April 9, 2020 Renal

Clinical Trial Information

SCHEMA

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.

Genesys Hurley Cancer Institute

302 Kensington Avenue
Flint, MI 48503

810-762-8226 | 888-762-8675

Ascension Genesys Hospital
Hurley Medical Center
Michigan Cancer Consortium

Newsletter

Ⓒ 2020 Genesys Hurley Cancer Institute | All Rights Reserved.