Study on Nivolumab and Cabozantinib Compared to Sunitinib for Untreated Advanced or Metastatic Kidney Cancer

Sponsor: Bristol-Myers Squibb

Sponsor score: 60

ClinicalTrials ID:NCT03141177

This clinical trial is testing whether a combination of the drugs Nivolumab and Cabozantinib is safe and effective compared to Sunitinib for patients with advanced or metastatic kidney cancer who have not received prior treatment.

Patient Parameters

Program Overview

The goal of this study is to find out if using Nivolumab together with Cabozantinib is a safe and effective treatment option compared to Sunitinib for patients with advanced or metastatic kidney cancer that has not been treated before.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of renal cell carcinoma (RCC) with clear-cell features, which may also include sarcomatoid features.
  • Have advanced kidney cancer that cannot be treated with surgery or radiation, or cancer that has spread to other parts of the body (Stage IV).
  • Have not received any prior systemic treatment for kidney cancer, except if you had one previous treatment after surgery that did not include drugs targeting VEGF or its receptors, and if the cancer returned at least 6 months after the last dose of that treatment.

Exclusion Criteria

  • Have active cancer that has spread to the brain or central nervous system.
  • Have any active or suspected autoimmune disease.
  • Require treatment with corticosteroids (more than 10 mg of prednisone daily) or other immunosuppressive drugs within 14 days before starting the study.
  • Have received a live vaccine within 30 days before starting the study.

Other specific criteria may apply.

Locations

FACILITYZIPCITYSTATE
Local Institution - 007736526DaphneAlabama
Local Institution - 004485338GoodyearArizona
Local Institution - 013285724-5024TucsonArizona
Local Institution - 013393309BakersfieldCalifornia
Local Institution - 009390404Los AngelesCalifornia
Local Institution - 009090277Redondo BeachCalifornia
Local Institution - 008893401San Luis ObispoCalifornia
Central Coast Medical Oncology Corporation93454Santa MariaCalifornia
Local Institution - 010380045AuroraColorado
Local Institution - 012730607AthensGeorgia

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