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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Melanoma

Treatments

Biological: Nivolumab/rHuPH20

Biological: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05297565

CA209-6GE

2021-003208-42 (EudraCT Number)

U1111-1266-6116 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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