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

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: Melanoma
• Intervention / Treatment: Drug: nivolumab; Drug: relatlimab+nivolumab; Drug: relatlimab+nivolumab+rHuPH20; Drug: nivolumab+rHuPH20

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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		From first dose (Day 1) and up to study completion (up to approximately 45 months)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): April 10, 2025
• Study Completion (Estimated): February 26, 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): August 19, 2026
• Last Update Submitted That Met QC Criteria: July 27, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Nivolumab; Metastatic; Melanoma; Adjuvant; Relatlimab; Switch; Patient preference; rHuPH20; Nivolumab Relatlimab IV; Nivolumab Relatimab SC; FDC IV; FDC SC
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplastic Processes; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Pathological Conditions, Signs and Symptoms; Behavior; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction; Neoplasm Metastasis; Melanoma; Patient Preference; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nivolumab; Opdualag
• 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