Clinical Trial Information

Schema A031704

PROTOCOL: Alliance-A031704

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

1.  Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid features.
   1. Stage: Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable.
2. Measurable disease.
3. Intermediate or poor risk patients. 1 or more of the following: KPS<80, <1 year from diagnosis to systemic treatment, hemoglobin less
   than LLN, corrected calcium concentration greater than ULN, absolute neutrophil count greater than ULN, platelet count>ULN.
4. CNS disease permitted, if stable and not otherwise causing symptoms or needing active treatment.
5. Karnofsky performance status 70%.
6. 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 T-cell co-stimulation or checkpoint pathways.
7. No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 (>28 days) and prior adjuvant sunitinib >180 days since completion are allowed).
8. 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.
9. Age ≥ 18 years.