Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma

Conditions

• Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cabozantinib — DRUG
  Specified dose on specified days.
• Nivolumab — BIOLOGICAL
  Specified dose on specified days.
• Ipilimumab — BIOLOGICAL
  Specified dose on specified days.
• Cabozantinib-matched placebo — DRUG
  Specified dose on specified days.

Study Details

This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.

Key Dates

Start date

Jun 25, 2019

Status verified

Aug 2025

Primary completion

Jan 31, 2022

Completion

Jan 31, 2027

Study Design

Enrollment

855 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Experimental Arm
  Cabozantinib + nivolumab + ipilimumab (4 doses) followed by cabozantinib + nivolumab
• Active Comparator: Control Arm
  Cabozantinib-matched placebo + nivolumab + ipilimumab (4 doses) followed by cabozantinib-matched placebo + nivolumab

Primary Outcome Measure

Duration of Progression-Free Survival (PFS) by Blinded Independent Radiology Committee (BIRC) [ Time Frame: Up to 32 months ]

Locations (30)

Related coverage on Hipa.ai

• Nivolumab Combination Trial Shows Improved PFS in Advanced Renal Cell Carcinoma
  Nivolumab · Sep 10, 2025 · ClinicalTrials.gov

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