Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
Query!
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
Query!
Secondary ID [1]
0
0
2016-003729-41
Query!
Secondary ID [2]
0
0
CA209-915
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
CheckMate 915
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Melanoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Malignant melanoma
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Other interventions - nivolumab
Other interventions - ipilimumab
Experimental: nivolumab + ipilimumab - Specified Dose on Specified Days
Experimental: nivolumab - Specified Dose on Specified Days
Other interventions: nivolumab
Specified Dose on Specified Days
Other interventions: ipilimumab
Specified Dose on Specified Days
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Recurrence-free Survival (RFS) - All Randomized Participants
Query!
Assessment method [1]
0
0
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first.
Median values based on Kaplan-Meier Estimates.
Query!
Timepoint [1]
0
0
From randomization to Primary Completion Date (up to approximately 3 years)
Query!
Primary outcome [2]
0
0
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
Query!
Assessment method [2]
0
0
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first.
Median based on Kaplan-Meier Estimates.
Query!
Timepoint [2]
0
0
From randomization to Primary Completion Date (up to approximately 3 years)
Query!
Secondary outcome [1]
0
0
Overall Survival (OS) - All Randomized Participants
Query!
Assessment method [1]
0
0
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Query!
Timepoint [1]
0
0
From randomization to date of death (up to approximately 45 months)
Query!
Secondary outcome [2]
0
0
Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
Query!
Assessment method [2]
0
0
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Query!
Timepoint [2]
0
0
From randomization to date of death (up to approximately 45 months)
Query!
Secondary outcome [3]
0
0
Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
Query!
Assessment method [3]
0
0
RFS was defined as the time between the date of randomization and the date of first recurrence (local, regional or distant metastasis), new primary melanoma (including melanoma in situ), or death (from any cause), whichever occurred first.
Median based on Kaplan-Meier Estimates.
Query!
Timepoint [3]
0
0
From randomization to Study Completion Date (up to approximately 45 months)
Query!
Secondary outcome [4]
0
0
Time to Next-Line Therapies - All Randomized Participants
Query!
Assessment method [4]
0
0
Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date.
Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date.
Query!
Timepoint [4]
0
0
From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Query!
Secondary outcome [5]
0
0
Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%
Query!
Assessment method [5]
0
0
Time to next therapy was defined as the time from the date of randomization to the start date of next systemic therapy. Participants who did not receive next treatment were censored at the last known alive date.
Time to second next therapy was defined as the time from the date of randomization to the start date of second next systemic therapy. Participants who did not receive second next treatment were censored at the last known alive date
Query!
Timepoint [5]
0
0
From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Query!
Secondary outcome [6]
0
0
Time From Next Therapy to Second Next Therapy - All Randomized Participants
Query!
Assessment method [6]
0
0
Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
Query!
Timepoint [6]
0
0
From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Query!
Secondary outcome [7]
0
0
Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Query!
Assessment method [7]
0
0
Time from next treatment to second next treatment was defined as the time from the start date of next systemic therapy to start date of second next systemic therapy. No censoring rules were applied here as analysis was only performed for the subset of participants who received second next treatment.
Query!
Timepoint [7]
0
0
From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Query!
Secondary outcome [8]
0
0
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
Query!
Assessment method [8]
0
0
PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.
Query!
Timepoint [8]
0
0
From randomization to progression event (up to approximately 45 months)
Query!
Secondary outcome [9]
0
0
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Query!
Assessment method [9]
0
0
PFS2 was defined as the time from randomization to the progression date on next-line systemic therapy or the end date of next-line systemic therapy (if progression date not available) or death from any cause (if both progression date and end date not available), and to last known alive date in case of no event (ie, censoring), meaning either (1) no subsequent systemic therapy and no death OR (2) subsequent systemic therapy but no progression date nor end date available and no death.
Query!
Timepoint [9]
0
0
From randomization to progression event (up to approximately 45 months)
Query!
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)
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/04/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
2/02/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1844
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - North Sydney
Query!
Recruitment hospital [2]
0
0
Local Institution - Waratah
Query!
Recruitment hospital [3]
0
0
Local Institution - Westmead
Query!
Recruitment hospital [4]
0
0
Local Institution - Greenslopes
Query!
Recruitment hospital [5]
0
0
Local Institution - Southport
Query!
Recruitment hospital [6]
0
0
Local Institution - Woolloongabba
Query!
Recruitment hospital [7]
0
0
Local Institution - Adelaide
Query!
Recruitment hospital [8]
0
0
Local Institution - Box Hill
Query!
Recruitment hospital [9]
0
0
Local Institution - Melbourne
Query!
Recruitment hospital [10]
0
0
Local Institution - Nedlands
Query!
Recruitment hospital [11]
0
0
Local Institution - Subiaco
Query!
Recruitment postcode(s) [1]
0
0
2060 - North Sydney
Query!
Recruitment postcode(s) [2]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [3]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [4]
0
0
4120 - Greenslopes
Query!
Recruitment postcode(s) [5]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [6]
0
0
4120 - Woolloongabba
Query!
Recruitment postcode(s) [7]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [8]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [9]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [10]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [11]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [12]
0
0
6008 - Subiaco
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
District of Columbia
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Massachusetts
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Missouri
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oregon
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Tennessee
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Texas
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Utah
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Virginia
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Washington
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Graz
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Wien
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Brussels
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Bruxelles
Query!
Country [25]
0
0
Belgium
Query!
State/province [25]
0
0
Gent
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Liege
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Bahia
Query!
Country [28]
0
0
Brazil
Query!
State/province [28]
0
0
Minas Gerais
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
RIO Grande DO SUL
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Santa Catarina
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Sao Paulo
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
SAO Paulo
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Rio De Janeiro
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Rio de Janeiro
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Alberta
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
British Columbia
Query!
Country [37]
0
0
Canada
Query!
State/province [37]
0
0
Ontario
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
Quebec
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Brno
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Hradec Kralove
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Praha 10
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Praha 2
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Dijon
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
LILLE Cedex
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Marseille Cedex 5
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Nantes
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Paris
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Pierre Benite Cedex
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Toulouse Cedex 9
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Villejuif
Query!
Country [51]
0
0
Germany
Query!
State/province [51]
0
0
Berlin
Query!
Country [52]
0
0
Germany
Query!
State/province [52]
0
0
Buxtehude
Query!
Country [53]
0
0
Germany
Query!
State/province [53]
0
0
Essen
Query!
Country [54]
0
0
Germany
Query!
State/province [54]
0
0
Gera
Query!
Country [55]
0
0
Germany
Query!
State/province [55]
0
0
Hannover
Query!
Country [56]
0
0
Germany
Query!
State/province [56]
0
0
Heidelberg
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Luebeck
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Muenchen
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Tuebingen
Query!
Country [60]
0
0
Greece
Query!
State/province [60]
0
0
Athens
Query!
Country [61]
0
0
Israel
Query!
State/province [61]
0
0
Haifa
Query!
Country [62]
0
0
Israel
Query!
State/province [62]
0
0
Jerusalem
Query!
Country [63]
0
0
Israel
Query!
State/province [63]
0
0
Tel Hashomer
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Bergamo
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Genova
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Milano
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Napoli
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Padova
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Siena
Query!
Country [70]
0
0
New Zealand
Query!
State/province [70]
0
0
BAY OF Plenty
Query!
Country [71]
0
0
New Zealand
Query!
State/province [71]
0
0
Christchurch
Query!
Country [72]
0
0
New Zealand
Query!
State/province [72]
0
0
Dunedin
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Krakow
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Warszawa
Query!
Country [75]
0
0
Romania
Query!
State/province [75]
0
0
Bucharest
Query!
Country [76]
0
0
Romania
Query!
State/province [76]
0
0
Craiova
Query!
Country [77]
0
0
Russian Federation
Query!
State/province [77]
0
0
Krasnodar
Query!
Country [78]
0
0
Russian Federation
Query!
State/province [78]
0
0
Krasnoyarsk
Query!
Country [79]
0
0
Russian Federation
Query!
State/province [79]
0
0
Moscow
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Badalona-barcelona
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Barcelona
Query!
Country [82]
0
0
Spain
Query!
State/province [82]
0
0
Madrid
Query!
Country [83]
0
0
Spain
Query!
State/province [83]
0
0
Malaga
Query!
Country [84]
0
0
Spain
Query!
State/province [84]
0
0
Sevilla
Query!
Country [85]
0
0
Spain
Query!
State/province [85]
0
0
Valencia
Query!
Country [86]
0
0
Switzerland
Query!
State/province [86]
0
0
Lausanne
Query!
Country [87]
0
0
Switzerland
Query!
State/province [87]
0
0
Zuerich
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
Oxfordshire
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
Glasgow
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
London
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Manchester
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Sutton.
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bristol-Myers Squibb
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03068455
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bristol-Myers Squibb
Query!
Address
0
0
Bristol-Myers Squibb
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03068455
Download to PDF