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Status:

COMPLETED

RTA 408 Capsules in Patients With Melanoma - REVEAL

Lead Sponsor:

Biogen

Conditions:

Melanoma

Unresectable (Stage III) Melanoma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief Summary

Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for approximately three-fourths of all skin cancer deaths. For metastatic or unresectable melanomas, standard tre...

Eligibility Criteria

Inclusion

  • Be ≥18 years of age;
  • Have advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
  • Be eligible for commercial receipt of therapy to be used in this study in combination with RTA 408 (i.e., ipilimumab or nivolumab in the Phase 1b portion and nivolumab only in the Phase 2 portion);
  • Have discontinued previous treatments for cancer;
  • Have discontinued previous experimental therapies and checkpoint inhibitor antibodies at least 28 days prior to the Randomization Visit

Exclusion

  • 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 patients 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).

Key Trial Info

Start Date :

October 31 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 23 2018

Estimated Enrollment :

41 Patients enrolled

Trial Details

Trial ID

NCT02259231

Start Date

October 31 2014

End Date

July 23 2018

Last Update

June 4 2025

Active Locations (10)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (10 locations)

1

Southern Cancer Center

Mobile, Alabama, United States, 36608

2

Highlands Oncology Group

Fayetteville, Arkansas, United States, 72703

3

University of Colorado Cancer Center, Anschutz Cancer Pavilion

Aurora, Colorado, United States, 80045

4

Christiana Hospital Helen F. Graham Cancer Center

Newark, Delaware, United States, 19713