Phase II study of front line therapy with nivolumab and salvage nivolumab + ipilimumab in patients with advanced renal cell carcinoma
This research study is a phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether the intervention works in treating a specific disease. “Investigational” means that the intervention is being studied. The Food and Drug Administration (FDA) has approved Nivolumab as treatment for advanced renal cell carcinoma, however discontinuation of nivolumab and the combination with Ipilimumab are investigational. Nivolumab is an antibody (type of human protein) drug that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is also an antibody that may stimulate your body’s immune system to fight tumor cells. Ipilimumab is FDA approved for the treatment of melanoma (skin cancer) and has been previously studied in renal cell cancer. Specifically, this study will look at the use of these treatments based on how your disease responds to the treatment. Both of these study drugs are given by IV (intravenous), through a vein.
Are you Eligible? (Inclusion Criteria)
- Inclusion Criteria-Part A
- Subject must meet all of the following applicable inclusion criteria to
- participate in this study:
- 1. Patients must have histologically confirmed advanced Renal cell Cacinoma
- (RCC) (any histology). Collecting duct tumors and tumors originating from
- the renal pelvis or upper urinary tract are considered of urothelial origin
- and are excluded from this protocol.
- 2. Patients must have at least one measurable site of disease that has not
- been had previous radiation to the marker lesion(s), or there must be
- evidence of progression since the radiation.
- 3. ECOG performance status 0-2
- 4. Age ≥ 18 years
- 5. Have signed the current approved informed consent form