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MelanomaPhase 2/3RELATIVITY-047NCT03470922

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

A Phase 2/3 study testing Relatlimab and Nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 127 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Melanoma
What is being tested?
Relatlimab and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
714 participants
Where
127 sitesin 25 countries
Study dates
11 Apr 2018to 15 Dec 2030
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
  • Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses

Who cannot join

  • Participants must not have active brain metastases or leptomeningeal metastases
  • Participants must not have uveal melanoma
  • Participants must not have an active, known, or suspected autoimmune disease
  • Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

127 sites in 25 countries.

127 sites in 25 countries

United States22 sites

  • Local Institution - 0019

    Allentown, Pennsylvania, 18103

  • Local Institution - 0015

    Ann Arbor, Michigan, 48109

  • Local Institution - 0038

    Atlanta, Georgia, 30342

  • Local Institution - 0077

    Baltimore, Maryland, 21237

  • Local Institution - 0120

    Baltimore, Maryland, 21287

  • Local Institution - 0014

    Boston, Massachusetts, 02215

  • Local Institution - 0134

    Boston, Massachusetts, 02215

  • Local Institution - 0018

    Charlotte, North Carolina, 28204

  • Local Institution - 0016

    Chicago, Illinois, 60611

  • Local Institution - 0076

    Dallas, Texas, 75246

  • Local Institution - 0114

    Fort Wayne, Indiana, 46804

  • Local Institution - 0008

    Houston, Texas, 77030

  • Local Institution - 0013

    Jacksonville, Florida, 32224

  • Local Institution - 0020

    Los Angeles, California, 90095

  • Local Institution - 0009

    Minneapolis, Minnesota, 55407

  • Local Institution - 0117

    Orlando, Florida, 32806

  • Local Institution - 0011

    Rochester, Minnesota, 55905

  • Coastal Integrative Cancer Care

    San Luis Obispo, California, 93401

  • Local Institution - 0116

    Santa Barbara, California, 93105

  • Local Institution - 0007

    Tampa, Florida, 33612

  • Local Institution - 0010

    Tucson, Arizona, 85724-5024

  • Local Institution - 0012

    Washington D.C., District of Columbia, 20007

Other trials in United States

Germany13 sites

  • Local Institution - 0032

    Buxtehude, 21614

  • Local Institution - 0029

    Cologne, 50937

  • Local Institution - 0030

    Erfurt, 99089

  • Local Institution - 0027

    Essen, 45147

  • Local Institution - 0033

    Hanover, 30625

  • Local Institution - 0132

    Heidelberg, Baden-Wurttemberg, 69120

  • Local Institution - 0074

    Homburg / Saar, 66421

  • Local Institution - 0028

    Lübeck, 23538

  • Local Institution - 0072

    Mannheim, 68167

  • Local Institution - 0034

    München, 81675

  • Local Institution - 0071

    Quedlinburg, Saxony-Anhalt, 06484

  • Local Institution - 0131

    Tübingen, Baden-Wurttemberg, 72076

  • Local Institution - 0031

    Würzburg, 97080

Other trials in Germany

Brazil8 sites

  • Local Institution - 0058

    Belo Horizonte, Minas Gerais, 30130-090

  • Local Institution - 0057

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution - 0061

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Local Institution - 0059

    Rio de Janiro, 20220-410

  • Local Institution - 0073

    Santa Cruz do Sul, Rio Grande do Sul, 96810-110

  • Local Institution - 0063

    São Paulo, São Paulo, 05651-901

  • Local Institution - 0060

    São Paulo, 01246-000

  • Local Institution - 0062

    São Paulo, 01509-010

Other trials in Brazil

France8 sites

  • Local Institution - 0079

    Amiens, Somme, 80000

  • Local Institution - 0080

    Bordeaux, 33075

  • Local Institution - 0085

    Lille, 59000

  • Local Institution - 0081

    Marseille, 13011

  • Local Institution - 0083

    Paris, 75010

  • Local Institution - 0078

    Pierre-Bénite, 69310

  • Local Institution - 0082

    Poitiers, 86000

  • Local Institution - 0084

    Rennes, Ille-et-Vilaine, 35042

Other trials in France

Australia6 sites

  • Local Institution - 0133

    Bedford Park, South Australia, 5042

  • Local Institution - 0041

    Greenslopes, Queensland, 4120

  • Local Institution - 0044

    Murdoch, Western Australia, 6150

  • Local Institution - 0042

    North Sydney, New South Wales, 2060

  • Local Institution - 0045

    Southport, Queensland, 4215

  • Local Institution - 0043

    Waratah, New South Wales, 2298

Other trials in Australia

Italy6 sites

  • Local Institution - 0109

    Bergamo, 24127

  • Local Institution - 0108

    Milan, 20133

  • Local Institution - 0106

    Naples, 80131

  • Local Institution - 0110

    Padova, 35128

  • Local Institution - 0107

    Siena, 53100

  • Local Institution - 0111

    Turin, Piedmont, 10126

Other trials in Italy

Spain6 sites

  • Local Institution - 0023

    A Coruña, 15006

  • Local Institution - 0024

    Barcelona, 08035

  • Local Institution - 0025

    Barcelona, 08036

  • Local Institution - 0026

    Madrid, 28034

  • Local Institution - 0021

    San Sabastian Gipuzkoa, 20014

  • Local Institution - 0022

    Seville, 41009

Other trials in Spain

Argentina5 sites

  • Local Institution - 0135

    Buenos Aires, Distrito Federal, 1121

  • Local Institution - 0004

    Buenos Aires, 1199

  • Local Institution - 0003

    Buenos Aires, 1426

  • Local Institution - 0005

    Buenos Aires, 4102-4200

  • Local Institution - 0002

    Capital Federal, Distrito Federal, C1280AEB

Other trials in Argentina

Canada5 sites

  • Local Institution - 0124

    Halifax, Nova Scotia, B3H 2Y9

  • Local Institution - 0123

    Montreal, Quebec, H3T 1E2

  • Local Institution - 0075

    Montreal, Quebec, H4A 3J1

  • Local Institution - 0068

    Ottawa, Ontario, K1H 8L6

  • Local Institution - 0128

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Mexico5 sites

  • Local Institution - 0093

    Cancún, Quintana Roo, 77500

  • Local Institution - 0092

    Mérida, Yucatán, 97130

  • Local Institution - 0091

    Monterrey, Nuevo León, 64060

  • Local Institution - 0129

    Veracruz, 91900

  • Local Institution - 0094

    Zapopan, Jalisco, 45070

Other trials in Mexico

United Kingdom5 sites

  • Local Institution - 0052

    Bristol, Avon, BS2 8ED

  • Local Institution - 0054

    Glasgow, Dumfries & Galloway, G12 0YN

  • Local Institution - 0126

    Inverness, Inverness-shire, IV2 3UJ

  • Local Institution - 0051

    London, Greater London, SE1 9RT

  • Local Institution - 0056

    Swansea, Glamorgan, SA2 8QA

Other trials in United Kingdom

Finland4 sites

  • Local Institution - 0100

    Helsinki, Uusimaa, 00290

  • Local Institution - 0102

    Oulu, 90220

  • Local Institution - 0119

    Tampere, 33521

  • Local Institution - 0101

    Turku, 20520

Other trials in Finland

Romania4 sites

  • Local Institution - 0066

    Bucharest,  022328

  • Local Institution - 0070

    Cluj-Napoca, Cluj, 400015

  • Local Institution - 0067

    Craiova, 200542

  • Local Institution - 0069

    Iași, 700483

Other trials in Romania

Sweden4 sites

  • Local Institution - 0098

    Gothenburg, 413 45

  • Local Institution - 0099

    Lund, 221 85

  • Local Institution - 0118

    Solna, 171 64

  • Local Institution - 0122

    Uppsala, 751 85

Other trials in Sweden

Austria3 sites

  • Local Institution - 0036

    Graz, Styria, 8036

  • Local Institution - 0037

    Salzburg, 5020

  • Local Institution - 0035

    Vienna, 1090

Other trials in Austria

Belgium3 sites

  • Local Institution - 0047

    Brussels, 1090

  • Local Institution - 0049

    Brussels, 1200

  • Local Institution - 0048

    Ghent, 9000

Other trials in Belgium

Denmark3 sites

  • Local Institution - 0105

    Aarhus N, Central Jutland, 8200

  • Local Institution - 0103

    Herlev, 2730

  • Local Institution - 0104

    Odense, 5000

Other trials in Denmark

Israel3 sites

  • Local Institution - 0086

    Haifa, 3109601

  • Local Institution - 0088

    Jerusalem, 91120

  • Local Institution - 0087

    Ramat Gan, 52621

Other trials in Israel

New Zealand3 sites

  • Local Institution - 0090

    Dunedin, 9012

  • Local Institution - 0125

    Hamilton, 3240

  • Local Institution - 0089

    Tauranga, 3112

Other trials in New Zealand

Russia3 sites

  • Local Institution - 0113

    Krasnodar, 350040

  • Local Institution - 0127

    Krasnoyarsk, 660133

  • Local Institution - 0112

    Moscow, 115478

Other trials in Russia

Colombia2 sites

  • Local Institution - 0095

    Bogotá, 110321

  • Local Institution - 0096

    Medellín, Antioquia, 050030

Other trials in Colombia

Greece2 sites

  • Local Institution - 0064

    Athens, 11526

  • Local Institution - 0065

    Thessaloniki, 54622

Other trials in Greece

Poland2 sites

  • Local Institution - 0040

    Poznan, 60-780

  • Local Institution - 0039

    Warsaw, 02-781

Other trials in Poland

Chile1 site

  • Local Institution - 0001

    Santiago, Santiago Metropolitan

Other trials in Chile

Norway1 site

  • Local Institution - 0121

    Oslo, 0310

Other trials in Norway

About this study

Official title: A Randomized, Double-Blind Phase 2/3 Study of Relatlimab Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Metastatic or Unresectable Melanoma

The purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab monotherapy in treating unresectable melanoma or melanoma that has spread.

Conditions
Melanoma
Being tested
Relatlimab, Nivolumab
Keywords
Cancer, Advanced Cancer
Medical subject headings
Melanoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RelatlimabBiological

    Specified dose on specified day

  • NivolumabBiological

    Specified dose on specified days

Study groups in NCT03470922
Study groupRoleWhat they receive
Arm A: Relatlimab + NivolumabExperimentalCombination
Receives: Biological: Relatlimab; Biological: Nivolumab
Arm B: NivolumabExperimentalMonotherapy
Receives: Biological: Nivolumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Progression Free Survival (PFS) is defined as the time between the date of randomization and the date of first documented tumor progression, assessed by a blinded independent central review (BICR) (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Subjects who die without a reported progression will be considered to have progressed on the date of their death.

    Measured: From randomization to date of first documented tumor progression or death (up to approximately 33 months)

Secondary outcomes (2)

  1. Overall Survival (OS)

    Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause. For subjects that are alive, their survival time will be censored at the date of last contact ("last known alive date").

    Measured: From randomization to the date of death (up to approximately 3 years)

  2. Overall Response Rate (ORR)

    Objective response rate (ORR) is defined as the number of randomized subjects who achieve a best response of complete response (CR) or partial response (PR) based on BICR assessments (using RECIST v1.1 criteria).

    Measured: From randomization up to approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2018
  2. Study start11 Apr 2018
  3. Primary completion25 Jan 2021
  4. Study completion15 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
714 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03470922
Sponsor's protocol ID
CA224-047
Other IDs
2024-510913-13
Acronym
RELATIVITY-047
Status last verified
Aug 2025
First submitted
14 Mar 2018
Last updated
9 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Long GV, Dolfi S, Hodi FS, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Fecher LA, Lao CD, De Menezes JJ, Dalle S, Arance A, Gaudy-Marqueste C, Murillo E, Maio M, Rohde M, Garnett-Benson C, Jiang R, Chen B, Yu JX, Hollmann T, Zuchtriegel G, Tawbi H. Relatlimab plus nivolumab versus nivolumab for advanced melanoma: 5-year survival and biomarker analyses of the phase 3 RELATIVITY-047 trial. Nat Med. 2026 Oct 24. doi: 10.1038/s41591-026-04756-1. Online ahead of print.

    PubMed 42926136

  • Bautista J, Echeverria CE, Maldonado-Noboa I, Adatty-Molina J, Suarez Urresta S, Coral-Riofrio EC, Araujo-Abad S, Kyriakidis NC, Lopez-Cortes A. Next-Generation Immune Checkpoints and Tumor Microenvironment Modulation in Cancer Immunotherapy. J Immunol Res. 2026;2026(1):e7864229. doi: 10.1155/jimr/7864229.

    PubMed 41811823

  • Regan MM, Ascierto PA MD, Lipson EJ, Palaia J, Moshyk A, Selvan A, Lao CD, Atkins MB MD, McDermott DF, Potluri R, Ranjan S, Bilthare S, Long GV, Stephen Hodi F, Tawbi H, Schadendorf D. Analysis of treatment-free survival of patients with advanced melanoma receiving nivolumab as monotherapy or in combination with relatlimab in RELATIVITY-047. J Immunother Cancer. 2025 Sep 12;13(9):e012747. doi: 10.1136/jitc-2025-012747.

    PubMed 40940136

  • Lipson EJ, Stephen Hodi F, Tawbi H, Schadendorf D, Ascierto PA, Matamala L, Gutierrez EC, Rutkowski P, Gogas HJ, Lao CD, Menezes JJ, Dalle S, Arance A, Gaudy-Marqueste C, Chen B, Jackson W, Mukherjee S, Dolfi S, Long GV. Nivolumab plus relatlimab in advanced melanoma: RELATIVITY-047 4-year update. Eur J Cancer. 2025 Jul 25;225:115547. doi: 10.1016/j.ejca.2025.115547. Epub 2025 Jun 3.

    PubMed 40513285

  • Tawbi HA, Hodi FS, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas H, Lao CD, Janoski De Menezes J, Dalle S, Arance AM, Grob JJ, Ratto B, Rodriguez S, Mazzei A, Dolfi S, Long GV. Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047. J Clin Oncol. 2025 May;43(13):1546-1552. doi: 10.1200/JCO.24.01124. Epub 2024 Dec 13.

    PubMed 39671533

  • Long GV, Stephen Hodi F, Lipson EJ, Schadendorf D, Ascierto PA, Matamala L, Salman P, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, Janoski De Menezes J, Dalle S, Arance A, Grob JJ, Keidel S, Shaikh A, Sobiesk AM, Dolfi S, Tawbi HA. Overall Survival and Response with Nivolumab and Relatlimab in Advanced Melanoma. NEJM Evid. 2023 Apr;2(4):EVIDoa2200239. doi: 10.1056/EVIDoa2200239. Epub 2023 Mar 22.

    PubMed 38320023

  • Schadendorf D, Tawbi H, Lipson EJ, Stephen Hodi F, Rutkowski P, Gogas H, Lao CD, Grob JJ, Moshyk A, Lord-Bessen J, Hamilton M, Guo S, Shi L, Keidel S, Long GV. Health-related quality of life with nivolumab plus relatlimab versus nivolumab monotherapy in patients with previously untreated unresectable or metastatic melanoma: RELATIVITY-047 trial. Eur J Cancer. 2023 Jul;187:164-173. doi: 10.1016/j.ejca.2023.03.014. Epub 2023 Mar 22.

    PubMed 37167764

  • Raschi E, Comito F, Massari F, Gelsomino F. Relatlimab and nivolumab in untreated advanced melanoma: insight into RELATIVITY. Immunotherapy. 2023 Feb;15(2):85-91. doi: 10.2217/imt-2022-0172. Epub 2023 Jan 11.

    PubMed 36628573

  • Tawbi HA, Schadendorf D, Lipson EJ, Ascierto PA, Matamala L, Castillo Gutierrez E, Rutkowski P, Gogas HJ, Lao CD, De Menezes JJ, Dalle S, Arance A, Grob JJ, Srivastava S, Abaskharoun M, Hamilton M, Keidel S, Simonsen KL, Sobiesk AM, Li B, Hodi FS, Long GV; RELATIVITY-047 Investigators. Relatlimab and Nivolumab versus Nivolumab in Untreated Advanced Melanoma. N Engl J Med. 2022 Jan 6;386(1):24-34. doi: 10.1056/NEJMoa2109970.

    PubMed 34986285

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Relatlimab and Nivolumab in people with Melanoma, run by Bristol-Myers Squibb at 127 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 127 sites in United States, Germany, Brazil, France, Australia and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From randomization to date of first documented tumor progression or death (up to approximately 33 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03470922, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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