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

NCT03141177 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 701

Last updated 2025-06-06

Study results available
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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

Conditions

Interventions

BIOLOGICAL

Nivolumab

Specified dose on specified day

DRUG

Cabozantinib

Specified dose on specified days

DRUG

Sunitinib

Specified dose on specified days.

BIOLOGICAL

Ipilimumab

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-23
Primary Completion
2020-02-12
Completion
2026-01-16
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Brazil
  • Chile
  • Czechia
  • Germany
  • Greece
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Romania
  • Russia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03141177 on ClinicalTrials.gov