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Study to Compare Tivozanib in Combination With Nivolumab to Tivozanib Monotherapy in Subjects With Renal Cell Carcinoma

NCT04987203 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2026-05-08

No results posted yet for this study

Summary

This study will be comparing tivozanib in combination with nivolumab to tivozanib alone in subjects with advanced Renal Cell Carcinoma (RCC) who have had 1 or 2 prior lines of therapy, one of which was an Immune Checkpoint Inhibitor (ICI).

Conditions

Interventions

DRUG

Tivozanib

Tivozanib will be administered orally.

DRUG

Nivolumab

Nivolumab will be administered via intravenous infusion.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • AVEO Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-09
Primary Completion
2026-01-20
Completion
2026-01-20
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Chile
  • Czechia
  • France
  • Germany
  • Italy
  • Mexico
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT04987203 on ClinicalTrials.gov