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

NCT06101134 | Active Not Recruiting Phase 2 Results FDA Drug

• 3 other identifiers: CA224-1044U1111-1289-59472023-504515-33-00
• Study Type: interventional
• Target: 100
• Locations: 5 countries
• Sites: 31

Brief Summary

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.

Conditions

Melanoma

Keywords

Patient preference; Nivolumab Relatlimab IV; Nivolumab Relatimab SC; Melanoma; rHuPH20; FDC IV; FDC SC; Adjuvant; Metastatic; Switch; Nivolumab; Relatlimab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants With Adverse Events and Deaths

  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)

Study Arms (2)

Cohort 1: Metastatic Melanoma

EXPERIMENTAL

Drug: relatlimab+nivolumab; Drug: relatlimab+nivolumab+rHuPH20

Cohort 2: Resected Melanoma

EXPERIMENTAL

Drug: nivolumab; Drug: nivolumab+rHuPH20

Interventions

relatlimab+nivolumab DRUG

Specified dose on specified days

Also known as: BMS-986213, Opdualag

Cohort 1: Metastatic Melanoma

relatlimab+nivolumab+rHuPH20 DRUG

Specified dose on specified days

Cohort 1: Metastatic Melanoma

nivolumab DRUG

Specified dose on specified days

Also known as: BMS-936558, Opdivo

Cohort 2: Resected Melanoma

nivolumab+rHuPH20 DRUG

Specified dose on specified days

Also known as: BMS-986298

Cohort 2: Resected Melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (31)

Local Institution - 0007

Anchorage, Alaska, 99508-2974, United States

Location

Local Institution - 0013

Phoenix, Arizona, 85054-4502, United States

Location

Local Institution - 0010

San Francisco, California, 94115-3010, United States

Location

Local Institution - 0034

Atlanta, Georgia, 30342, United States

Location

Local Institution - 0032

Edgewood, Kentucky, 41017, United States

Location

Local Institution - 0028

Albuquerque, New Mexico, 87106, United States

Location

Local Institution - 0037

Edmonds, Washington, 98026-8032, United States

Location

Local Institution - 0036

Issaquah, Washington, 98026, United States

Location

Local Institution - 0030

Seattle, Washington, 98104, United States

Location

Local Institution - 0015

Las Condes, Santiago Metropolitan, 8331010, Chile

Location

Local Institution - 0005

Concepción, 4070196, Chile

Location

Local Institution - 0019

Thessaloniki, B, 546 22, Greece

Location

Local Institution - 0014

Athens, I, 115 27, Greece

Location

Local Institution - 0029

Marousi, I, 151 25, Greece

Location

Local Institution - 0023

Holargos, Athens, 155 62, Greece

Location

Local Institution - 0008

Piraeus, 185 47, Greece

Location

Local Institution - 0033

Thessaloniki, 564 29, Greece

Location

Local Institution - 0017

Bergamo, BG, 24127, Italy

Location

Local Institution - 0035

Meldola, FC, 47014, Italy

Location

Local Institution - 0018

Milan, MI, 20141, Italy

Location

Local Institution - 0012

Padova, PD, 35128, Italy

Location

Local Institution - 0021

Roma, RM, 00144, Italy

Location

Local Institution - 0004

Torino, TO, 10126, Italy

Location

Local Institution - 0026

Naples, 80131, Italy

Location

Local Institution - 0011

Barcelona, B, 08025, Spain

Location

Local Institution - 0022

Barcelona, B, 08908, Spain

Location

Local Institution - 0009

Cartagena, MU, 30120, Spain

Location

Local Institution - 0020

Badalona, 08916, Spain

Location

Local Institution - 0027

Cantabria, 39008, Spain

Location

Local Institution - 0003

San Pedro Alcántara, Málaga, 10002, Spain

Location

Local Institution - 0006

Seville, 41013, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Melanoma; Patient Preference; Neoplasm Metastasis

Interventions

Opdualag; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 26, 2023
• Study Start: November 6, 2023
• Primary Completion: April 10, 2025
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IT (7); CL (2); ES (7); GR (6); US (9)