Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biogen
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Be ≥18 years of age;
2. Have advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma;
3. 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);
4. Have discontinued previous treatments for cancer;
5. Have discontinued previous experimental therapies and checkpoint inhibitor antibodies at least 28 days prior to the Randomization Visit
You may not be if
1. 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.
2. Have prior malignancy active within the previous 2 years;
3. Have any active autoimmune disease or a history of known or suspected autoimmune disease;
4. History of brain metastases that meet certain conditions;
5. History of specific cardiovascular abnormalities;
6. Have known active fungal, bacterial, and/or viral infection, including human immunodeficiency virus (HIV) or hepatitis virus (A,B, or C).
