A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors
- Conditions
- Renal Cell Carcinoma (RCC)Urothelial CarcinomaPrimary Peritoneal CancerSerous Epithelial Ovarian CancerFallopian Tube CancerPlatinum-resistant Ovarian Cancer (PROC)
- Interventions
- Registration Number
- NCT03311334
- Lead Sponsor
- Sumitomo Pharma America, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DSP-7888 Dosing Emulsion in combination with Nivolumab DSP-7888 Dosing Emulsion - DSP-7888 Dosing Emulsion in combination with Pembrolizumab DSP-7888 Dosing Emulsion - DSP-7888 Dosing Emulsion in combination with Nivolumab Nivolumab - DSP-7888 Dosing Emulsion in combination with Pembrolizumab Pembrolizumab -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
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: 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: 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 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 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 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: 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: 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
Trial Locations
- Locations (19)
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Seattle Cancer Care Alliance
🇺🇸Seattle, Washington, United States
UC San Francisco Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
UC Health, LLC
🇺🇸Cincinnati, Ohio, United States
Horizon Oncology Research
🇺🇸Lafayette, Indiana, United States
Norton Cancer Institute
🇺🇸Louisville, Kentucky, United States
AdventHealth Cancer Institute
🇺🇸Orlando, Florida, United States
Centre hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montréal, Quebec, Canada
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Rocky Mountain Cancer Centers
🇺🇸Aurora, Colorado, United States
SMBD Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
St Vincent Frontier Cancer Center
🇺🇸Billings, Montana, United States
Summit Cancer Centers
🇺🇸Spokane, Washington, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
West Cancer Clinic
🇺🇸Germantown, Tennessee, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States