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

February 6, 2025 updated by: Bristol-Myers Squibb

A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection

The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • Local Institution - 0038
      • Wollongong, New South Wales, Australia, 2500
        • Local Institution - 0003
    • Victoria
      • Bendigo, Victoria, Australia, 3550
        • Local Institution - 0008
  • Belgium
      • Gent, Belgium, 9000
        • Local Institution - 0029
  • Italy
      • Milano, Italy, 20141
        • Local Institution - 0016
      • Napoli, Italy, 80131
        • Local Institution - 0015
  • Poland
      • Bydgoszcz, Poland, 85-796
        • Local Institution - 0036
    • Opolskie
      • Opole, Opolskie, Poland, 45-061
        • Local Institution - 0034
  • Spain
      • Barcelona, Spain, 08003
        • Local Institution - 0026
      • Madrid, Spain, 28036
        • Local Institution - 0002
      • Madrid, Spain, 28050
        • Local Institution - 0043
      • Sevilla, Spain, 41009
        • Local Institution - 0005
      • Valencia, Spain, 46014
        • Local Institution - 0030
  • United Kingdom
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
        • Local Institution - 0040
  • United States
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Local Institution - 0004
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Local Institution - 0044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Subcutaneous Nivolumab
Biological: Nivolumab/rHuPH20
Specified dose on specified days
Other Names:
  • BMS-986298
Active Comparator: Arm B: Intravenous Nivolumab
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • BMS-936558
  • Opdivo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: From first dose to 100 days post last dose (Approximately up to 14 Months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment.

An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
From first dose to 100 days post last dose (Approximately up to 14 Months)
Number of Participants With Serious Adverse Events
Time Frame: From first dose to 100 days post last dose (Approximately up to 14 Months)

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:

  • Results in death.
  • Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe).
  • Requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose to 100 days post last dose (Approximately up to 14 Months)
Number of Participants With Treatment Related Adverse Events
Time Frame: From first dose to 100 days post last dose (Approximately up to 14 Months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment.

An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom or disease.
From first dose to 100 days post last dose (Approximately up to 14 Months)
Number of Participants With Treatment Related Serious Adverse Events
Time Frame: From first dose to 100 days post last dose (Approximately up to 14 Months)

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:

  • Results in death.
  • Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe).
  • Requires inpatient hospitalization or causes prolongation of existing hospitalization.
From first dose to 100 days post last dose (Approximately up to 14 Months)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 15 months
Up to 15 months
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 15 months
Up to 15 months
Number of participants with treatment-related AEs
Time Frame: Up to 15 months
Up to 15 months
Number of participants with immune-mediated adverse events (IMAEs)
Time Frame: Up to 15 months
Up to 15 months
Number of participants with AEs leading to discontinuation
Time Frame: Up to 15 months
Up to 15 months
Number of participants with death
Time Frame: Up to 15 months
Up to 15 months
Number of participants with laboratory abnormalities
Time Frame: Up to 15 months
Up to 15 months
Recurrence-free survival (RFS) rates (per investigator)
Time Frame: Up to 36 months
Up to 36 months
Overall survival (OS) rates
Time Frame: Up to 36 months
Up to 36 months
Minimum nivolumab serum concentration on Day 28 (Cmind28)
Time Frame: Up to 28 days
Up to 28 days
Maximum nivolumab serum concentration after the first dose (Cmax1)
Time Frame: Up to 28 days
Up to 28 days
Time to maximum nivolumab serum concentration after the first dose (Tmax)
Time Frame: Up to 28 days
Up to 28 days
Maximum nivolumab serum concentration at steady-state (Cmaxss)
Time Frame: Up to 17 weeks
Up to 17 weeks
Time-averaged nivolumab serum concentration at steady-state (Cavgss)
Time Frame: Up to 17 weeks
Up to 17 weeks
Minimum nivolumab serum concentration at steady-state (Cminss)
Time Frame: Up to 17 weeks
Up to 17 weeks
Percentage of participants who develop anti-nivolumab antibodies
Time Frame: Up to 15 months
Up to 15 months
Percentage of participants who develop neutralizing antibodies
Time Frame: Up to 15 months
Up to 15 months
Percentage of participants with the impact of anti-nivolumab antibodies on AEs
Time Frame: Up to 15 months
Up to 15 months
Percentage of participants with administration-related reactions
Time Frame: Up to 15 months
Up to 15 months
Percentage of participants with events within MedDRA standardized MedDRA query (SMQ) anaphylactic reactions
Time Frame: Up to 15 months
Up to 15 months
Mean Cancer Treatment Satisfaction Questionnaire (CTSQ) domain scores
Time Frame: Up to 1 year
Up to 1 year
Mean CTSQ Satisfaction domain score change from baseline at each assessment time point
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Actual)

February 8, 2024

Study Completion (Actual)

February 8, 2024

Study Registration Dates

First Submitted

March 17, 2022

First Submitted That Met QC Criteria

March 17, 2022

First Posted (Actual)

March 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-6GE
  • 2021-003208-42 (EudraCT Number)
  • U1111-1266-6116 (Registry Identifier: WHO)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe