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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization up to approximately 3 years

Awards & highlights

RELATIVITY-047 Trial Summary

This trial will compare the effectiveness of two drugs for treating melanoma that has spread or cannot be removed by surgery.

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.Check my eligibility

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.See study design

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.

RELATIVITY-047 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My melanoma is at an advanced stage and cannot be surgically removed.

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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.

RELATIVITY-047 Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization up to approximately 3 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

Progression Free Survival (PFS)

Secondary outcome measures

Overall Response Rate (ORR)

Overall Survival (OS)

Other outcome measures

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 more

Side effects data

From 2023 Phase 1 & 2 trial • 62 Patients • NCT03310619

78%

Anaemia

56%

Neutropenia

44%

Fatigue

44%

Hypomagnesaemia

44%

Cough

44%

Thrombocytopenia

33%

Constipation

33%

Leukopenia

33%

Hypophosphataemia

33%

Cytokine release syndrome

22%

Acute kidney injury

22%

Nausea

22%

Pneumonia

22%

Hypokalaemia

22%

Arthralgia

22%

Dyspnoea exertional

22%

Hypotension

22%

Vision blurred

22%

Pyrexia

22%

Decreased appetite

11%

Dizziness

11%

Tumour lysis syndrome

11%

Neurotoxicity

11%

Mental status changes

11%

Back pain

11%

Haemolytic anaemia

11%

Leukocytosis

11%

Bronchitis

11%

Hyperglycaemia

11%

Pneumothorax

11%

Hyperbilirubinaemia

11%

Staphylococcal sepsis

11%

Hypothyroidism

11%

Proctalgia

11%

Gastrointestinal haemorrhage

11%

Upper respiratory tract infection

11%

Abdominal pain upper

11%

Hypogammaglobulinaemia

11%

Vitreous floaters

11%

Hypotonia

11%

Neuralgia

11%

Depressed mood

11%

Peripheral motor neuropathy

11%

Pleural effusion

11%

Muscle spasms

11%

Sepsis

11%

Tachycardia

11%

Flatulence

11%

Oedema peripheral

11%

Hyperhidrosis

11%

Night sweats

11%

Rash

11%

Acute respiratory failure

11%

Dry mouth

11%

Chronic kidney disease

11%

Hypoxia

11%

Aneurysm

11%

Weight decreased

11%

Colorectal adenoma

11%

Diarrhoea

11%

Chills

11%

Muscular weakness

11%

Tremor

11%

Agitation

11%

Arrhythmia

11%

Lymphopenia

11%

Ventricular tachycardia

11%

Musculoskeletal discomfort

11%

Abdominal pain

11%

Diaphragmalgia

11%

Abdominal distension

11%

Orthostatic hypotension

11%

Colon cancer stage 0

11%

Wheezing

11%

Urinary tract infection

11%

Urine abnormality

11%

Nasal discomfort

11%

Vascular access site bruising

11%

Hypoaesthesia

11%

Epicondylitis

11%

Memory impairment

11%

Restless legs syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Cohort 1B JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm F: Cohort 1A Cohort 1A and 1D JCAR017 Plus CC-99282 (Post-JCAR017 Infusion)

Arm B: Cohort 1A JCAR017 Plus CC-122 (Post-JCAR017 Infusion)

Arm A: Cohort 1A JCAR017 Plus Durvalumab (Post-JCAR017 Infusion)

Arm C: Cohort 1A JCAR017 Plus CC-220 (Iberdomide) (Post-JCAR017 Infusion)

Arm D: Cohort 1A JCAR017 Plus Ibrutinib (Pre- and 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)

RELATIVITY-047 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

2014

Completed Phase 3

~4750

Relatlimab

2018

Completed Phase 2

~1120

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,647 Previous Clinical Trials

4,130,575 Total Patients Enrolled

177 Trials studying Melanoma

56,771 Patients Enrolled for Melanoma

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03470922 — Phase 2 & 3

Melanoma Research Study Groups: Arm A: Relatlimab + Nivolumab, Arm B: Nivolumab

Melanoma Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT03470922 — Phase 2 & 3

Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03470922 — Phase 2 & 3

Frequently Asked Questions

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

Are people being recruited for this study right now?

"Currently, this clinical trial is not looking for more participants. However, this may change in the future as the study was last updated on September 8th, 2022. Additionally, there are 1530 other trials that are presently accepting patients."

Answered by AI

What are the origins of this clinical trial?

"Relatlimab has been under investigation for a decade. In 2010, Medarex ran the first clinical trial with 127 participants. Based on the success of this study, Relatlimab received Phase 1 drug approval. At present, there are 749 active trials in 2348 cities and 50 countries."

Answered by AI

How many individuals are enrolled in this clinical trial?

"Recruitment for this trial has ceased. The listing was first published on April 11th, 2018 and underwent its final edit on September 8th, 2022. There are 781 and 749 studies currently recruiting patients with melanoma and Relatlimab respectively."

Answered by AI

What is Relatlimab's primary therapeutic purpose?

"Relatlimab is an immunotherapy medication that can be used to treat a patient suffering from malignant neoplasms, unresectable melanoma, or squamous cell carcinoma."

Answered by AI

Are there any other drugs in development that are similar to Relatlimab?

"Relatlimab was first studied a decade ago, at H. Lee Moffitt Cancer Center and Research Institute. So far, there is a body of 249 completed studies to draw data from. Additionally, there are 749 active clinical trials involving relatlimab with many of these being performed in Montreal, Quebec."

Answered by AI

In how many different medical settings is this research project being conducted today?

"Patients are currently being accepted at 50 different institutions across North America, including Local Institution - 0075 in Montreal, Quebec, Local Institution - 0120 in Baltimore, Maryland and Local Institution - 0018 in Charlotte, North carolina."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Relatlimab and Nivolumab Versus Nivolumab in Untreated Advanced Melanoma

Tawbi, Hussein A., Dirk Schadendorf, Evan J. Lipson, Paolo A. Ascierto, Luis Matamala, Erika Castillo Gutiérrez, Piotr Rutkowski, et al.. 2022. “Relatlimab and Nivolumab Versus Nivolumab in Untreated Advanced Melanoma”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa2109970.

clinicaltrials.govStudy

A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma

2018. "A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03470922.

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