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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
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 belowSelect...
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:Select...
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.
Select...
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
Treatment Details
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
2018
Completed Phase 2
~1110
Nivolumab
2014
Completed Phase 3
~5220
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,671 Total Patients Enrolled
Hussein Tawbi, MD, PHDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
51 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had surgery and radiation for up to 5 brain metastases and fully recovered without any lasting brain issues.I am not pregnant, not breastfeeding, and will use birth control during and after the study.My side effects from previous cancer treatments are mild or gone, except for stable hormone issues.I had cancer before, but it's been treated and I've been cancer-free for over 2 years.I had brain surgery or radiation at least 1 week before this study starts.My cancer has spread to the bones, making it hard to test for PD-L1, but I might still join the trial.I have a wound, ulcer, or bone fracture that hasn’t healed.I am 18 years old or older.I can provide tumor samples in blocks or slides for PD-L1 testing.You have been diagnosed with HIV, the virus that causes AIDS.I have melanoma with measurable brain metastases.My organs are functioning well.I haven't taken any experimental drugs recently.I can have a biopsy if I don't have tissue samples, but not by fine needle aspiration.If your Troponin T (TnT) or Troponin I (TnI) levels are higher than 2 times the normal limit, you may not be able to participate. If your levels are between 1 to 2 times the normal limit, you may be allowed to participate after consulting with a heart specialist. If the repeat levels are within 24 hours and lower than 1 times the normal limit, you may still be able to participate with a heart specialist's recommendation. If the repeat levels are not available within 24 hours, you should have a repeat test as soon as possible. If the repeat levels beyond 24 hours are lower than 2 times the normal limit, you may still be able to participate with a heart specialist's recommendation.You have a current or past positive test for hepatitis B or C. If you don't know your history, you will be tested to check for eligibility.I am taking steroids only as a replacement therapy.I have skin cancer but it doesn't need to be removed before treatment.I am on low-dose steroids or other immune-suppressing drugs, but not for an active autoimmune disease.My tumor is between 0.5cm and 3cm in size, confirmed by MRI.I don't have brain-related symptoms from cancer and haven't taken steroids in the last 5 days.I do not have serious heart problems or recent heart attacks.I have had targeted radiation for more than 5 brain lesions but no whole brain radiation.I do not have any severe infections or health conditions that would stop me from participating in the study.I have a brain lesion that has not been treated with targeted radiation.You are expected to live for at least 12 weeks.I am not pregnant or breastfeeding.I have a history of cancer spreading to the lining of my brain and spinal cord.I had precise radiotherapy, not including my brain lesion, within the last week.You have brain lesions larger than 3 cm.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.I've had checkpoint inhibitor therapy for cancer that has spread, with at least 6 months since my last dose.I have an autoimmune disease but it's either mild or well-managed.I haven't taken corticosteroids for 10 days, except as a replacement therapy.I have had radiation therapy on parts of my body excluding the brain.I have or had lung inflammation treated with steroids.I am fully active and can carry on all my pre-disease activities without restriction.
Research Study Groups:
This trial has the following groups:- Group 1: Relatlimab+Nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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