Nivolumab + Ipilimumab for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen byNizar Tannir

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well nivolumab and ipilimumab work in treating patients with kidney cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Research Team

Nizar Tannir

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with kidney cancer, specifically Renal Medullary Carcinoma. Participants can be new to treatment or have had previous therapies, must not be HIV positive or pregnant, and should not have other severe medical conditions. They need a good performance status (able to carry out daily activities) and acceptable blood test results.

Inclusion Criteria

Your blood clotting tests should not be more than 1.5 times higher than the normal range before joining the study.

Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements

Your blood must have enough white blood cells called neutrophils.

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Exclusion Criteria

Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study

Patients must not be scheduled to receive another experimental drug while on this study

I have not had major surgery or significant injury in the last 4 weeks.

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Treatment Details

Interventions

Nivolumab and Ipilimumab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing the combination of two immunotherapy drugs: Nivolumab and Ipilimumab. These drugs are designed to help the immune system recognize and fight cancer cells in patients with advanced kidney cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab, ipilimumab)Experimental Treatment2 Interventions

Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.