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A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection (CheckMate-6GE)

  • Clinicaltrials.gov identifier

    NCT05297565

  • Recruitment Status

    Recruiting

  • First Posted

    March 28, 2022

  • Last update posted

    May 16, 2022

Study Description

Brief summary:

The purpose of this study is to compare the drug levels of nivolumab administered subcutaneously versus intravenous administration in participants with melanoma following complete resection.

  • Condition or Disease:Melanoma
  • Intervention/Treatment: Biological: Nivolumab/rHuPH20
    Biological: Nivolumab
  • Phase: Phase 3

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 286 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
  • Estimated Study Start Date: May 2022
  • Estimated Primary Completion Date: December 2023
  • Estimated Study Completion Date: August 2026

Arms and interventions

Arm Intervention/treatment
Experimental: Part 1 Arm A: Subcutaneous Nivolumab
Biological: Nivolumab/rHuPH20
Specified dose on specified days
Experimental: Part 2: Subcutaneous Nivolumab
Biological: Nivolumab/rHuPH20
Specified dose on specified days
Active Comparator: Part 1 Arm B: Intravenous Nivolumab
Biological: Nivolumab
Specified dose on specified days

Outcome Measures

  • Primary Outcome Measures: 1. Time-averaged nivolumab serum concentration over the first 28 days (Cavgd28) [ Time Frame: Up to 28 days ]
  • 2. Minimum nivolumab serum concentration at steady-state (Cminss) [ Time Frame: Up to 28 days ]
  • Secondary Outcome Measures: 1. Number of participants with adverse events (AEs) [ Time Frame: Up to 15 months ]
  • 2. Number of participants with serious adverse events (SAEs) [ Time Frame: Up to 15 months ]
  • 3. Number of participants with treatment-related AEs [ Time Frame: Up to 15 months ]
  • 4. Number of participants with immune-mediated adverse events (IMAEs) [ Time Frame: Up to 15 months ]
  • 5. Number of participants with AEs leading to discontinuation [ Time Frame: Up to 15 months ]
  • 6. Number of participants with death [ Time Frame: Up to 15 months ]
  • 7. Number of participants with laboratory abnormalities [ Time Frame: Up to 15 months ]
  • 8. Recurrence-free survival (RFS) rates (per investigator) [ Time Frame: Up to 36 months ]
  • 9. Overall survival (OS) rates [ Time Frame: Up to 36 months ]
  • 10. Minimum nivolumab serum concentration on Day 28 (Cmind28) [ Time Frame: Up to 28 days ]
  • 11. Maximum nivolumab serum concentration after the first dose (Cmax1) [ Time Frame: Up to 28 days ]
  • 12. Time to maximum nivolumab serum concentration after the first dose (Tmax) [ Time Frame: Up to 28 days ]
  • 13. Maximum nivolumab serum concentration at steady-state (Cmaxss) [ Time Frame: Up to 17 weeks ]
  • 14. Time-averaged nivolumab serum concentration at steady-state (Cavgss) [ Time Frame: Up to 17 weeks ]
  • 15. Minimum nivolumab serum concentration at steady-state (Cminss) [ Time Frame: Up to 17 weeks ]
  • 16. Percentage of participants who develop anti-nivolumab antibodies [ Time Frame: Up to 15 months ]
  • 17. Percentage of participants who develop neutralizing antibodies [ Time Frame: Up to 15 months ]
  • 18. Percentage of participants with the impact of anti-nivolumab antibodies on AEs [ Time Frame: Up to 15 months ]
  • 19. Percentage of participants with administration-related reactions [ Time Frame: Up to 15 months ]
  • 20. Percentage of participants with events within MedDRA standardized MedDRA query (SMQ) anaphylactic reactions [ Time Frame: Up to 15 months ]
  • 21. Mean Cancer Treatment Satisfaction Questionnaire (CTSQ) domain scores [ Time Frame: Up to 1 year ]
  • 22. Mean CTSQ Satisfaction domain score change from baseline at each assessment time point [ Time Frame: Up to 1 year ]

Eligibility Criteria

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

Criteria

Inclusion Criteria: Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins Complete resection performed within 12 weeks prior to randomization or treatment assignment Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 Exclusion Criteria: History of uveal or mucosal melanoma Untreated/unresected CNS metastases or leptomeningeal metastases Active, known or suspected autoimmune disease Serious or uncontrolled medical disorder 4 weeks prior to screening Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible Prior immunotherapy treatments for any prior malignancies are not permitted Other protocol-defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com

Contact: First line of email MUST contain NCT # and Site #.

Locations

United States, Indiana
Ft. Wayne Medical Oncology and Hematology
Fort Wayne

Spain
Local Institution - 0001
Barcelona

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More Information

  • Responsible Party: Bristol-Myers Squibb
  • ClinicalTrials.gov Identifier: NCT05297565 History of Changes
  • Other Study ID Numbers: CA209-6GE, 2021-003208-42, U1111-1266-6116
  • First Posted: March 28, 2022 Key Record Dates
  • Last Update Posted: May 16, 2022
  • Last Verified: May 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Bristol-Myers Squibb: Skin Cancer
    rHuPH20
    OPDIVO®
  • Additional relevant MeSH terms: Melanoma
    Neuroendocrine Tumors
    Neuroectodermal Tumors
    Neoplasms, Germ Cell and Embryonal
    Neoplasms by Histologic Type
    Neoplasms
    Neoplasms, Nerve Tissue
    Nevi and Melanomas