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Checkpoint Inhibitor

Nivolumab + Relatlimab for Melanoma Brain Metastases

Phase 2

Recruiting

Led By Hussein Tawbi, MD, PHD

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 old

Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) OR at least 4 unstained slides, with an associated pathology report, for testing of tumor PD-L1 expression

Must not have

Non-healing wound, ulcer, or bone fracture

Subject has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years. Note: The time requirement does not apply to participants who underwent successful treatment of superficial bladder cancer, in situ cervical cancer, or other in-situ cancers. Subjects with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial examines if a drug combo can help control brain mets from melanoma and assess safety of the drugs.

Who is the study for?

This trial is for adults with melanoma that has spread to the brain. Participants must have a measurable brain tumor, be able to follow the study plan, and not have had certain previous treatments like checkpoint inhibitors in the metastatic setting or whole-brain radiation. They should not need steroids, be pregnant or breastfeeding, and must use birth control if applicable.

What is being tested?

The trial tests combining Nivolumab with Relatlimab against active melanoma brain metastases. It aims to see if this drug combination can control cancer growth in the brain and will also monitor safety and side effects of these drugs when used together.

What are the potential side effects?

While specific side effects are not listed here, similar immunotherapy combinations often include risks such as inflammation in various organs, infusion reactions (like fever or chills), fatigue, skin issues, potential hormonal imbalances due to immune system effects on glands like thyroid.

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 provide tumor samples in blocks or slides for PD-L1 testing.

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I have melanoma with measurable brain metastases.

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My tumor is between 0.5cm and 3cm in size, confirmed by MRI.

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I don't have brain-related symptoms from cancer and haven't taken steroids in the last 5 days.

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I have a brain lesion that has not been treated with targeted radiation.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

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

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I have a wound, ulcer, or bone fracture that hasn’t healed.

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I had cancer before, but it's been treated and I've been cancer-free for over 2 years.

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I am on low-dose steroids or other immune-suppressing drugs, but not for an active autoimmune disease.

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I have had targeted radiation for more than 5 brain lesions but no whole brain radiation.

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I am not pregnant or breastfeeding.

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I have a history of cancer spreading to the lining of my brain and spinal cord.

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I had precise radiotherapy, not including my brain lesion, within the last week.

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I haven't had major surgery or significant injury in the last 14 days, and I don't expect to need major surgery during the study.

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I have or had lung inflammation treated with steroids.

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: Relatlimab+NivolumabExperimental Treatment3 Interventions

Participants will receive nivolumab in combination with relatlimab by vein over about 30 minutes on Day 1 of each 28-day study cycle. You may receive up to 25 doses of the study drugs.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Relatlimab

2019

Completed Phase 2

~1150

Nivolumab

2015

Completed Phase 3

~4010