The REVEAL Trial is a clinical research trial targeting the Melanoma patient population.
- Duke Cancer Institute
- Not yet recruiting
- Durham, North Carolina, United States, 27710
Principal Investigator: April Salama, MD
Please complete the information request form and you will be contacted once the investigational site is open to recruiting.
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|Study Design:||Allocation: Non-Randomized |
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official 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 in the Treatment of Patients With Unresectable or Metastatic Melanoma|
|Ages Eligible for Study:||18 Years and older|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Be ≥18 years of age;
- Have advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
- Have received no prior treatment with ipilimumab;
- Have discontinued previous treatments for cancer;
- Have discontinued previous experimental therapies for a minimum of 28 days;
- Be able to swallow capsules.
- 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).