A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Running, not enrolling · Phase 3

Conditions studied: Renal Cell Carcinoma

In brief

The purpose of this study is to determine whether Nivolumab Combined with Cabozantinib is safe and effective compared to Sunitinib in previously untreated advanced or metastatic renal cell carcinoma

Key facts

Study ID

NCT03141177

Run by

Bristol-Myers Squibb

People needed

701

Starts

2017-07-23

Expected to finish

2026-01-16

Last updated by the study team

2025-06-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histological confirmation of RCC with a clear-cell component, including participants who may also have sarcomatoid features
• Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC
• No prior systemic therapy for RCC with the following exception:
• i) One prior adjuvant or neoadjuvant therapy for completely resectable RCC if such therapy did not include an agent that targets VEGF or VEGF receptors and if recurrence occurred at least 6 months after the last dose of adjuvant or neoadjuvant therapy

You may not qualify if…

• Any active CNS metastases
• Any active, known or suspected autoimmune disease
• Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
• Participants who have received a live/attenuated vaccine within 30 days of first treatment
• Other protocol defined inclusion/exclusion criteria could apply

Where it is running

• Local Institution - 0044 — Goodyear, Arizona, United States
• Local Institution - 0132 — Tucson, Arizona, United States
• Local Institution - 0133 — Bakersfield, California, United States
• Local Institution - 0093 — Los Angeles, California, United States
• Local Institution - 0090 — Redondo Beach, California, United States
• Local Institution - 0088 — San Luis Obispo, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• Local Institution - 0103 — Aurora, Colorado, United States
• Local Institution - 0127 — Athens, Georgia, United States
• Local Institution - 0086 — Newnan, Georgia, United States
• Local Institution - 0036 — Chicago, Illinois, United States
• Local Institution - 0042 — Zion, Illinois, United States
• Local Institution - 0091 — Fort Wayne, Indiana, United States
• Local Institution - 0087 — Wichita, Kansas, United States
• Local Institution - 0113 — Boston, Massachusetts, United States
• Local Institution - 0037 — Boston, Massachusetts, United States
• Local Institution - 0106 — Kansas City, Missouri, United States
• Local Institution - 0035 — St Louis, Missouri, United States
• Local Institution - 0102 — Las Vegas, Nevada, United States
• Local Institution - 0040 — Buffalo, New York, United States
• Local Institution - 0017 — New York, New York, United States
• Local Institution - 0067 — Portland, Oregon, United States
• Local Institution - 0135 — Allentown, Pennsylvania, United States
• Local Institution - 0105 — Nashville, Tennessee, United States
• Local Institution - 0077 — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.