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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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06101134
Collaborator
(none)
100
Enrollment
29
Locations
2
Arms
44.1
Anticipated Duration (Months)
3.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Dec 29, 2023
Anticipated Primary Completion Date :
Aug 29, 2025
Anticipated Study Completion Date :
Aug 31, 2027

Arms and Interventions

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

    		•

    Outcome Measures

    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) [At Cycle 4 Day 1 (each cycle is 28 days)]

    Secondary Outcome Measures

    1. Number of participants with Adverse Events (AEs) [Up to approximately 2.5 years]

    2. Number of participants with Serious AEs (SAEs) [Up to approximately 2.5 years]

    3. Number of participants with treatment-related AEs [Up to approximately 2.5 years]

    4. Number of participants with AEs leading to discontinuation [Up to approximately 2.5 years]

    5. Number of participants with Immune-mediated AEs (IMAEs) [Up to approximately 2.5 years]

    6. Number of participants with other events of special interest (OESIs) [Up to approximately 2.5 years]

    7. Number of participants with injection/infusion-related AEs [Up to approximately 2.5 years]

    8. Number of deaths [Up to approximately 2.5 years]

    9. Number of participants with laboratory abnormalities [Up to approximately 2.5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Alaska Oncology & Hematology, LLC Anchorage Alaska United States 99508-2974
    2 Mayo Clinic Hospital - Phoenix Phoenix Arizona United States 85054-4502
    3 University of California, San Francisco, Medical Center at Mount Zion San Francisco California United States 94115-3010
    4 University of New Mexico Cancer Center Albuquerque New Mexico United States 87106
    5 Icahn School of Medicine at Mount Sinai (ISMMS) - The Derald H. Ruttenberg Treatment Center New York New York United States 10029-6542
    6 Local Institution - 0024 Cipolletti R Argentina 8324
    7 Local Institution - 0002 Viedma R Argentina R8500JYJ
    8 Local Institution - 0001 Rosario S Argentina 2000
    9 Local Institution - 0015 Las Condes Santiago Chile 8331010
    10 Local Institution - 0005 Concepcion Chile 4070196
    11 Local Institution - 0016 Las Condes Chile 7550000
    12 Local Institution - 0019 Thessaloniki B Greece 546 22
    13 Local Institution - 0014 Athens I Greece 115 27
    14 Local Institution - 0029 Marousi I Greece 151 25
    15 Local Institution - 0023 Holargos, Athens Greece 155 62
    16 Local Institution - 0008 Peiraias Greece 185 47
    17 Local Institution - 0017 Bergamo BG Italy 24127
    18 Local Institution - 0018 Milan MI Italy 20141
    19 Local Institution - 0012 Padova PD Italy 35128
    20 Local Institution - 0021 Roma RM Italy 00144
    21 Local Institution - 0004 Torino TO Italy 10126
    22 Local Institution - 0026 Napoli Italy 80130
    23 Local Institution - 0011 Barcelona B Spain 08025
    24 Local Institution - 0022 Barcelona B Spain 08908
    25 Local Institution - 0009 Cartagena MU Spain 30120
    26 Local Institution - 0020 Badalona Spain 08916
    27 Local Institution - 0027 Cantabria Spain 39008
    28 Local Institution - 0003 San Pedro Alcántara, Málaga Spain 10002
    29 Local Institution - 0006 Sevilla Spain 41013

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT06101134
    Other Study ID Numbers:
    • CA224-1044
    • U1111-1289-5947
    • 2023-504515-33-00
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Patient preference
    Nivolumab Relatlimab IV
    Nivolumab Relatimab SC
    Melanoma
    rHuPH20
    FDC IV
    FDC SC
    Adjuvant
    Metastatic
    Switch
    Nivolumab
    Relatlimab
    Additional relevant MeSH terms:
    Melanoma
    Nivolumab
    Relatlimab

    Study Results

    No Results Posted as of Oct 26, 2023