PROTOCOL: Alliance-A031704

SCHEMA A031704

Please Note: Below is partial eligibility, for full eligibility requirement’s,  please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

ELIGIBILITY:

Histologic Documentation: Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features.  Stage: Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable.

1. Must be intermediate or poor risk patient per IMDC criteria (1 or more of the following: KPS<80, <1 year from diagnosis (including initial nephrectomy) to systemic treatment for metastatic disease, hemoglobin less than LLN, corrected calcium concentration greater than ULN, absolute neutrophil count greater than ULN, platelet count>ULN).
2. Measurable disease.
3. Karnofsky performance status 70%
4. No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab, tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting Tcell co-stimulation or checkpoint pathways. The only exception is for prior treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or post-operative trials, as long as >1 year since completion of systemic therapy.  No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 (>28 days) prior adjuvant sunitinib >180 days since completion and prior immunotherapy as above are allowed).  No cancer therapy less than 28 days prior to registration; this includes radiation therapy, except for bone lesions less than 14 days prior to registration. There must be a complete recovery and no ongoing complications from radiotherapy.