A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose... | NCT05625399

Studies
A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

NCT05625399

Sponsor

Bristol-Myers Squibb

Status

Active, not recruiting

Last Update Posted

Jun 3, 2026Actual

Enrollment

579Actual

Phase

Phase 3

Conditions

Melanoma

Interventions

Nivolumab + Relatlimab
rHuPH20

Countries

United States
Australia
Austria
Belgium
Brazil
Canada
Chile
Czechia
Finland
France
Germany
Israel
Italy
Norway
Poland
Spain
Sweden
Switzerland
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
U1111-1274-0193	Other Identifier	WHO
2022-500967-11-00	Other Identifier	EU CTR

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2023Actual

Primary Completion Date

Aug 4, 2025Actual

Completion Date

Nov 18, 2027Estimated

First Submitted Date

Nov 15, 2022

First Submission Date that Met QC Criteria

Nov 15, 2022

First Posted Date

Nov 22, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2026

Last Update Posted Date

Jun 3, 2026Actual

Name	Class
Halozyme Therapeutics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to demonstrate that the study drug exposure level of the nivolumab + relatlimab FDC subcutaneous (SC) formulation is not worse than nivolumab + relatlimab FDC intravenous (IV) administration in participants with previously untreated metastatic or unresectable melanoma.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

579Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nivolumab + Relatlimab FDC SC	Experimental		Drug: Nivolumab + Relatlimab Drug: rHuPH20
Nivolumab + Relatlimab FDC IV	Active Comparator		Drug: Nivolumab + Relatlimab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab + Relatlimab	Drug	Specified dose on specified days	Nivolumab + Relatlimab FDC IV Nivolumab + Relatlimab FDC SC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time-averaged serum concentration over 28 days after the first dose (Cavgd28) of Nivolumab		Up to 28 days
Trough serum concentration at steady state (Cminss) of Nivolumab		Up to 4 months
Cavgd28 of Relatlimab		Up to 28 days
Cminss of Relatlimab		Up to 4 months

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) per RECIST v1.1		Up to approximately 3 years
Trough serum concentration at Day 28 after the first dose (Cmind28) of Nivolumab and Relatlimab		Up to 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1/Lansky Performance Score ≥ 80% for adolescents (≥ 12 to < 18 years of age).
Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the American Joint Committee for Cancer (AJCC) staging system.
Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
Participants must be ≥ 12 years of age. Participants who are ≥ 12 years of age and < 18 years of age (adolescents) must weigh ≥ 40 kg at the time of signing the informed consent (assent).
Participants must have histologically confirmed Stage III (unresectable) or Stage IV (metastatic) melanoma, per the AJCC staging system (8th edition).

Exclusion Criteria

Participants must not have ocular melanoma.
Participants must not have a history of myocarditis, regardless of etiology.
Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 milligrams [mg] daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses >10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
Other protocol-defined Inclusion/Exclusion criteria apply.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution - 0125		Phoenix	Arizona	85013	United States
Local Institution - 0189

Label	URL
BMS Clinical Trial Information	View source
BMS Clinical Trial Patient Recruiting	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Types

Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

See Plan Description

Access Criteria

See Plan Description

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D009380	Neoplasms, Nerve Tissue
D018326	Nevi and Melanomas
D012878	Skin Neoplasms
D009371	Neoplasms by Site
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D000077594	Nivolumab
C000721227	relatlimab
C000729737	Opdualag

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins