Tivozanib + Nivolumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

+189 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AVEO Pharmaceuticals, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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).

Eligibility Criteria

This trial is for adults with advanced kidney cancer who've had 1 or 2 previous treatments, including an immune therapy. They must have clear cell renal carcinoma, measurable disease, be in good physical condition (able to perform daily activities), and use contraception. Excluded are those with active autoimmune diseases, uncontrolled high blood pressure, more than one prior immune therapy in the metastatic setting, severe past reactions to immune therapies, certain treatment sequences or over two lines of prior therapy.

Inclusion Criteria

I have recovered from previous treatment side effects to my normal or mild condition.

My kidney cancer has been confirmed with a lab test.

You have a measurable disease according to specific medical guidelines.

+3 more

Exclusion Criteria

I've had a TKI as my first treatment and an ICI as my second for advanced cancer.

My high blood pressure is not under control.

I have an active autoimmune disease or stopped IO therapy due to side effects.

+4 more

Participant Groups

The study compares a combination of Tivozanib (a drug that targets tumor blood vessels) and Nivolumab (an immunotherapy) versus just Tivozanib alone in patients with advanced Renal Cell Carcinoma. It aims to see if adding Nivolumab improves outcomes for patients who have already tried other treatments.

2Treatment groups

Experimental Treatment

Group I: Tivozanib in Combination with NivolumabExperimental Treatment2 Interventions

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.

Group II: TivozanibExperimental Treatment1 Intervention

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.

Nivolumab is already approved in United States, European Union, Canada, Switzerland for the following indications:

🇺🇸 Approved in United States as Opdivo for: