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Checkpoint Inhibitor

Tivozanib + Nivolumab for Advanced Kidney Cancer

Phase 2

Recruiting

Led By Eric Jonasch, M D

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Eastern Cooperative Oncology Group (ECOG) Appendix 1 performance status ≤2 (Karnofsky ≥60%)

Must not have

Prior nivolumab therapy

Current systemic corticosteroid use greater than prednisone 10 mg daily or equivalent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if two drugs combined can treat advanced kidney cancer.

Who is the study for?

Adults with advanced non-clear cell renal cell carcinoma, who have adequate organ function and no more than one prior systemic therapy. They must not be pregnant or breastfeeding, agree to use contraception, and cannot have uncontrolled hypertension or a history of severe allergic reactions to similar drugs.

What is being tested?

The trial is testing the combination of Tivozanib (a tyrosine kinase inhibitor) and Nivolumab (an immunotherapy agent) in patients with advanced kidney cancer that's not the usual 'clear cell' type. The goal is to see if this combo can control the disease better.

What are the potential side effects?

Possible side effects include high blood pressure, fatigue, nausea, liver enzyme changes, risk of infections due to immune system effects, and potential harm to an unborn child which is why contraception is required.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can care for myself but may not be able to do heavy physical work.

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My blood counts and liver/kidney functions are within normal ranges.

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I had hepatitis C but have been treated and cured, or I am currently being treated with an undetectable viral load.

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My hepatitis B virus is under control with treatment.

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I agree to use effective birth control during the study.

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My kidney cancer is not the clear cell type and has spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with nivolumab.

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I am taking more than 10 mg of prednisone or its equivalent daily.

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I am not pregnant or breastfeeding.

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My blood pressure is high despite taking two or more blood pressure medications.

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I am currently taking medication that affects liver enzyme levels.

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I am allergic to medications similar to tivozanib or nivolumab.

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I have previously been treated with tivozanib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Combination Tivozanib and NivolumabExperimental Treatment2 Interventions

Nivolumab by vein over about 60 minutes every 4 weeks (Day 1 of each cycle). Tivozanib tablets by mouth 1 time every day for 21 days (Days 1-21 of each cycle), and then no tablets on Days 22-28 of each cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tivozanib

2010

Completed Phase 3

~810

Nivolumab

2014

Completed Phase 3

~5220