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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
1/03/2024

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 (AEs)
Timepoint [1] 0 0
Up to 15 months
Primary outcome [2] 0 0
Number of participants with serious adverse events (SAEs)
Timepoint [2] 0 0
Up to 15 months
Primary outcome [3] 0 0
Number of participants with treatment-related AEs
Timepoint [3] 0 0
Up to 15 months
Primary outcome [4] 0 0
Number of participants with treatment-related SAEs
Timepoint [4] 0 0
Up to 15 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
3/08/2022
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
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.
Trial website
https://clinicaltrials.gov/study/NCT05297565
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05297565