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Melanotan-2

MT-II, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2

Quick Stats
Studies 3
Trials 100
Terminated PHASE1, PHASE2 INTERVENTIONAL NCT03311334

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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

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

Primary Outcomes

Measure: Number of Patients With Adverse Events and Serious Adverse Events
TimeFrame: From the date of signing informed consent until 30 days after last dose for an average of 3 months.
Description:
Measure: Determination of the Recommended Phase 2 Dose (RP2D) by Assessing Dose-limiting Toxicities (DLTs).
TimeFrame: 28 days
Description: The RP2D was based on the data collected during phase 1b.
Measure: Phase II: The Objective Response Rate (ORR) of DSP-7888 Dosing Emulsion Administered With Pembrolizumab in Patients With Platinum-resistant Ovarian Cancer (PROC).
TimeFrame: Radiographic imaging every 6 weeks for 24 weeks and then every 12 weeks until progression for an average of 12 months
Description: Defined as the proportion of patients who have achieved confirmed Complete Response or Partial Response by RECIST v1.1 based on investigator assessment.

Trial Information

NCT ID

NCT03311334

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

Sumitomo Pharma America, Inc.

Last Updated

December 15, 2025