April 9, 2020 Renal

Clinical Trial Information

PROTOCOL: Alliance-A031704

SCHEMA A031704

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


  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.

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