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OpenTrials
Completed

NCT Number: NCT05297565

A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants 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.

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Key information

Conditions

Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0038, Coffs Harbour, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nivolumab/rHuPH20

Biological

Specified dose on specified days

Other names: BMS-986298

Nivolumab

Biological

Specified dose on specified days

Other names: BMS-936558, Opdivo

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: CheckMate-6GE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2022
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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