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)
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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