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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• DSP-7888 Dosing Emulsion — DRUG
  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 — DRUG
  Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
• Pembrolizumab — DRUG
  Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.

Study Details

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 Dates

Start date

Dec 14, 2017

Status verified

Mar 2024

Primary completion

Oct 19, 2022

Completion

Nov 29, 2022

Study Design

Enrollment

47 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: DSP-7888 Dosing Emulsion in combination with Nivolumab
• Experimental: DSP-7888 Dosing Emulsion in combination with Pembrolizumab

Primary Outcome Measure

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. ]

Locations (17)

Find similar trials in Tucson, AZ

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