Alliance A031704

Clinical Trial Title PD-inhibitor (Nivolumab) and Ipilimumab followed by nivolumab vs. VEGF TKI cabozantinib with nivolumab in metastatic untreated Renal Cell Cancer
Trial Status Open to Enrollment
Start Date 01/27/2020
Location Doctors & Locations
Trial Type Cancer - Adult Oncology
Specific Condition Kidney Cancer
Description This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cabozantinib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.
Eligibility Criteria

Eligibility Criteria

  • 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 per RECIST 1.1.
  • CNS disease permitted, if stable and not otherwise causing symptoms or needing active treatment
  • Karnofsky performance status ≥ 70%
  • No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents
  • No prior previous systemic therapy for renal cell carcinoma
  • Age ≥ 18 years
IRB Number Central IRB
Notes https://clinicaltrials.gov/ct2/show/NCT03793166?term=a031704
Principal Investigator Jacqueline Vuky, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org