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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%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; average of 1 year

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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

~4750

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,426 Total Patients Enrolled

AVEO Pharmaceuticals, Inc.Industry Sponsor

45 Previous Clinical Trials

3,902 Total Patients Enrolled

Eric Jonasch, M DPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings left for participants in this research endeavor?

"Clinicaltrials.gov suggests that this medical trial is no longer recruiting patients, as the initial post date was January 31st 2024 and last updated on September 19th 2023. However, there are 2,682 other active clinical trials in need of participants at present."

Answered by AI

Has the Federal Drug Administration given their stamp of approval to Tivozanib and Nivolumab in tandem?

"As this is a phase 2 trial, which contains minimal efficacy data but some safety information, our team has assigned the medication combination of Tivozanib and Nivolumab with score of two."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma

2024. "Phase 2 Study of Combination Tivozanib and Nivolumab in Advanced Non-Clear Cell Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06053658.