Study on Nivolumab with or without Ipilimumab for Ovarian and Extra-renal Clear Cell Carcinomas

Inclusion Criteria

• Have a recurrent, advanced, or metastatic clear cell carcinoma of the ovary, fallopian tube, primary peritoneal, or extra-renal origin.
• Must provide a tissue sample from the cancer.
• Have at least one tumor that can be measured accurately by scans or exams.
• For ovarian, fallopian, or primary peritoneal cancer, must have tried at least one platinum and taxane-based chemotherapy that didn't work. For extra-renal clear cell cancer, must have tried at least one treatment for advanced disease.
• No previous treatment with anti-PD-1, PD-L1, or CTLA-4 antibodies.
• Be 18 years or older.
• Be in good overall health with an ECOG performance status of 0 or 1.
• Have normal organ and bone marrow function based on specific blood tests.
• Have adequate thyroid function.
• Have a resting oxygen level of at least 92%.
• Women of childbearing potential must use effective birth control and have a negative pregnancy test before starting the study.
• Men must use effective birth control if sexually active with women of childbearing potential.
• Be able to understand and sign a consent form.

Exclusion Criteria

• Have had previous treatment with Nivolumab or similar immune therapy drugs.
• Have had chemotherapy or radiation within the last 4 weeks (or 6 weeks for certain drugs) before starting the study.
• Have not recovered from significant side effects of previous treatments.
• Are taking other experimental drugs.
• Have known brain metastases.
• Have severe allergies to monoclonal antibodies.
• Have uncontrolled illnesses like infections, heart failure, or psychiatric conditions.
• Are pregnant or breastfeeding.
• Have had another invasive cancer within the last 3 years, except for certain skin cancers.
• Have received chemotherapy for another cancer in the last 3 years.
• Have HIV or AIDS unless on stable treatment with no detectable viral load.
• Have treated hepatitis B or C with no detectable viral load.
• Have active or history of autoimmune diseases that may require immune suppression.
• Require systemic steroids or immunosuppressive drugs within 14 days of starting the study.
• Have any other medical condition that may prevent safe participation.
• Plan to receive other cancer treatments during the study.
• Have significant nerve damage (Grade 2 or higher).