CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 701 enrolled
Drug / intervention
Nivolumab +3 morebiological
Likely dose
Nivolumab + Cabozantinib (specific doses not provided in eligibility criteria or arms section)AI-extracted
Key inclusion· 3
  • ✓Histologically confirmed RCC with clear-cell component, including sarcomatoid variants
  • ✓Advanced (surgically/radiologically unresectable) or metastatic (AJCC Stage IV) disease
  • ✓No prior systemic therapy for RCC, except one prior adjuvant/neoadjuvant therapy if non-VEGF-targeting and recurrence ≥6 months post-therapy
Key exclusion· 4
  • ✕Active CNS metastases
  • ✕Active, known, or suspected autoimmune disease
  • ✕Systemic corticosteroids >10 mg/day prednisone equivalent or other immunosuppressive medications within 14 days of randomization
  • ✕Live/attenuated vaccine within 30 days of first treatment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03141177
NCT03141177Phase 3Active
CompareCT.gov

A Phase 3, Randomized, Open-Label Study of Nivolumab Combined With Cabozantinib Versus Sunitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Bristol-Myers Squibb·interventional·Posted May 4, 2017·Updated Jun 6, 2025

In Brief

A Phase 3 clinical trial evaluating Nivolumab, Cabozantinib, and 2 other interventions for Renal Cell Carcinoma. Active but no longer recruiting, targeting 701 participants across 135 sites in 18 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Cell Carcinoma
CountriesArgentina, Australia, Brazil, Chile, Czechia, Germany, Greece, Israel, Italy, Japan, Mexico, Poland, Romania, Russia, Spain, Turkey (Türkiye), United Kingdom, United States
CollaboratorsExelixis, Ono Pharmaceutical Co., Ltd.

Timeline

Phase 3ActiveOverdue
201820192020202120222023202420252026
First PostedMay 4, 2017
Enrollment StartJul 23, 2017
Primary CompletionFeb 12, 2020
Study CompletionJan 16, 2026
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.2 years ago

Interventions

Nivolumabbiological

Specified dose on specified day

Cabozantinibdrug

Specified dose on specified days

Sunitinibdrug

Specified dose on specified days.

Ipilimumabbiological

Specified dose on specified days