A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors
Stopped early · Phase 1/Phase 2
Conditions studied: Renal Cell Carcinoma (RCC), Urothelial Carcinoma, Primary Peritoneal Cancer, Platinum-resistant Ovarian Cancer (PROC), Serous Epithelial Ovarian Cancer, Fallopian Tube Cancer
In brief
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.
Key facts
- Study ID
- NCT03311334
- Run by
- Sumitomo Pharma America, Inc.
- People needed
- 47
- Starts
- 2017-12-14
- Expected to finish
- 2022-11-29
- Last updated by the study team
- 2024-04-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
- Cedars-Sinai Medical Center — Los Angeles, California, United States
- UC San Francisco Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
- Rocky Mountain Cancer Centers — Aurora, Colorado, United States
- AdventHealth Cancer Institute — Orlando, Florida, United States
- Decatur Memorial Hospital — Decatur, Illinois, United States
- Horizon Oncology Research — Lafayette, Indiana, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- St Vincent Frontier Cancer Center — Billings, Montana, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- UC Health, LLC — Cincinnati, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- West Cancer Clinic — Germantown, Tennessee, United States
- Mary Crowley Cancer Research — Dallas, Texas, United States
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Seattle Cancer Care Alliance — Seattle, Washington, United States
- Summit Cancer Centers — Spokane, Washington, United States
- Centre hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada
- SMBD Jewish General Hospital — Montreal, Quebec, Canada
Full record on ClinicalTrials.gov
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