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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05297565




Registration number
NCT05297565
Ethics application status
Date submitted
17/03/2022
Date registered
28/03/2022
Date last updated
25/03/2025

Titles & IDs
Public title
A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
Scientific 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
Secondary ID [1] 0 0
2021-003208-42
Secondary ID [2] 0 0
CA209-6GE
Universal Trial Number (UTN)
Trial acronym
CheckMate-6GE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Other - Nivolumab/rHuPH20
Treatment: Other - Nivolumab

Experimental: Arm A: Subcutaneous Nivolumab -

Active comparator: Arm B: Intravenous Nivolumab -


Treatment: Other: Nivolumab/rHuPH20
Specified dose on specified days

Treatment: Other: Nivolumab
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
From first dose to 100 days post last dose (Approximately up to 14 Months)
Primary outcome [2] 0 0
Number of Participants With Serious Adverse Events
Timepoint [2] 0 0
From first dose to 100 days post last dose (Approximately up to 14 Months)
Primary outcome [3] 0 0
Number of Participants With Treatment Related Adverse Events
Timepoint [3] 0 0
From first dose to 100 days post last dose (Approximately up to 14 Months)
Primary outcome [4] 0 0
Number of Participants With Treatment Related Serious Adverse Events
Timepoint [4] 0 0
From first dose to 100 days post last dose (Approximately up to 14 Months)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/02/2024
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 0038 - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - 0003 - Wollongong
Recruitment hospital [3] 0 0
Local Institution - 0008 - Bendigo
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
3550 - Bendigo
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Indiana
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
Belgium
State/province [3] 0 0
Gent
Country [4] 0 0
Italy
State/province [4] 0 0
Milano
Country [5] 0 0
Italy
State/province [5] 0 0
Napoli
Country [6] 0 0
Poland
State/province [6] 0 0
Opolskie
Country [7] 0 0
Poland
State/province [7] 0 0
Bydgoszcz
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Spain
State/province [10] 0 0
Sevilla
Country [11] 0 0
Spain
State/province [11] 0 0
Valencia
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Leicestershire

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT05297565