) of Ombipepimut-S in Combination With Nivolumab or Pembrolizumab | At week 4 for patients on the nivolumab arm and week 6 for patients on the pembrolizumab arm. Thereafter weeks 12, 18 and 24 and every 12 weeks until progression or death. | DOR is defined as the time from first documentation of response until the time of first documentation of disease progression by RECIST v1.1 and iRECIST or death by any cause. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Participants who died, withdrew consent to survival follow up or were lost to follow up were considered to have completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1b - Arm 1 DSP-7888 Dosing Emulsion in combination with Nivolumab
DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm.
Nivolumab: Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study. | 7 |
| Phase 1b - Arm 2 DSP-7888 Dosing Emulsion in combination with Pembrolizumab
DSP-7888 Dosing Emulsion: DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm.
Pembrolizumab: Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study. | 9 |
| Phase 2 - Ombipepimut-S + Pembrolizumab The Phase 2 dose of ombipepimut-S Dosing Emulsion will be the recommended dose as determined in the Phase 1b Arm 2 part of the study. | 31 |
| Total | 47 |
Baseline characteristics
| Characteristic | Phase 1b - Arm 1 | Phase 1b - Arm 2 | Phase 2 - Ombipepimut-S + Pembrolizumab | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 18 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 5 Participants | 13 Participants | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 8 Participants | 27 Participants | 42 Participants |
| Region of Enrollment United States | 7 participants | 9 participants | 31 participants | 47 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 31 Participants | 37 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 0 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 7 | 0 / 9 | 1 / 31 |
| other Total, other adverse events | 7 / 7 | 9 / 9 | 31 / 31 |
| serious Total, serious adverse events | 3 / 7 | 5 / 9 | 8 / 31 |
Outcome results
Primary
Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs).
The RP2D was based on the data collected during phase 1b.
Time frame: 28 days
Population: Only data from arm 2 of phase 1b were analyzed to determine the RP2D.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b - Arm 1 | Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs). | 10.5 mg |
Primary
Number of Patients With Adverse Events and Serious Adverse Events
Time frame: From the date of signing informed consent until 30 days after last dose for an average of 3 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1b - Arm 1 | Number of Patients With Adverse Events and Serious Adverse Events | 7 Participants |
| Phase 1b - Arm 2 | Number of Patients With Adverse Events and Serious Adverse Events | 9 Participants |
| Phase 2 - Ombipepimut-S + Pembrolizumab | Number of Patients With Adverse Events and Serious Adverse Events | 31 Participants |
Primary
Phase II: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab in Patients With Platinum-resistant Ovarian Cancer (PROC).
Defined as the proportion of patients who have achieved confirmed Complete Response or Partial Response by RECIST v1.1 based on investigator assessment.
Time frame: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months
Population: Sponsor's decision to terminate the study, hence data for determination of ORR were not collected.
Secondary
Phase Ib: Assessment of the Duration of Response (DOR) of Ombipepimut-S in Combination With Nivolumab or Pembrolizumab
DOR is defined as the time from first documentation of response until the time of first documentation of disease progression by RECIST v1.1 and iRECIST or death by any cause.
Time frame: At week 4 for patients on the nivolumab arm and week 6 for patients on the pembrolizumab arm. Thereafter weeks 12, 18 and 24 and every 12 weeks until progression or death.
Population: Sponsor's decision to terminate study. Therefore no data were collected nor analyzed.
Secondary
Phase Ib: Percentage of Patients With Overall Survival (OS) When Treated With Ombipepimut-S in Combination With Nivolumab or Pembrolizumab
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1b - Arm 1 | Phase Ib: Percentage of Patients With Overall Survival (OS) When Treated With Ombipepimut-S in Combination With Nivolumab or Pembrolizumab | 0 percentage of participants |
| Phase 1b - Arm 2 | Phase Ib: Percentage of Patients With Overall Survival (OS) When Treated With Ombipepimut-S in Combination With Nivolumab or Pembrolizumab | 0 percentage of participants |
Secondary
Phase Ib: Progression-free Survival (PFS) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab
The percentage of participants with a complete response or partial response who have measurable disease at baseline imaging.
Time frame: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months
Population: Sponsor's decision to terminate study. No data were collected and analyzed.
Secondary
Phase Ib: The 6-month Progression-free Survival (PFS) Rate of Ombipepimut-S in Combination With Nivolumab or Pembrolizumab
Defined as the proportion of patients who neither progressed by RECIST (v.1.1) nor died before 6 months (24 weeks) from the first study treatment
Time frame: 6 months
Population: Sponsor's decision to terminate study. No data were collected or analyzed.
Secondary
Phase Ib: The Disease Control Rate (DCR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab
Defined as the percentage of patients who have achieved best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1 and iRECIST.
Time frame: At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion
Population: Sponsor's decision to terminate study. No data were collected and analyzed.
Secondary
Phase Ib: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab or Nivolumab
Defined as the proportion of patients who have achieved confirmed complete response (CR) or partial response (PR) evaluated using RECIST v1.1 and iRECIST.
Time frame: At 4 weeks for the nivolumab arm and at 6 weeks for the pembrolizumab arm and then at Weeks 12, 18, and 24 after the first dose of the DSP-7888 dosing emulsion
Population: Sponsor's decision to terminate study. No data were collected and analyzed.
Secondary
Phase II: 6-month Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab
PFS is defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST (v.1.1), or death by any cause
Time frame: 6 months
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.
Secondary
Phase II: Assessment of the Duration of Response (DOR) of Ombipepimut-S in Combination With Pembrolizumab
Defined as the time from the first documentation of a response (CR or PR) until time of first documentation of disease progression by RECIST v1.1 or death by any cause.
Time frame: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression up to 24 months.
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.
Secondary
Phase II: Assessment of the Progression-free Survival (PFS) of Ombipepimut-S in Combination With Pembrolizumab
Defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by RECIST v.1.1, or death by any cause
Time frame: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.
Secondary
Phase II: Disease Control Rate of Ombipepimut-S in Combination With Pembrolizumab
Defined as the percentage of patients who have achieved best overall response (BOR) of complete response, partial response, or stable disease per RECIST (v.1.1)
Time frame: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression, up to 24 months.
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.
Secondary
Phase II: Evaluation of the Safety and Tolerability of Ombipepimut-S in Combination With Pembrolizumab
Demonstrated by the number of participants with adverse events and serious adverse events
Time frame: Up to 24 months
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.
Secondary
Phase II: Immune Disease Control Rate (iDCR) of Ombipepimut-S in Combination With Pembrolizumab
Defined as the percentage of patients who have achieved best overall response of iCR, iPR, or immune stable disease (iSD), per iRECIST
Time frame: Up to 24 months
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.
Secondary
Phase II: Immune Duration of Response (iDOR) of Ombipepimut-S in Combination With Pembrolizumab
Defined as the time from the first documentation of response (iCR or iPR) until time of first documentation of disease progression by iRECIST, or death by any cause
Time frame: Up to 24 months
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.
Secondary
Phase II: Immune Objective Response Rate (iORR) of Ombipepimut-S in Combination With Pembrolizumab
Defined as the percentage of patients who have achieved confirmed immune complete response (iCR) or immune partial response (iPR), evaluated using iRECIST based on investigator's assessment.
Time frame: Up to 24 months
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.
Secondary
Phase II: Immune Progression-free Survival (iPFS) of Ombipepimut-S in Combination With Pembrolizumab
Defined as the time from the date of the first dose of study treatment to the earlier date of assessment of progression by iRECIST or death by any cause
Time frame: Up to 24 months
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.
Secondary
Phase II: Overall Survival of Patients Treated With Ombipepimut-S in Combination With Pembrolizumab
Defined as the time from the date of first dose of study treatment to the date of death by any cause
Time frame: Every 3 months from last dose of study treatment up to 24 months.
Population: Sponsor's decision to terminate the study. Hence data were not collected nor analyzed.