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Checkpoint Inhibitor

Nivolumab + Relatlimab for Melanoma

Phase 2

Waitlist Available

Led By John Kirkwood, MD

Research Sponsored by John Kirkwood

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men or women 18 years of age or older meeting AJCC 8th edition criteria for unresectable stage IIIB, stage IIIC, stage IIID, or stage IV melanoma who have not received treatment with immunotherapy in the metastatic setting

Be older than 18 years old

Must not have

Ocular melanoma

Prior systemic treatment in the metastatic setting, including anti-PD1, anti-PDL1, anti-PDL2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways; or chemotherapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks post initial treatment, up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well a combination of two immunotherapy drugs work against unresectable or metastatic melanoma.

Who is the study for?

Adults with advanced melanoma that hasn't spread to the brain and haven't had immunotherapy before can join. They must not have autoimmune diseases needing treatment (except certain conditions like type 1 diabetes or controlled thyroid issues), no prior cancer treatments in the metastatic stage, and no eye melanoma.

What is being tested?

The trial is testing a combination of two drugs, Relatlimab and Nivolumab, for their effectiveness against advanced melanoma in patients who haven't previously received immunotherapy for their condition.

What are the potential side effects?

Potential side effects may include immune-related reactions affecting various organs, infusion-related symptoms, fatigue, skin rash or itching, digestive discomforts such as diarrhea or nausea, and an increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with advanced melanoma and haven't had immunotherapy for it.

Exclusion Criteria

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

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I have been diagnosed with eye melanoma.

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I have received treatments like immunotherapy or chemotherapy for my cancer after it spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks post initial treatment, up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks post initial treatment, up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks post initial treatment, up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in LAG3 Expression

Change in PD1 expression

Change in Tumor Size

+1 more

Secondary study objectives

Change in CD4+ tumor infiltrating lymphocytes

Change in CD8+ tumor infiltrating lymphocytes

Change in Regulatory T cell (Treg) marker level

+13 more

Other study objectives

Single cell RNA sequencing

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Relatlimab + NivolumabExperimental Treatment1 Intervention

Cycle 1+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV for the first 4 weeks (Cycle 1), then once every 4 weeks afterwards.

Group II: RelatlimabExperimental Treatment1 Intervention

Cycle 1: Relatlimab (BMS-986016) is supplied as a sterile 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV for the first 4 weeks (cycle 1). Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.

Group III: NivolumabExperimental Treatment1 Intervention

Cycle 1: Nivolumab (BMS-936558) is supplied as a sterile 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV for the first 4 weeks. Cycle 2+: Combination therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV once every 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Relatlimab + Nivolumab

2019

Completed Phase 2

~50