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

Melanoma Clinical Trial

— RELATIVITY-047  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03470922
• Other study ID #: CA224-047
• Secondary ID: 2017-003583-12
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: April 11, 2018
• Est. completion date: December 16, 2025

Study information

• Verified date: September 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 714
• Est. completion date: December 16, 2025
• Est. primary completion date: January 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Relatlimab
Specified dose on specified day
• Nivolumab
Specified dose on specified days

Locations

Country	Name	City	State
Argentina	Local Institution - 0004	Buenos Aires
Argentina	Local Institution - 0005	Buenos Aires
Argentina	Local Institution - 0135	Buenos Aires	Distrito Federal
Argentina	Local Institution - 0002	Capital Federal	Distrito Federal
Argentina	Local Institution - 0003	Ciudad Autónoma De Buenos Aires
Australia	Local Institution - 0133	Bedford Park	South Australia
Australia	Local Institution - 0041	Greenslopes	Queensland
Australia	Local Institution - 0044	Murdoch	Western Australia
Australia	Local Institution - 0042	North Sydney	New South Wales
Australia	Local Institution - 0045	Southport	Queensland
Australia	Local Institution - 0043	Waratah	New South Wales
Austria	Local Institution - 0036	Graz
Austria	Local Institution - 0037	Salzburg
Austria	Local Institution - 0035	Wien
Belgium	Local Institution - 0047	Brussels
Belgium	Local Institution - 0049	Bruxelles
Belgium	Local Institution - 0048	Gent
Brazil	Local Institution - 0058	Belo Horizonte	Minas Gerais
Brazil	Local Institution - 0057	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0061	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution - 0059	Rio De Janiro
Brazil	Local Institution - 0073	Santa Cruz do Sul	RIO Grande DO SUL
Brazil	Local Institution - 0060	Sao Paulo
Brazil	Local Institution - 0062	Sao Paulo
Brazil	Local Institution - 0063	São Paulo	SAO Paulo
Canada	Local Institution - 0124	Halifax	Nova Scotia
Canada	Local Institution - 0075	Montreal	Quebec
Canada	Local Institution - 0123	Montreal	Quebec
Canada	Local Institution - 0068	Ottawa	Ontario
Canada	Local Institution - 0128	Toronto	Ontario
Chile	Local Institution - 0001	Santiago	Metropolitana
Colombia	Local Institution - 0095	Bogota
Colombia	Local Institution - 0096	Medellín	Antioquia
Denmark	Local Institution - 0105	Aarhus N
Denmark	Local Institution - 0103	Herlev
Denmark	Local Institution - 0104	Odense
Finland	Local Institution - 0100	Helsinki	Uusimaa
Finland	Local Institution - 0102	Oulu
Finland	Local Institution - 0119	Tampere
Finland	Local Institution - 0101	Turku
France	Local Institution - 0079	Amiens	Somme
France	Local Institution - 0080	Bordeaux Cedex
France	Local Institution - 0085	Lille
France	Local Institution - 0081	Marseille
France	Local Institution - 0083	Paris
France	Local Institution - 0078	Pierre-Benite
France	Local Institution - 0082	Poitiers
France	Local Institution - 0084	Rennes	Ille-et-Vilaine
Germany	Local Institution - 0032	Buxtehude
Germany	Local Institution - 0030	Erfurt
Germany	Local Institution - 0027	Essen
Germany	Local Institution - 0033	Hannover
Germany	Local Institution - 0132	Heidelberg
Germany	Local Institution - 0074	Homburg / Saar
Germany	Local Institution - 0029	Köln
Germany	Local Institution - 0028	Lubeck
Germany	Local Institution - 0072	Mannheim
Germany	Local Institution - 0034	Muenchen
Germany	Local Institution - 0071	Quedlinburg	Sachsen-Anhalt
Germany	Local Institution - 0131	Tübingen	Baden-Württemberg
Germany	Local Institution - 0031	Wuerzburg
Greece	Local Institution - 0064	Athens
Greece	Local Institution - 0065	Thessaloniki
Israel	Local Institution - 0086	Haifa
Israel	Local Institution - 0088	Jerusalem
Israel	Local Institution - 0087	Ramat-gan
Italy	ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII	Bergamo
Italy	Local Institution - 0108	Milano
Italy	Istituto Nazionale Tumori Fondazione Pascale	Napoli
Italy	Istituto Oncologico Veneto IOV	Padova
Italy	AOUS - Policlinico S.Maria Alle Scotte	Siena
Italy	Local Institution - 0111	Torino	Piemonte
Mexico	Local Institution - 0093	Cancún	Quintana Roo
Mexico	Local Institution - 0092	Merida	Yucatan
Mexico	Local Institution - 0091	Monterrey	Nuevo LEON
Mexico	Local Institution - 0129	Veracruz
Mexico	Local Institution - 0094	Zapopan	Jalisco
New Zealand	Local Institution - 0090	Dunedin
New Zealand	Local Institution - 0125	Hamilton
New Zealand	Local Institution - 0089	Tauranga
Norway	Local Institution - 0121	Oslo
Poland	Local Institution - 0040	Poznan	Wielkopolskie
Poland	Local Institution - 0039	Warszawa
Romania	Local Institution - 0066	Bucharest
Romania	Local Institution - 0070	Cluj-Napoca	Cluj
Romania	Local Institution - 0067	Craiova
Romania	Local Institution - 0069	Iasi
Russian Federation	Local Institution - 0113	Krasnodar
Russian Federation	Local Institution - 0127	Krasnoyarsk
Russian Federation	Local Institution - 0112	Moscow
Spain	Local Institution - 0023	A Coruña
Spain	Local Institution - 0024	Barcelona
Spain	Local Institution - 0025	Barcelona
Spain	Local Institution - 0026	Madrid
Spain	Local Institution - 0021	San Sabastian Gipuzkoa
Spain	Local Institution - 0022	Sevilla
Sweden	Local Institution - 0098	Goteborg
Sweden	Local Institution - 0099	Lund
Sweden	Local Institution - 0118	Solna
Sweden	Local Institution - 0122	Uppsala
United Kingdom	Local Institution - 0052	Bristol	Avon
United Kingdom	Local Institution - 0054	Glasgow	Dumfries & Galloway
United Kingdom	Local Institution - 0126	Inverness	Inverness-shire
United Kingdom	Local Institution - 0051	London	Greater London
United Kingdom	Local Institution - 0056	Swansea	Glamorgan
United States	Local Institution - 0019	Allentown	Pennsylvania
United States	Local Institution - 0015	Ann Arbor	Michigan
United States	Local Institution - 0038	Atlanta	Georgia
United States	Local Institution - 0077	Baltimore	Maryland
United States	Local Institution - 0120	Baltimore	Maryland
United States	Local Institution - 0014	Boston	Massachusetts
United States	Local Institution - 0134	Boston	Massachusetts
United States	Local Institution - 0018	Charlotte	North Carolina
United States	Local Institution - 0016	Chicago	Illinois
United States	Local Institution - 0076	Dallas	Texas
United States	Local Institution - 0114	Fort Wayne	Indiana
United States	Local Institution - 0008	Houston	Texas
United States	Local Institution - 0013	Jacksonville	Florida
United States	Local Institution - 0020	Los Angeles	California
United States	Local Institution - 0009	Minneapolis	Minnesota
United States	Local Institution - 0117	Orlando	Florida
United States	Local Institution - 0011	Rochester	Minnesota
United States	Coastal Integrative Cancer Care	San Luis Obispo	California
United States	Local Institution - 0116	Santa Barbara	California
United States	Local Institution - 0007	Tampa	Florida
United States	Local Institution - 0010	Tucson	Arizona
United States	Local Institution - 0012	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  Colombia,  Denmark,  Finland,  France,  Germany,  Greece,  Israel,  Italy,  Mexico,  New Zealand,  Norway,  Poland,  Romania,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Number of Participants Experiencing Adverse Events (AEs)	The number of participants experiencing adverse events (AEs).; An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
Other	The Number of Participants Experiencing Serious Adverse Events (SAEs)	The number of participants experiencing serious adverse events (SAEs).; A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event.	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
Other	The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation	The number of participants experiencing adverse events (AEs) leading to discontinuation.; An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
Other	The Number of Participant Deaths in the Study	The number of participant deaths in the study.	From first dose up to approximately 33 months
Other	The Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests	The number of participants with clinical laboratory test abnormalities in specific liver tests based on US conventional units.	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
Other	The Number of Participants Experiencing Laboratory Abnormalities in Specific Thyroid Tests	The number of participants with clinical laboratory test abnormalities in specific thyroid tests based on US conventional units.	From first dose to 30 days after last dose of study therapy (up to approximately 33 months)
Primary	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.	From randomization to date of first documented tumor progression or death (up to approximately 33 months)
Secondary	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").	From randomization to the date of death (up to approximately 3 years)
Secondary	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).	From randomization up to approximately 3 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting