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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06101134
Recruitment Status : Recruiting
First Posted : October 26, 2023
Last Update Posted : May 14, 2024
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: relatlimab+nivolumab Drug: relatlimab+nivolumab+rHuPH20 Drug: nivolumab Drug: nivolumab+rHuPH20 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 8, 2023
Estimated Primary Completion Date : August 29, 2025
Estimated Study Completion Date : August 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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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 Name: BMS-986298


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ) [ Time Frame: At Cycle 4 Day 1 (each cycle is 28 days) ]

Secondary Outcome Measures :
  1. Number of participants with Adverse Events (AEs) [ Time Frame: Up to approximately 2.5 years ]
  2. Number of participants with Serious AEs (SAEs) [ Time Frame: Up to approximately 2.5 years ]
  3. Number of participants with treatment-related AEs [ Time Frame: Up to approximately 2.5 years ]
  4. Number of participants with AEs leading to discontinuation [ Time Frame: Up to approximately 2.5 years ]
  5. Number of participants with Immune-mediated AEs (IMAEs) [ Time Frame: Up to approximately 2.5 years ]
  6. Number of participants with other events of special interest (OESIs) [ Time Frame: Up to approximately 2.5 years ]
  7. Number of participants with injection/infusion-related AEs [ Time Frame: Up to approximately 2.5 years ]
  8. Number of deaths [ Time Frame: Up to approximately 2.5 years ]
  9. Number of participants with laboratory abnormalities [ Time Frame: Up to approximately 2.5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06101134


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT06101134    
Other Study ID Numbers: CA224-1044
U1111-1289-5947 ( Other Identifier: WHO )
2023-504515-33-00 ( Other Identifier: EU CTR )
First Posted: October 26, 2023    Key Record Dates
Last Update Posted: May 14, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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/disclosure-commitment.html
Supporting Materials: 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/disclosure-commitment.html

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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
Keywords provided by Bristol-Myers Squibb:
rHuPH20
Patient preference
Nivolumab Relatlimab IV
Nivolumab Relatimab SC
Melanoma
FDC IV
 FDC SC
Adjuvant
Metastatic
Switch
Nivolumab
Relatlimab
Additional relevant MeSH terms:
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Melanoma
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
Nivolumab
Relatlimab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action