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Checkpoint Inhibitor
Relatlimab + Nivolumab for Advanced Melanoma (RELATIVITY-047 Trial)
Phase 2 & 3
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have histologically confirmed Stage III (unresectable) or Stage IV melanoma, per the AJCC staging system
Participants must not have had prior systemic anticancer therapy for unresectable or metastatic melanoma
Must not have
Participants must not have active brain metastases or leptomeningeal metastases
Participants must not have uveal melanoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization up to approximately 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if using two medications together (relatlimab and nivolumab) is better than using just one (nivolumab) for treating a type of skin cancer that can't be removed by surgery or has spread. The drugs help the immune system to better recognize and attack cancer cells.
Who is the study for?
This trial is for individuals with advanced melanoma that can't be removed by surgery or has spread, and who haven't had previous systemic cancer treatments. They must have a confirmed diagnosis of Stage III (unresectable) or Stage IV melanoma and provide tumor tissue for analysis. People with active brain metastases, uveal melanoma, or autoimmune diseases cannot participate.
What is being tested?
The study is testing the effectiveness of combining two drugs: Relatlimab and Nivolumab versus using Nivolumab alone in treating advanced melanoma. The goal is to see if the combination works better than just one drug on its own.
What are the potential side effects?
Potential side effects from Relatlimab and Nivolumab may include immune-related reactions such as inflammation in various organs, skin rash, hormone gland problems, infusion-related reactions, fatigue, and flu-like symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My melanoma is at an advanced stage and cannot be surgically removed.
Select...
I have not received systemic anticancer therapy for my advanced melanoma.
Select...
I can provide a tissue sample from my cancer that cannot be surgically removed.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have cancer that has spread to my brain or its coverings.
Select...
I do not have eye melanoma.
Select...
I do not have any known autoimmune diseases.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization up to approximately 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization up to approximately 3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Overall Response Rate (ORR)
Overall Survival (OS)
Other study objectives
The Number of Participant Deaths in the Study
The Number of Participants Experiencing Adverse Events (AEs)
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
+3 moreSide effects data
From 2023 Phase 1 & 2 trial • 62 Patients • NCT0331061943%
Neutrophil count decreased
29%
Anaemia
29%
White blood cell count decreased
14%
Back pain
14%
Blood uric acid increased
14%
Erythema
14%
COVID-19
14%
Headache
14%
Neurotoxicity
14%
Neutropenia
14%
Palpitations
14%
Dry eye
14%
Diarrhoea
14%
Dyspepsia
14%
Chills
14%
Oedema peripheral
14%
Cytokine release syndrome
14%
Pneumonia
14%
Aspartate aminotransferase increased
14%
International normalised ratio increased
14%
Lymphocyte count decreased
14%
Platelet count decreased
14%
Dehydration
14%
Hypokalaemia
14%
Hypomagnesaemia
14%
Bone pain
14%
Myalgia
14%
Pain in jaw
14%
Dizziness
14%
Nystagmus
14%
Confusional state
14%
Cough
14%
Dyspnoea
14%
Tachypnoea
14%
Alopecia
14%
Rash maculo-papular
14%
Embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and Post-JCAR017 Infusion)
Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)
Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)
Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)
Arm E: Cohort 1C JCAR017 Plus Relatlimab and/or Nivolumab (Post-JCAR017 Infusion)
Arm F: Cohort 1D Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)
Awards & 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: Arm B: NivolumabExperimental Treatment1 Intervention
Monotherapy
Group II: Arm A: Relatlimab + NivolumabExperimental Treatment2 Interventions
Combination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010
Relatlimab
2019
Completed Phase 2
~1150
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Immune checkpoint inhibitors, such as Relatlimab and Nivolumab, are pivotal in treating melanoma by targeting specific pathways that regulate the immune system. Nivolumab blocks the PD-1 pathway, which normally acts as a brake on T-cells, preventing them from attacking cancer cells.
By inhibiting PD-1, Nivolumab enhances the immune response against melanoma. Relatlimab targets the LAG-3 pathway, another checkpoint that dampens T-cell activity.
Blocking LAG-3 further boosts the immune system's ability to fight melanoma. These mechanisms are crucial for melanoma patients as they can lead to more effective and sustained anti-tumor responses, offering hope for better outcomes in advanced or unresectable cases.
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,691 Previous Clinical Trials
4,096,874 Total Patients Enrolled
179 Trials studying Melanoma
57,001 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma is at an advanced stage and cannot be surgically removed.I have not received systemic anticancer therapy for my advanced melanoma.I can provide a tissue sample from my cancer that cannot be surgically removed.I do not have cancer that has spread to my brain or its coverings.I do not have eye melanoma.I do not have any known autoimmune diseases.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A: Relatlimab + Nivolumab
- Group 2: Arm B: 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.