NCT03333616

Who might be able to join this trial:

• You are 18 years of age or older at the time you give consent.
• You are in reasonably good general health and able to carry out some daily activities (confirm with trial site regarding how this is measured).
• You have been diagnosed with one of the following cancers that cannot be surgically removed and has spread: a specific type of adrenal cancer (ACC), a non-standard type of bladder or upper urinary tract cancer, a non-standard type of prostate cancer, penile cancer, a germ-cell tumor that has not responded to treatment, or a high-grade neuroendocrine or small cell cancer of the urinary or reproductive system — note: at this time, only the bladder and neuroendocrine groups are currently open to new participants.
• You have tumor tissue samples available from a previous biopsy (stored in a specific way), and you are willing and able to have a fresh tumor biopsy taken before treatment starts, unless your doctor determines it is not safe or possible.
• Your cancer can be measured on a scan to track whether treatment is working.
• Your blood test results show that your blood cells, kidneys, liver, and blood clotting are all working at an acceptable level, tested within 28 days before starting the study.
• If you are a woman who could become pregnant, you have had a negative pregnancy test within 28 days before joining the study.
• If you are a woman who could become pregnant, or a man, you agree to use two effective forms of contraception (or abstain from heterosexual sex) from the time you sign consent until 120 days after finishing treatment.
• You are able to understand and follow the study procedures for the full length of the study, as judged by your doctor.

Who may not be able to join:

• You have previously been treated with certain immune checkpoint drugs (such as PD-1, PD-L1, or CTLA-4 blocking medicines) for the type of cancer you are entering the trial for.
• You have taken strong immune-suppressing medicines (such as prednisone at higher doses, cyclosporine, methotrexate, or similar drugs) within 2 weeks before the first study dose — though low-dose or inhaled/topical versions may be allowed in some cases (confirm with trial site).
• You have received chemotherapy, hormone therapy, or another experimental treatment within 3 weeks before the first study dose — with some specific exceptions depending on your cancer type (confirm with trial site).
• You have had radiation therapy within 14 days before starting the study, unless it was a single treatment given just to relieve symptoms.
• You have active cancer that has spread to the brain, spinal cord, or the lining around the brain or spinal cord — unless it was already treated and you have been stable for at least 2 weeks before starting the study.
• You have had another type of cancer within the past 5 years, with some exceptions for certain low-risk or previously cured cancers (confirm with trial site).
• You have had a severe allergic reaction in the past to certain types of laboratory-made antibody medicines.
• You have a known allergy to any ingredient in the study drugs nivolumab or ipilimumab.
• You have an active or recent (within 6 months) autoimmune disease that requires significant immune-suppressing treatment — though some milder conditions like vitiligo or controlled thyroid disease may be allowed (confirm with trial site).
• You currently need high-dose steroid or immune-suppressing medicines within 14 days of starting the study.
• You have uncontrolled adrenal gland insufficiency (a condition where the adrenal glands do not produce enough hormones).
• You have a history of certain serious lung conditions, such as pulmonary fibrosis or drug-related lung inflammation, or signs of active lung inflammation on a recent chest scan.
• You are known to be HIV positive or have AIDS.
• You have an active hepatitis B infection (certain past infections that have resolved may be acceptable — confirm with trial site).
• You have an active hepatitis C infection (a past infection that is no longer detectable in the blood may be acceptable — confirm with trial site).
• You have taken antibiotic medicines by mouth or through a drip within 2 weeks before starting the study (routine antibiotics before a dental procedure are generally acceptable).
• You have an active infection