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

Conditions

• Renal Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Tivozanib — DRUG
  Tivozanib will be administered orally.
• Nivolumab — DRUG
  Nivolumab will be administered via intravenous infusion.

Study Details

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).

Key Dates

Start date

Sep 9, 2021

Status verified

May 2026

Primary completion

Jan 20, 2026

Completion

Jan 20, 2026

Study Design

Enrollment

343 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tivozanib in Combination with Nivolumab
  Subjects with advanced RCC will receive 0.89 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug and nivolumab every 4 weeks on Day 1 of each Cycle, until disease progression or unacceptable toxicities occur, other withdrawal criteria are met, or completion of 2 years of treatment \[for nivolumab\] whichever occurs first.
• Experimental: Tivozanib
  Subjects with advanced RCC will receive 1.34 mg of tivozanib once daily (QD) for 3 weeks followed by 1 week off study drug until disease progression or unacceptable toxicities occur, or other withdrawal criteria are met.

Primary Outcome Measure

Progression free survival [ Time Frame: Until progressive disease [PD] (Approximately 30 months) ]

Locations (36)

Related coverage on Hipa.ai

• Nivolumab Phase 3 Trial in Renal Cell Carcinoma Completes Primary Study
  Nivolumab · Jan 20, 2026 · ClinicalTrials.gov
• Nivolumab Phase 3 Trial for Renal Cell Carcinoma Reaches Primary Completion
  Nivolumab · Sep 30, 2025 · ClinicalTrials.gov

Find similar trials in Duarte, CA

Related Studies

• Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Renal and Other Urologic Malignant Disorders
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
  Enrolling By Invitation · National Institutes of Health Clinical Center (CC) · Bethesda, Maryland
• A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
  Recruiting · Beth Israel Deaconess Medical Center · Boston, Massachusetts
• A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)
  PHASE3 · Recruiting · Xynomic Pharmaceuticals, Inc. · Phoenix, Arizona