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Checkpoint Inhibitor
Relatlimab + Nivolumab + Ipilimumab for Melanoma
Phase 2
Waitlist Available
Led By Allison B Warner, MD, PhD
Research Sponsored by Stanford University
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) performance status 0-1 for Cohort A, ECOG performance status 0-2 for Cohort B
Must not have
Women who are breast-feeding or pregnant
History of clinically significant cardiac disease or congestive heart failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 month
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a combination of three drugs in patients with melanoma that has spread to the brain, both in patients with and without symptoms.
Who is the study for?
This trial is for individuals with melanoma that has spread to the brain, whether or not they have symptoms. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on factors like other medical conditions or treatments.
What is being tested?
The study is testing a combination of three drugs: Relatlimab (rela), Nivolumab (nivo), and Ipilimumab (ipi) in patients with melanoma brain metastases. It's a phase II trial, which means it focuses on the effectiveness of this drug combo and further evaluates its safety.
What are the potential side effects?
While specific side effects aren't listed here, drugs like Relatlimab, Nivolumab, and Ipilimumab can cause immune-related reactions affecting various organs, fatigue, skin issues, digestive problems, hormonal changes and flu-like symptoms.
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 am fully active or have some restrictions but can still care for myself.
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I haven't received specific immune therapies for advanced melanoma.
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I have received radiation for cancer outside of my brain.
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My melanoma has spread to my brain and can be measured on a scan.
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My organs are functioning well.
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I have recovered from previous cancer treatment side effects to a mild level.
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I understand the study's requirements and can give my written consent.
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I have brain symptoms from cancer spread.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant or breastfeeding.
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I have a history of serious heart disease or heart failure.
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I have not taken more dexamethasone than allowed.
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I have had whole brain radiation therapy before.
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I had a severe side effect from previous immune therapy.
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I have had cancer spread to the lining of my brain and spinal cord.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 month
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Intracranial clinical benefit rate
Secondary study objectives
Duration of response
Evaluation of Safety and Adverse Events Using CTCAE v5.0
Extracranial clinical benefit rate
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort B: SymptomaticExperimental Treatment2 Interventions
Group II: Cohort A: AsymptomaticExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2015
Completed Phase 3
~3420
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,491 Previous Clinical Trials
17,519,009 Total Patients Enrolled
8 Trials studying Melanoma
810 Patients Enrolled for Melanoma
Allison B Warner, MD, PhDPrincipal InvestigatorStanford University