NCT03311334

A Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors in Adult Patients With Advanced Solid Tumors

A Phase 1b/2, Multicenter, Open-Label Study of DSP-7888 Dosing Emulsion in Combination With Immune Checkpoint Inhibitors Nivolumab or Pembrolizumab in Adult Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Cell Carcinoma (RCC)
• Urothelial Carcinoma
• Primary Peritoneal Cancer
• Platinum-resistant Ovarian Cancer (PROC)
• Serous Epithelial Ovarian Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	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.
DRUG	Nivolumab	Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
DRUG	Pembrolizumab	Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.

Timeline

• Start date: 2017-12-14
• Primary completion: 2022-10-19
• Completion: 2022-11-29
• First posted: 2017-10-17
• Last updated: 2024-04-18
• Results posted: 2024-04-18

Locations

19 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study