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Alliance A031704

Trial

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

January 27, 2020

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

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Wednesday, January 27, 2021 12:56:56 PM