Immunotherapy for Renal Medullary Carcinoma

Recruiting in Palo Alto (17 mi)

Pavlos Msaouel | MD Anderson Cancer Center

Overseen byPavlos Msaouel

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 trial is testing if a combination of two drugs, nivolumab and relatlimab, can help control a type of kidney cancer called renal medullary carcinoma that has spread or is hard to treat. These drugs work by helping the immune system recognize and attack cancer cells. The goal is to improve treatment outcomes. Nivolumab has been approved for the treatment of various cancers, including renal cell carcinoma, and is often used in combination therapies.

Eligibility Criteria

Adults with advanced or metastatic renal medullary carcinoma (RMC), who may or may not have had a kidney removed, and are not currently pregnant or breastfeeding. Participants need to have proper organ function, can be treatment-naïve or previously treated for RMC, and must agree to use effective contraception. Those with controlled brain metastases post-treatment are eligible; however, individuals with severe medical conditions, other recent cancers, HIV/AIDS, uncontrolled brain metastases, active myocarditis or hepatitis B/C infection cannot join.

Inclusion Criteria

Your condition must have gotten worse after your last treatment.

My kidney cancer is advanced or has spread and shows medullary features.

Consent to MD Anderson companion laboratory protocol 2014-0938

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Exclusion Criteria

You have tested positive for hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

I have not received any live vaccines within a week of signing up or during the study.

You have a positive COVID-19 test.

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Treatment Details

Interventions

Nivolumab (Checkpoint Inhibitor)
Relatlimab (Checkpoint Inhibitor)

Trial OverviewThe trial is testing the effectiveness of combining two immunotherapy drugs—nivolumab and relatlimab—in treating RMC that has spread beyond the kidney. The study aims to see if this drug combination can control the disease's progression in patients who meet specific health criteria.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Nivolumab+RelatlimabExperimental Treatment2 Interventions

nivolumab 480 mg IV plus relatlimab 480 mg IV every 4 weeks for up to 2 years

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

🇺🇸 Approved in United States as Opdivo for: