A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations

March 31, 2026 updated by: Bristol-Myers Squibb

A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma

The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Concepción, Chile, 4070196
        • Local Institution - 0005
    • Santiago Metropolitan
      • Las Condes, Santiago Metropolitan, Chile, 8331010
        • Local Institution - 0015
  • Greece
      • Holargos, Athens, Greece, 155 62
        • Local Institution - 0023
      • Piraeus, Greece, 185 47
        • Local Institution - 0008
      • Thessaloniki, Greece, 564 29
        • Local Institution - 0033
    • B
      • Thessaloniki, B, Greece, 546 22
        • Local Institution - 0019
    • I
      • Athens, I, Greece, 115 27
        • Local Institution - 0014
      • Marousi, I, Greece, 151 25
        • Local Institution - 0029
  • Italy
      • Naples, Italy, 80131
        • Local Institution - 0026
    • BG
      • Bergamo, BG, Italy, 24127
        • Local Institution - 0017
    • FC
      • Meldola, FC, Italy, 47014
        • Local Institution - 0035
    • MI
      • Milan, MI, Italy, 20141
        • Local Institution - 0018
    • PD
      • Padova, PD, Italy, 35128
        • Local Institution - 0012
    • RM
      • Roma, RM, Italy, 00144
        • Local Institution - 0021
    • TO
      • Torino, TO, Italy, 10126
        • Local Institution - 0004
  • Spain
      • Badalona, Spain, 08916
        • Local Institution - 0020
      • Cantabria, Spain, 39008
        • Local Institution - 0027
      • San Pedro Alcántara, Málaga, Spain, 10002
        • Local Institution - 0003
      • Seville, Spain, 41013
        • Local Institution - 0006
    • B
      • Barcelona, B, Spain, 08025
        • Local Institution - 0011
      • Barcelona, B, Spain, 08908
        • Local Institution - 0022
    • MU
      • Cartagena, MU, Spain, 30120
        • Local Institution - 0009
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508-2974
        • Local Institution - 0007
    • Arizona
      • Phoenix, Arizona, United States, 85054-4502
        • Local Institution - 0013
    • California
      • San Francisco, California, United States, 94115-3010
        • Local Institution - 0010
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Institution - 0034
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Local Institution - 0032
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Local Institution - 0028
    • Washington
      • Edmonds, Washington, United States, 98026-8032
        • Local Institution - 0037
      • Issaquah, Washington, United States, 98026
        • Local Institution - 0036
      • Seattle, Washington, United States, 98104
        • Local Institution - 0030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease
  • Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma

Exclusion Criteria:

  • Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)

Other protocol-defined inclusion/exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Metastatic Melanoma
Drug: relatlimab+nivolumab
Specified dose on specified days
Other Names:
  • BMS-986213
  • Opdualag
Drug: relatlimab+nivolumab+rHuPH20
Specified dose on specified days
Experimental: Cohort 2: Resected Melanoma
Drug: nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo
Drug: nivolumab+rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986298

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Evaluable Participants That Prefer SC Route of Administration Using the Patient Experience and Preference Questionnaire (PEPQ) (Question 7) After Cycle 4 Day 1 Dose
Time Frame: Cycle 4 Day 1 (each cycle consist of 4 weeks)
PEPQ included 7 items 1. Pain or Discomfort (rated on 1 to 10 scale), 2. Length of time related to administration 3. Length of time related to administration impact amount of time to speak to doctor or nurse about illness or concern 4. Length of time for administration impact time to interact or socialize with other individuals 5. Convenience 6. Satisfaction 7. Choice of which route of administration would be preferred. 95% CI exact confidence interval was reported.
Cycle 4 Day 1 (each cycle consist of 4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events and Deaths
Time Frame: First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months)
An adverse event is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.
First dose (Day 1) and 30 days after last dose of study therapy (up to approximately 16 months)
Number of Participants With Laboratory Abnormalities and Immune Mediate Adverse Event
Time Frame: From first dose (Day 1) and up to study completion (up to approximately 45 months)
From first dose (Day 1) and up to study completion (up to approximately 45 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Actual)

April 10, 2025

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA224-1044
  • U1111-1289-5947 (Other Identifier: WHO)
  • 2023-504515-33-00 (Other Identifier: EU CTR)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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