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

Official Title

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

Summary:

This is a Phase 1b/2, open-label, multicentre study of DSP-7888 Dosing Emulsion in combination with checkpoint inhibitors (nivolumab or pembrolizumab) in adult patients with solid tumours, 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 antitumour 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-tumour activities, but the total sample size will not exceed 60 patients. This brings the total maximum study population to approximately 84 patients.

Trial Description

Primary Outcome:

  • Phase Ib: Determination of the safety and tolerability of DSP-7888 Dosing Emulsion given intradermally with a checkpoint inhibitor (Nivolumab or Pembrolizumab) in adult patients with advanced solid tumours by assessing dose-limiting toxicities (DLTs).
  • Phase Ib: Determination of the Recommended Phase 2 Dose (RP2D) by assessing dose-limiting toxicities (DLTs).
  • Phase II: Evaluation of the preliminary antitumour activity of DSP-7888 Dosing Emulsion administered with pembrolizumab in terms of Objective Response Rate (ORR) in patients with platinum-resistant ovarian cancer (PROC).
Secondary Outcome:
  • Phase Ib: Objective response rate (ORR)
  • Phase Ib: Disease control rate (DCR)
  • Phase Ib: Duration of response (DOR)
  • Phase Ib: Progression-free survival (PFS)
  • Phase Ib: 6-month PFS
  • Phase Ib: Overall survival (OS)
  • Phase II: DOR
  • Phase II: DCR
  • Phase II: PFS
  • Phase II: 6-month PFS
  • Phase II: OS
  • Phase II: Immune objective response rate (iORR)
  • Phase II: Immune disease control rate (iDCR)
  • Phase II: Immune progression-free survival (iPFS)
  • Phase II: immune DOR (iDOR)
  • Phase II: Evaluation of the safety and tolerability of DSP-7888 Dosing Emulsion administered with pembrolizumab.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society