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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in LAG3 Expression

Change in PD1 expression

Change in Tumor Size

+1 more

Secondary outcome measures

Change in CD4+ tumor infiltrating lymphocytes

Change in CD8+ tumor infiltrating lymphocytes

Change in Regulatory T cell (Treg) marker level

+13 more

Other outcome measures

Single cell RNA sequencing

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

2014

Completed Phase 3

~4750

Relatlimab

2018

Completed Phase 2

~1110

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,472 Total Patients Enrolled

177 Trials studying Melanoma

57,501 Patients Enrolled for Melanoma

John KirkwoodLead Sponsor

4 Previous Clinical Trials

82 Total Patients Enrolled

4 Trials studying Melanoma

82 Patients Enrolled for Melanoma

John Kirkwood, MDPrincipal Investigator - University of Pittsburgh

UPMC Shadyside

Yale University School Of Medicine (Medical School)

Yale New Haven Hospital (Residency)

4 Previous Clinical Trials

71 Total Patients Enrolled

4 Trials studying Melanoma

71 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots left in this research endeavor?

"As confirmed on clinicaltrials.gov, this medical investigation is actively enrolling participants. It was initially advertised in March 2019 and its latest revisions were made in April 2022."

Answered by AI

Is this experiment a pioneering venture in its field?

"Relatlimab + Nivolumab has seen a surge of popularity in clinical trials since Ono Pharmaceutical Co. Ltd conducted its Phase 1 & 2 study involving 659 participants back in 2012. Since then, 720 studies have been carried out across 2355 cities and 49 countries - 252 of which are still active today."

Answered by AI

What medical conditions are commonly treated with Relatlimab + Nivolumab?

"Relatlimab + Nivolumab is the drug of choice when treating malignant neoplasms, but it can also be utilized to address unresectable melanoma, squamous cell carcinoma and metastatic esophageal adenocarcinoma."

Answered by AI

What does this trial intend to achieve?

"The primary endpoint of this Bristol-Myers Squibb sponsored study, which will assess outcomes over a period lasting up to 4 years from the initial treatment date, is Change in LAG3 Expression. Secondary endpoints include Duration of Response (time until first documented progression), Change in T cell count, and Change in CD8+ tumor infiltrating lymphocytes (number/percentage)."

Answered by AI

Have there been any other investigations into the effects of Relatlimab and Nivolumab in combination?

"Presently, there are 720 studies in existence that involve a combination of Relatlimab and Nivolumab. Out of these trials, 82 have advanced to the third phase. While most take place within Basel-BE, 40321 sites across the globe are running research on this medication."

Answered by AI

What adverse effects have been reported concerning the combination of Relatlimab and Nivolumab?

"Our assessment of Relatlimab + Nivolumab's safety is a 2, as there is some evidence supporting its security but no data backing up its efficacy."

Answered by AI

What is the current capacity for enrollees in this research project?

"Affirmative. According to information housed on clinicaltrials.gov, this research endeavor is presently taking applications and was initially posted on March 29th 2019 with the most recent update occurring April 19th 2022. 42 participants are being sought at a single site of study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting

John Kirkwood 2019. "Nivolumab, BMS-936558 in Combination With Relatlimab, BMS-986016 in Patients With Metastatic Melanoma Naïve to Prior Immunotherapy in the Metastatic Setting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03743766.

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