Back to resultsAn 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 (CheckMate 915)
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
nivolumab
ipilimumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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)
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
Sites / Locations
- University of Arizona Cancer Center
- The Angeles Clinic & Research Institute
- California Pacific Medical Center
- University Of Colorado
- Georgetown University Med Ctr
- Mount Sinai Comprehensive Cancer Center
- UF Health Cancer Center at Orlando Health
- H. Lee Moffitt Cancer Center
- Winship Cancer Institute
- University Of Chicago
- Northwestern University
- Oncology Specialists, S.C.
- Mass General Hospital
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
- University Of Michigan Health System
- Virginia Piper Cancer Institute
- Mayo Clinic Rochester
- Washington University School Of Medicine
- NYU Langone Medical Center
- Memorial Sloan Kettering Nassau
- Carolinas Med Ctr
- Duke University Medical Center
- Providence Cancer Center Oncology And Hematology Care
- Oregon Health & Science University
- St. Luke's University Health Network
- Local Institution
- Texas Oncology Sammons Cancer Center
- Md Anderson Can Cnt
- Huntsman Cancer Institute
- University Of Virginia Health System
- Inova Melanoma and Skin Cancer Center
- University Of Washington Cancer Care Alliance
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Princess Margaret Cancer Centre
- Local Institution
- Local Institution
- CHU de Quebec - Universite Laval
- Klinika komplexni onkologicke pece
- Klinika onkologie a radioterapie
- Dermatovenerologicka klinika 3. LF UK a FNKV
- Dermatovenerologicka klinika VFN a 1. LF UK
- Centre Hospitalier Universitaire Dijon Bocage
- Hopital Claude Huriez
- Hopital De La Timone
- Chu Nantes
- Hopital Saint Louis
- Centre Hospitalier Lyon Sud
- Institut Claudius Regaud
- Institut Gustave Roussy
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Laiko Hospital
- Metropolitan Hospital
- Local Institution
- Local Institution
- Local Institution
- ASST Papa Giovanni XXIII
- Ospedale Policlinico San Martino
- IRCCS Istituto Nazionale Tumori Milano
- Istituto Nazionale Tumori Fondazione Pascale
- Istituto Oncologico Veneto IOV
- Azienda Ospedaliera Universitaria Senese
- Local Institution
- Local Institution
- Local Institution
- Klinika Nowotworow Ukladowych i Uogolnionych
- Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
- Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha
- Sf. Nectarie Oncology Center
- Local Institution
- Local Institution
- Local Institution
- Hospital Universitari Germans Trias I Pujol
- H. Univ. Vall dHebron
- Hospital Clinic I Provincial
- Hospital Gral. Univ. Gregorio Maranon
- Hospital Regional Universitario De Malaga
- Hosp Univ Virgen Macarena
- Hospital Universitario Y Politecnico La Fe
- Local Institution
- Local Institution
- Local Institution
- The Beatson West Of Scotland Cancer Centre
- The Royal Marsden Hospital
- Christie Hospital Nhs Trust
- Royal Marsden Hospital - Surrey
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
nivolumab + ipilimumab
nivolumab
Arm Description
Specified Dose on Specified Days
Specified Dose on Specified Days
Outcomes
Primary Outcome Measures
Recurrence-free Survival (RFS) - All Randomized Participants
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.
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
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.
Secondary Outcome Measures
Overall Survival (OS) - All Randomized Participants
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
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.
Time to Next-Line Therapies - All Randomized Participants
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.
Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%
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
Time From Next Therapy to Second Next Therapy - All Randomized Participants
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.
Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
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.
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
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.
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
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.
Full Information
NCT ID
NCT03068455
First Posted
February 27, 2017
Last Updated
August 24, 2021
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT03068455
Brief 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
Acronym
CheckMate 915
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
February 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1844 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nivolumab + ipilimumab
Arm Type
Experimental
Arm Description
Specified Dose on Specified Days
Arm Title
nivolumab
Arm Type
Experimental
Arm Description
Specified Dose on Specified Days
Intervention Type
Biological
Intervention Name(s)
nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified Dose on Specified Days
Intervention Type
Biological
Intervention Name(s)
ipilimumab
Other Intervention Name(s)
Yervoy, BMS-734016
Intervention Description
Specified Dose on Specified Days
Primary Outcome Measure Information:
Title
Recurrence-free Survival (RFS) - All Randomized Participants
Description
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.
Time Frame
From randomization to Primary Completion Date (up to approximately 3 years)
Title
Recurrence-free Survival (RFS) - All Randomized Participants With PD-L1 Expression Level < 1%
Description
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.
Time Frame
From randomization to Primary Completion Date (up to approximately 3 years)
Secondary Outcome Measure Information:
Title
Overall Survival (OS) - All Randomized Participants
Description
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Time Frame
From randomization to date of death (up to approximately 45 months)
Title
Overall Survival (OS) - All Randomized Participants With PD-L1 Expression Level < 1%
Description
OS is defined as the time between the date of randomization and the date of death. Median based on Kaplan-Meier Estimates.
Time Frame
From randomization to date of death (up to approximately 45 months)
Title
Recurrence-free Survival (RFS) by Baseline Tumor PD-L1 Expression
Description
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.
Time Frame
From randomization to Study Completion Date (up to approximately 45 months)
Title
Time to Next-Line Therapies - All Randomized Participants
Description
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.
Time Frame
From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Title
Time to Next-Line Therapies - All Randomized Participants With PD-L1 Expression Level < 1%
Description
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
Time Frame
From randomization to start of next therapy or second next therapy (up to approximately 45 months)
Title
Time From Next Therapy to Second Next Therapy - All Randomized Participants
Description
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.
Time Frame
From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Title
Time From Next Therapy to Second Next Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Description
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.
Time Frame
From start of first next systemic therapy to start of second next systemic therapy (up to approximately 28 months)
Title
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants
Description
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.
Time Frame
From randomization to progression event (up to approximately 45 months)
Title
Progression-free Survival (PFS) on Next-line Therapy - All Randomized Participants With PD-L1 Expression Level < 1%
Description
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.
Time Frame
From randomization to progression event (up to approximately 45 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
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)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
The Angeles Clinic & Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Georgetown University Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Mount Sinai Comprehensive Cancer Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
UF Health Cancer Center at Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
19123
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Oncology Specialists, S.C.
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Mass General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University Of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5848
Country
United States
Facility Name
Virginia Piper Cancer Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School Of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Carolinas Med Ctr
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Providence Cancer Center Oncology And Hematology Care
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
St. Luke's University Health Network
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Local Institution
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Oncology Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Md Anderson Can Cnt
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University Of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Melanoma and Skin Cancer Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
55905
Country
United States
Facility Name
University Of Washington Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States
Facility Name
Local Institution
City
North Sydney
State/Province
New South Wales
ZIP/Postal Code
2060
Country
Australia
Facility Name
Local Institution
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Local Institution
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Local Institution
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Local Institution
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
ZIP/Postal Code
41950-610
Country
Brazil
Facility Name
Local Institution
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Local Institution
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Local Institution
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Local Institution
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14780-070
Country
Brazil
Facility Name
Local Institution
City
Sao Jose do Rio Preto
State/Province
SAO Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
ZIP/Postal Code
22793-080
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CHU de Quebec - Universite Laval
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Klinika komplexni onkologicke pece
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Klinika onkologie a radioterapie
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Dermatovenerologicka klinika 3. LF UK a FNKV
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
Dermatovenerologicka klinika VFN a 1. LF UK
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Centre Hospitalier Universitaire Dijon Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Hopital Claude Huriez
City
LILLE Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital De La Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Chu Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Local Institution
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Local Institution
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Laiko Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Metropolitan Hospital
City
Athens
ZIP/Postal Code
18547
Country
Greece
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
IRCCS Istituto Nazionale Tumori Milano
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto IOV
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Tauranga
State/Province
BAY OF Plenty
ZIP/Postal Code
3143
Country
New Zealand
Facility Name
Local Institution
City
Christchurch
Country
New Zealand
Facility Name
Local Institution
City
Dunedin
ZIP/Postal Code
9001
Country
New Zealand
Facility Name
Klinika Nowotworow Ukladowych i Uogolnionych
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Institute Of Oncology "Prof.Dr.Alexandru Trestioreanu" Bucha
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Sf. Nectarie Oncology Center
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Local Institution
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
Local Institution
City
Krasnoyarsk
ZIP/Postal Code
660133
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona-barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
H. Univ. Vall dHebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Regional Universitario De Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hosp Univ Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitario Y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Local Institution
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
The Beatson West Of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie Hospital Nhs Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital - Surrey
City
Sutton.
ZIP/Postal Code
SM25PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
36162037
Citation
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.
Results Reference
derived
PubMed Identifier
35512259
Citation
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
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
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