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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03068455




Registration number
NCT03068455
Ethics application status
Date submitted
27/02/2017
Date registered
1/03/2017
Date last updated
20/09/2021

Titles & IDs
Public title
An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
Scientific title
A Phase 3, Randomized Study of Adjuvant Immunotherapy With Nivolumab Combined With Ipilimumab Versus Nivolumab Monotherapy After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma
Secondary ID [1] 0 0
2016-003729-41
Secondary ID [2] 0 0
CA209-915
Universal Trial Number (UTN)
Trial acronym
CheckMate 915
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
Description of intervention(s) / exposure
Treatment: Other - nivolumab
Treatment: Other - ipilimumab

Experimental: nivolumab + ipilimumab - Specified Dose on Specified Days

Experimental: nivolumab - Specified Dose on Specified Days


Treatment: Other: nivolumab
Specified Dose on Specified Days

Treatment: Other: ipilimumab
Specified Dose on Specified Days
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recurrence-free Survival (RFS) - All Randomized Participants
Timepoint [1] 0 0
From randomization to Primary Completion Date (up to approximately 3 years)
Primary outcome [2] 0 0
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
Timepoint [2] 0 0
From randomization to Primary Completion Date (up to approximately 3 years)
Secondary outcome [1] 0 0
Overall Survival (OS) - All Randomized Participants
Timepoint [1] 0 0
From randomization to date of death (up to approximately 45 months)
Secondary outcome [2] 0 0
Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
Timepoint [2] 0 0
From randomization to date of death (up to approximately 45 months)
Secondary outcome [3] 0 0
Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
Timepoint [3] 0 0
From randomization to Study Completion Date (up to approximately 45 months)
Secondary outcome [4] 0 0
Time to Next-Line Therapies - All Randomized Participants
Timepoint [4] 0 0
From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Secondary outcome [5] 0 0
Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%
Timepoint [5] 0 0
From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Secondary outcome [6] 0 0
Time From Next Therapy to Second Next Therapy - All Randomized Participants
Timepoint [6] 0 0
From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Secondary outcome [7] 0 0
Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Timepoint [7] 0 0
From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Secondary outcome [8] 0 0
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
Timepoint [8] 0 0
From randomization to progression event (up to approximately 45 months)
Secondary outcome [9] 0 0
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Timepoint [9] 0 0
From randomization to progression event (up to approximately 45 months)

Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com



* Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of participation in study.
* Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
* No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s) and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for central nervous system (CNS) lesions)
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of uveal melanoma
* Patients with active, known or suspected autoimmune disease
* Prior treatment with interferon (if complete < 6 months prior to participation in study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways

Other protocol defined inclusion/exclusion criteria could 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
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
11/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/02/2021
Sample size
Target
Accrual to date
Final
1844
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - North Sydney
Recruitment hospital [2] 0 0
Local Institution - Waratah
Recruitment hospital [3] 0 0
Local Institution - Westmead
Recruitment hospital [4] 0 0
Local Institution - Greenslopes
Recruitment hospital [5] 0 0
Local Institution - Southport
Recruitment hospital [6] 0 0
Local Institution - Woolloongabba
Recruitment hospital [7] 0 0
Local Institution - Adelaide
Recruitment hospital [8] 0 0
Local Institution - Box Hill
Recruitment hospital [9] 0 0
Local Institution - Melbourne
Recruitment hospital [10] 0 0
Local Institution - Nedlands
Recruitment hospital [11] 0 0
Local Institution - Subiaco
Recruitment postcode(s) [1] 0 0
2060 - North Sydney
Recruitment postcode(s) [2] 0 0
2298 - Waratah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
4120 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3000 - Melbourne
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
6009 - Nedlands
Recruitment postcode(s) [12] 0 0
6008 - Subiaco
Recruitment outside Australia
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United States of America
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Arizona
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Oregon
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Pennsylvania
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Tennessee
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Washington
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Graz
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Brussels
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Bruxelles
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Bahia
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Dijon
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Gera
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Luebeck
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Muenchen
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Lausanne
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Switzerland
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Zuerich
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United Kingdom
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Oxfordshire
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Glasgow
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London
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Manchester
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United Kingdom
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Sutton.

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 determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma
Trial website
https://clinicaltrials.gov/study/NCT03068455
Trial related presentations / publications
Weber JS, Schadendorf D, Del Vecchio M, Larkin J, Atkinson V, Schenker M, Pigozzo J, Gogas H, Dalle S, Meyer N, Ascierto PA, Sandhu S, Eigentler T, Gutzmer R, Hassel JC, Robert C, Carlino MS, Di Giacomo AM, Butler MO, Munoz-Couselo E, Brown MP, Rutkowski P, Haydon A, Grob JJ, Schachter J, Queirolo P, de la Cruz-Merino L, van der Westhuizen A, Menzies AM, Re S, Bas T, de Pril V, Braverman J, Tenney DJ, Tang H, Long GV. Adjuvant Therapy of Nivolumab Combined With Ipilimumab Versus Nivolumab Alone in Patients With Resected Stage IIIB-D or Stage IV Melanoma (CheckMate 915). J Clin Oncol. 2023 Jan 20;41(3):517-527. doi: 10.1200/JCO.22.00533. Epub 2022 Sep 26.
Yoshino T, Oki E, Misumi T, Kotaka M, Manaka D, Eto T, Hasegawa J, Takagane A, Nakamura M, Kato T, Munemoto Y, Nakamura F, Bando H, Taniguchi H, Sakamoto Y, Shiozawa M, Nishi M, Horiuchi T, Yamagishi H, Sakamoto J, Mizushima T, Ohtsu A, Mori M. Final Analysis of 3 Versus 6 Months of Adjuvant Oxaliplatin and Fluoropyrimidine-Based Therapy in Patients With Stage III Colon Cancer: The Randomized Phase III ACHIEVE Trial. J Clin Oncol. 2022 Oct 10;40(29):3419-3429. doi: 10.1200/JCO.21.02628. Epub 2022 May 5.
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/NCT03068455