Back to resultsA Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
Primary Purpose
Unresectable or Metastatic Melanoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BMS-936558
Dacarbazine
Carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable or Metastatic Melanoma
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Men & women ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- Histologically confirmed Stage III (unresectable)/Stage IV melanoma
- Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
- Pre-treatment fresh core, excision or punch tumor biopsy
- Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
Exclusion Criteria:
- Any treatment in a BMS-936558 (Nivolumab) trial
- Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
- Active, known or suspected autoimmune disease
- Unknown BRAF status
- Active brain metastasis or leptomeningeal metastasis
- Ocular melanoma
- Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)
Sites / Locations
- Mayo Clinic
- UCSD Moores Cancer Center
- The Angeles Clinic & Research Institute
- University Of California - Los Angeles
- San Francisco Oncology Associates
- UCSF Comprehensive Cancer Center
- University Of Colorado
- Yale University School Of Medicine
- Mount Sinai Comprehensive Cancer Center
- Orlando Health, Inc
- H. Lee Moffitt Cancer Center & Research Institute
- Winship Cancer Institute
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
- Dana-Farber Cancer Institute
- University Of Michigan Health System
- Karmanos Cancer Institute
- Allina Health
- Washington University School Of Medicine
- Roswell Park Cancer Institute
- NYU Clinical Cancer Center
- MSKCC Clinical Laboratory at Nassau
- Levine Cancer Institute
- Duke University Medical Center
- University Hospitals
- Providence Oncology And Hematology
- Network Office of Research and Innovation
- St. Luke'S Health System
- Hillman Cancer Center
- Tennessee Oncology, PLLC
- Vanderbilt-Ingram Cancer Center
- Huntsman Cancer Institute
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Cross Cancer Institute
- Princess Margaret Hospital
- CHUM
- Sir Mortimer B Davis - Jewish General Hospital
- Aarhus Universitetshospital
- Herlev Hospital
- Odense University Hospital
- Local Institution
- Local Institution
- Hopital La Timone
- 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
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BMS-936558 3 mg/kg (IV)
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Arm Description
BMS-936558 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
Overall Survival (OS)
Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.
Secondary Outcome Measures
Progression Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.
Objective Response Rate (ORR) by Baseline PD-L1 Expression
Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.
Overall Survival (OS) by PD-L1 Positive
Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Overall Survival (OS) by PD-L1 Negative
Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.
Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.
A 10 point difference on a 100 point scale between treatments was considered clinically significant.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01721746
Brief Title
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
Official Title
A Randomized Open-Label Phase 3 Trial of BMS-936558 (Nivolumab) Versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
December 21, 2012 (Actual)
Primary Completion Date
February 16, 2016 (Actual)
Study Completion Date
December 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to estimate the response rate and compare overall survival of patients taking BMS-936558 to those taking study physician's choice of either Dacarbazine or Carboplatin and Paclitaxel
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable or Metastatic Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-936558 3 mg/kg (IV)
Arm Type
Experimental
Arm Description
BMS-936558 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Arm Title
Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)
Arm Type
Active Comparator
Arm Description
Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
Intervention Type
Biological
Intervention Name(s)
BMS-936558
Intervention Type
Drug
Intervention Name(s)
Dacarbazine
Other Intervention Name(s)
DTIC-Dome, DTIC
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin, CBDCA
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Onxol
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Objective response rate (ORR) per Independent Review Committee (IRC) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of randomized participants using RECIST 1.1
Time Frame
From date of randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (Up to approximately 38 months)
Title
Overall Survival (OS)
Description
Overall Survival (OS) was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive. Unit of measure (months) is the median survival time.
Time Frame
Up to 96 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented progression, as determined by the Independent Review Committee (IRC) using RECIST 1.1, or death due to any cause, whichever occurs first. Participants who died without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment before subsequent anti-cancer therapy. Unit of measure (months) is the median survival time.
Time Frame
From the date of randomization to the date of the first documented progression or death (Up to approximately 38 months)
Title
Objective Response Rate (ORR) by Baseline PD-L1 Expression
Description
Objective Response Rate (ORR) is defined as the number of participants with a Best Overall Response (BOR) of complete response (CR) or partial response (PR) divided by number of randomized participants. PD-L1 expression evaluated for ORR.
Time Frame
From date of randomization to the date of objectively documented progression or the date of subsequent therapy (Up to approximately 38 months)
Title
Overall Survival (OS) by PD-L1 Positive
Description
Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Time Frame
Up to 96 months
Title
Overall Survival (OS) by PD-L1 Negative
Description
Overall Survival (OS) by PD-L1 expression was defined the time between the date of randomization to the date of death. For participants without documentation of death, OS was censored on the last date the participant was known to be alive.
Time Frame
Up to 96 months
Title
Mean Change From Baseline in Health-related Quality of Life (HRQoL)
Description
Health-related Quality of Life (HRQoL) was assessed with the EORTC QLQ-C30 questionnaire, which is the most commonly used quality-of-life instrument in oncology trials. The instrument's 30 items were divided among 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global health/quality of life scale. Raw scores for the EORTC QLQ-C30 were transformed to a 0-100 metric.
Higher scores for all functional scales and Global Health Status=better HRQoL Increase from baseline indicates improvement in HRQoL. Lower scores for symptom scales=better HRQoL Decline from baseline for symptom scales =improvement in symptoms compared to baseline.
A 10 point difference on a 100 point scale between treatments was considered clinically significant.
Time Frame
From Baseline (Day1) to second Follow-Up (Up to 96 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Men & women ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
Histologically confirmed Stage III (unresectable)/Stage IV melanoma
Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Objective evidence of disease progression (clinical or radiological) during or after at least 1 (V600 Wildtype) or at least 2 (V600 mutation positive) prior treatment regimens
Pre-treatment fresh core, excision or punch tumor biopsy
Archival Formalin-fixed paraffin-embedded (FFPE) tumor material if available
Exclusion Criteria:
Any treatment in a BMS-936558 (Nivolumab) trial
Subjects with condition requiring systemic treatment with either corticosteroids (> 10mg daily prednisone/equivalent) or other immunosuppressive medications within 14 days of study drug administration
Active, known or suspected autoimmune disease
Unknown BRAF status
Active brain metastasis or leptomeningeal metastasis
Ocular melanoma
Prior therapy with anti programmed death-1 (anti-PD-1), anti programmed death-ligand 1 (anti-PD-L1) or anti-programmed death-ligand 2 (anti-PD-L2)
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
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
UCSD Moores Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
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
University Of California - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
San Francisco Oncology Associates
City
San Francciso
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
UCSF Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University Of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
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
Orlando Health, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
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
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
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
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Allina Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
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
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
NYU Clinical Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
MSKCC Clinical Laboratory at Nassau
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
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
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Providence Oncology And Hematology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Network Office of Research and Innovation
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
St. Luke'S Health System
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18109
Country
United States
Facility Name
Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Local Institution
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
A-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
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Local Institution
City
Rio de Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
Sir Mortimer B Davis - Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital La Timone
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
Local Institution
City
Nantes Cedex 01
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Local Institution
City
Frankfurt am Main
ZIP/Postal Code
60590
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
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Local Institution
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Local Institution
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Local Institution
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1066 CX
Country
Netherlands
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Local Institution
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28020
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Pamplona
ZIP/Postal Code
31192
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46014
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
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Local Institution
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle Upon Tyne
State/Province
Tyne And Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28671856
Citation
Larkin J, Minor D, D'Angelo S, Neyns B, Smylie M, Miller WH Jr, Gutzmer R, Linette G, Chmielowski B, Lao CD, Lorigan P, Grossmann K, Hassel JC, Sznol M, Daud A, Sosman J, Khushalani N, Schadendorf D, Hoeller C, Walker D, Kong G, Horak C, Weber J. Overall Survival in Patients With Advanced Melanoma Who Received Nivolumab Versus Investigator's Choice Chemotherapy in CheckMate 037: A Randomized, Controlled, Open-Label Phase III Trial. J Clin Oncol. 2018 Feb 1;36(4):383-390. doi: 10.1200/JCO.2016.71.8023. Epub 2017 Jul 3.
Results Reference
derived
PubMed Identifier
25795410
Citation
Weber JS, D'Angelo SP, Minor D, Hodi FS, Gutzmer R, Neyns B, Hoeller C, Khushalani NI, Miller WH Jr, Lao CD, Linette GP, Thomas L, Lorigan P, Grossmann KF, Hassel JC, Maio M, Sznol M, Ascierto PA, Mohr P, Chmielowski B, Bryce A, Svane IM, Grob JJ, Krackhardt AM, Horak C, Lambert A, Yang AS, Larkin J. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):375-84. doi: 10.1016/S1470-2045(15)70076-8. Epub 2015 Mar 18.
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.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Study to Compare BMS-936558 to the Physician's Choice of Either Dacarbazine or Carboplatin and Paclitaxel in Advanced Melanoma Patients That Have Progressed Following Anti-CTLA-4 Therapy (CheckMate 037)
We'll reach out to this number within 24 hrs