Clinical Trial 17974

Cancer Type: Cutaneous
Interventions:BMS-936558 (Nivolumab); Ipilimumab; Nivolumab; RTA 408; Yervoy (Ipilimumab)

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Joseph Markowitz

Overview

Study Title

An Open-Label, Multicenter, Dose-Escalation, Phase 1b/2 Study of the Safety, Efficacy, Pharmacodynamics, and Pharmacokinetics of RTA 408 in Combination With Ipilimumab or Nivolumab in the Treatment of Patients With Unresectable or Metastatic Melanoma

Summary

This research study has 3 purposes: To see if the RTA 408 pills are safe and well tolerated in participants with melanoma who are also taking ipilimumab or nivolumab IV therapy; To see if the RTA 408 pills and ipilimumab or nivolumab IV therapy, when given together, are effective against melanoma; To test how the RTA 408 pills and ipilimumab or nivolumab IV therapy, when given together, affect participants¿ blood cells and tumor cells.

Objective

Objectives: Primary: To determine the safety of RTA 408 in combination with ipilimumab or nivolumab To evaluate the efficacy of the Phase 2 dose of RTA 408 in combination with ipilimumab or nivolumab using overall response rate (ORR; complete plus partial responses) Exploratory: To assess the biological activity of RTA 408 in combination with ipilimumabor nivolumab in peripheral blood mononuclear cells (PBMCs) To assess the biological activity of RTA 408 in combination with ipilimumabor nivolumab in tumor biopsies To assess time-to-event outcomes of patients treated with RTA 408 in combination with ipilimumab or nivolumab

Inclusion Criteria

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  • ≥18 years of age;
  • Have advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
  • Eligible for commercial receipt of therapy to be used in this study in combination with RTA 408 (i.e., ipilimumab or nivolumab);
  • Have discontinued previous treatments for cancer;
  • Have discontinued previous experimental therapies and checkpoint inhibitor antibodies at least 28 days prior to the Randomization Visit;
  • Able to swallow capsules.

  • Exclusion Criteria

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  • Have received prior treatment with therapy to be used in this study in combination with RTA 408 (i.e., ipilimumab or nivolumab) if enrolling in the Phase 2 portion of the study. This criterion does not apply to participants enrolling in the Phase 1b portion of the study.
  • Have prior malignancy active within the previous 2 years;
  • Have any active autoimmune disease or a history of known or suspected autoimmune disease;
  • History of brain metastases that meet certain conditions;
  • History of specific cardiovascular abnormalities;
  • Have known active fungal, bacterial, and/or viral infection, including human immunodeficiency virus (HIV) or hepatitis virus (A,B, or C).