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A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma (RELATIVITY-098)

Primary Purpose

Melanoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nivolumab
Nivolumab + Relatlimab Fixed Dose Combination
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Relatlimab, Nivolumab, Opdivo

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
  • Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and 17 years of age must have a Lansky/Karnofsky performance score ≥ 80%
  • Complete resection must be performed within 90 days prior to randomization
  • All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
  • Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

  • History of ocular melanoma
  • Untreated/unresected CNS metastases or leptomeningeal metastases
  • Active, known, or suspected autoimmune disease
  • Participants with serious or uncontrolled medical disorder
  • Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
  • History of myocarditis, regardless of etiology. Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Local Institution - 0176
  • Local Institution - 0164
  • Local Institution - 0200
  • Local Institution - 0185
  • Local Institution - 0162
  • Local Institution - 0138
  • Local Institution - 0166
  • Local Institution - 0243
  • Local Institution
  • Local Institution - 0179
  • Local Institution - 0191
  • Local Institution - 0148
  • Local Institution - 0202
  • Local Institution - 0177
  • Local Institution - 0223
  • University of Iowa-Holden Comprehensive Cancer Center
  • Local Institution - 0178
  • Local Institution - 0258
  • Local Institution
  • Local Institution - 0133
  • Local Institution - 0139
  • Local Institution - 0206
  • Local Institution - 0140
  • Local Institution - 0210
  • Local Institution - 0130
  • Local Institution - 0145
  • Local Institution - 0141
  • Local Institution - 0267
  • Fox Chase Cancer Center
  • Local Institution - 0125
  • Local Institution - 0171
  • Local Institution - 0147
  • Local Institution - 0183
  • Local Institution - 0146
  • Local Institution - 0163
  • Local Institution - 0172
  • Local Institution - 0137
  • Clinica Adventista Belgrano-Oncology
  • Local Institution - 0005
  • Local Institution - 0002
  • Local Institution - 0003
  • Local Institution - 0004
  • Local Institution - 0030
  • Local Institution - 0252
  • Local Institution - 0032
  • Local Institution - 0028
  • Local Institution - 0027
  • Local Institution - 0250
  • Local Institution
  • Local Institution - 0035
  • Local Institution - 0253
  • Local Institution - 0031
  • Local Institution - 0251
  • Local Institution - 0029
  • Local Institution - 0082
  • Local Institution - 0086
  • Local Institution - 0084
  • Local Institution - 0110
  • Local Institution - 0105
  • Local Institution - 0109
  • Local Institution - 0106
  • Local Institution - 0071
  • Local Institution - 0072
  • Local Institution - 0068
  • Local Institution - 0047
  • Local Institution - 0056
  • Local Institution - 0257
  • Local Institution - 0049
  • Local Institution - 0048
  • Local Institution - 0070
  • Local Institution - 0058
  • Local Institution - 0155
  • Local Institution - 0175
  • Local Institution - 0197
  • Local Institution - 0158
  • Local Institution - 0159
  • Local Institution - 0160
  • Local Institution - 0198
  • Local Institution - 0013
  • Local Institution - 0006
  • Local Institution - 0014
  • Local Institution - 0259
  • Local Institution - 0261
  • Local Institution - 0214
  • Local Institution - 0241
  • Local Institution - 0245
  • Local Institution - 0217
  • Local Institution - 0226
  • Local Institution - 0237
  • Local Institution - 0239
  • Local Institution - 0234
  • Local Institution - 0215
  • Local Institution - 0224
  • Local Institution - 0219
  • Local Institution - 0242
  • Local Institution - 0230
  • Local Institution
  • Local Institution - 0228
  • Local Institution - 0222
  • Local Institution - 0216
  • Local Institution - 0244
  • Local Institution - 0156
  • Local Institution - 0091
  • Local Institution - 0026
  • Local Institution - 0062
  • Local Institution - 0022
  • Local Institution - 0018
  • Local Institution - 0020
  • Local Institution - 0007
  • Local Institution - 0019
  • Local Institution - 0015
  • Local Institution - 0040
  • Local Institution - 0043
  • Local Institution - 0044
  • Local Institution - 0039
  • Local Institution - 0042
  • Local Institution - 0041
  • Local Institution - 0046
  • Local Institution - 0092
  • Local Institution - 0079
  • Local Institution - 0073
  • Local Institution - 0077
  • Local Institution - 0074
  • Local Institution - 0131
  • Local Institution - 0081
  • Local Institution - 0075
  • Local Institution - 0078
  • Local Institution - 0083
  • Local Institution - 0076
  • Local Institution - 0080
  • Local Institution - 0114
  • Local Institution - 0113
  • Local Institution - 0112
  • Local Institution - 0118
  • Local Institution - 0116
  • Local Institution - 0199
  • Local Institution - 0117
  • Istituto Europeo di Oncologia IRCCS
  • Fondazione IRCCS Istituto Nazionale dei Tumori
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
  • Istituto Oncologico Veneto IRCCS-Oncologia del Melenoma
  • Azienda Ospedaliera Di Perugia
  • ospedale le scotte-U.O.C. Immunoterapia Oncologica
  • Local Institution - 0100
  • Local Institution - 0021
  • Local Institution - 0093
  • Local Institution - 0098
  • Local Institution - 0009
  • Local Institution - 0017
  • Local Institution - 0023
  • Local Institution - 0170
  • Local Institution - 0065
  • Local Institution - 0066
  • Local Institution - 0064
  • Local Institution - 0188
  • Local Institution - 0201
  • Local Institution - 0153
  • Local Institution - 0150
  • Local Institution - 0151
  • Local Institution - 0152
  • Local Institution - 0010
  • Local Institution - 0011
  • Local Institution - 0012
  • Local Institution - 0085
  • Local Institution - 0087
  • Local Institution - 0090
  • Local Institution - 0187
  • Local Institution - 0101
  • Local Institution - 0102
  • Local Institution - 0154
  • Local Institution - 0232
  • Local Institution - 0127

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm A: Nivolumab Plus Relatlimab

Arm B: Nivolumab

Arm Description

Combination

Monotherapy

Outcomes

Primary Outcome Measures

Recurrence-Free Survival (RFS) time per Investigator assessment

Secondary Outcome Measures

Overall Survival (OS)
Distant Metastasis-Free Survival (DMFS) time per Investigator assessment
Incidence of Adverse Events (AEs)
Severity of AEs
Incidence of Serious Adverse Events (SAEs)
Severity of SAEs
Incidence of AEs leading to discontinuation (DC)
Severity of AEs leading to DC
Incidence of immune-mediated AEs (IMAEs)
Severity of IMAEs
Incidence of drug related AEs
Severity of drug related AEs
Incidence of deaths
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Progression-Free Survival 2 (PFS2)

Full Information

First Posted
August 4, 2021
Last Updated
September 15, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05002569
Brief Title
A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma
Acronym
RELATIVITY-098
Official Title
A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
February 15, 2026 (Anticipated)
Study Completion Date
November 1, 2029 (Anticipated)

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 assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Relatlimab, Nivolumab, Opdivo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Nivolumab Plus Relatlimab
Arm Type
Experimental
Arm Description
Combination
Arm Title
Arm B: Nivolumab
Arm Type
Experimental
Arm Description
Monotherapy
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)
Nivolumab + Relatlimab Fixed Dose Combination
Other Intervention Name(s)
BMS-986213, Opdualag
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Recurrence-Free Survival (RFS) time per Investigator assessment
Time Frame
Approximately 52 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
Approximately 90 months
Title
Distant Metastasis-Free Survival (DMFS) time per Investigator assessment
Time Frame
Approximately 90 months
Title
Incidence of Adverse Events (AEs)
Time Frame
30 days from participant's last dose
Title
Severity of AEs
Time Frame
30 days from participant's last dose
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
30 days from participant's last dose
Title
Severity of SAEs
Time Frame
30 days from participant's last dose
Title
Incidence of AEs leading to discontinuation (DC)
Time Frame
30 days from participant's last dose
Title
Severity of AEs leading to DC
Time Frame
30 days from participant's last dose
Title
Incidence of immune-mediated AEs (IMAEs)
Time Frame
135 days from participant's last dose
Title
Severity of IMAEs
Time Frame
135 days from participant's last dose
Title
Incidence of drug related AEs
Time Frame
30 days from participant's last dose
Title
Severity of drug related AEs
Time Frame
30 days from participant's last dose
Title
Incidence of deaths
Time Frame
30 days from participant's last dose
Title
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time Frame
30 days from participant's last dose
Title
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Time Frame
30 days from participant's last dose
Title
Progression-Free Survival 2 (PFS2)
Time Frame
Approximately 52 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and < 18 years of age must have a Lansky/Karnofsky performance score ≥ 80% Complete resection must be performed within 90 days prior to randomization All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization Tumor tissue must be provided for biomarker analyses Exclusion Criteria: History of ocular melanoma Untreated/unresected CNS metastases or leptomeningeal metastases Active, known, or suspected autoimmune disease Participants with serious or uncontrolled medical disorder Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening History of myocarditis, regardless of etiology. Other protocol-defined inclusion/exclusion criteria 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
Local Institution - 0176
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Local Institution - 0164
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Local Institution - 0200
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Local Institution - 0185
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Local Institution - 0162
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Local Institution - 0138
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0166
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Local Institution - 0243
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Local Institution
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Local Institution - 0179
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Local Institution - 0191
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 0148
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Local Institution - 0202
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution - 0177
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Local Institution - 0223
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
University of Iowa-Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Local Institution - 0178
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Local Institution - 0258
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Local Institution
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Local Institution - 0133
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Local Institution - 0139
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 0206
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Local Institution - 0140
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0210
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Local Institution - 0130
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Local Institution - 0145
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0141
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution - 0267
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Local Institution - 0125
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Local Institution - 0171
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Local Institution - 0147
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Local Institution - 0183
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Local Institution - 0146
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Local Institution - 0163
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Local Institution - 0172
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0137
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Clinica Adventista Belgrano-Oncology
City
Caba
State/Province
Distrito Federal
ZIP/Postal Code
C1430
Country
Argentina
Facility Name
Local Institution - 0005
City
Ciudad Autónoma de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0002
City
Ciudad de Buenos Aires
State/Province
Distrito Federal
ZIP/Postal Code
C1121ABE
Country
Argentina
Facility Name
Local Institution - 0003
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Local Institution - 0004
City
Cordoba
ZIP/Postal Code
X5002HWE
Country
Argentina
Facility Name
Local Institution - 0030
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Local Institution - 0252
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 0032
City
Wollstonecraft
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution - 0028
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution - 0027
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Local Institution - 0250
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Local Institution
City
Ballarat Central
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Local Institution - 0035
City
Ballarat
State/Province
Victoria
ZIP/Postal Code
3350
Country
Australia
Facility Name
Local Institution - 0253
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 0031
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution - 0251
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Facility Name
Local Institution - 0029
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 0082
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution - 0086
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Local Institution - 0084
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution - 0110
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution - 0105
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution - 0109
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution - 0106
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Local Institution - 0071
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40170-070
Country
Brazil
Facility Name
Local Institution - 0072
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135237
Country
Brazil
Facility Name
Local Institution - 0068
City
Vitória
State/Province
Espirito Santo
ZIP/Postal Code
29055450
Country
Brazil
Facility Name
Local Institution - 0047
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30130-090
Country
Brazil
Facility Name
Local Institution - 0056
City
Ijui
State/Province
Rio Grande Do Sul
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0257
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Local Institution - 0049
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Local Institution - 0048
City
Santa Cruz do Sul
State/Province
RIO Grande DO SUL
ZIP/Postal Code
96830-180
Country
Brazil
Facility Name
Local Institution - 0070
City
Barretos
State/Province
SAO Paulo
ZIP/Postal Code
14784400
Country
Brazil
Facility Name
Local Institution - 0058
City
Rio de Janeiro
ZIP/Postal Code
20220-410
Country
Brazil
Facility Name
Local Institution - 0155
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6X 1E8
Country
Canada
Facility Name
Local Institution - 0175
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Local Institution - 0197
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Local Institution - 0158
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Local Institution - 0159
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 1P1
Country
Canada
Facility Name
Local Institution - 0160
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Local Institution - 0198
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Local Institution - 0013
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7510032
Country
Chile
Facility Name
Local Institution - 0006
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Local Institution - 0014
City
Santiago
State/Province
Metropolitana
Country
Chile
Facility Name
Local Institution - 0259
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Local Institution - 0261
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100035
Country
China
Facility Name
Local Institution - 0214
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Local Institution - 0241
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Local Institution - 0245
City
Fuzhou City
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Local Institution - 0217
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Local Institution - 0226
City
Zhengzhou Shi
State/Province
Henan
ZIP/Postal Code
450001
Country
China
Facility Name
Local Institution - 0237
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Local Institution - 0239
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Local Institution - 0234
City
Changsha Shi
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Local Institution - 0215
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
Local Institution - 0224
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Local Institution - 0219
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Local Institution - 0242
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Facility Name
Local Institution - 0230
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Local Institution
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Local Institution - 0228
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Facility Name
Local Institution - 0222
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650106
Country
China
Facility Name
Local Institution - 0216
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Local Institution - 0244
City
Taiyuan
ZIP/Postal Code
030032
Country
China
Facility Name
Local Institution - 0156
City
Brno
ZIP/Postal Code
65653
Country
Czechia
Facility Name
Local Institution - 0091
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Local Institution - 0026
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Local Institution - 0062
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Local Institution - 0022
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Local Institution - 0018
City
Copenhagen
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Local Institution - 0020
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution - 0007
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Local Institution - 0019
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Local Institution - 0015
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Local Institution - 0040
City
Villejuif
State/Province
Val-de-Marne
ZIP/Postal Code
94800
Country
France
Facility Name
Local Institution - 0043
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Local Institution - 0044
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution - 0039
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution - 0042
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution - 0041
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Local Institution - 0046
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Local Institution - 0092
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 0079
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution - 0073
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Local Institution - 0077
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Local Institution - 0074
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution - 0131
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Local Institution - 0081
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Local Institution - 0075
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Local Institution - 0078
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Local Institution - 0083
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Local Institution - 0076
City
Munich
ZIP/Postal Code
80337
Country
Germany
Facility Name
Local Institution - 0080
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution - 0114
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution - 0113
City
Neo Faliro
ZIP/Postal Code
185 47
Country
Greece
Facility Name
Local Institution - 0112
City
Thessaloniki
ZIP/Postal Code
540 07
Country
Greece
Facility Name
Local Institution - 0118
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Local Institution - 0116
City
Afula
ZIP/Postal Code
1834111
Country
Israel
Facility Name
Local Institution - 0199
City
Ramag Gan
ZIP/Postal Code
526200
Country
Israel
Facility Name
Local Institution - 0117
City
Ramat Gan
ZIP/Postal Code
5262100
Country
Israel
Facility Name
Istituto Europeo di Oncologia IRCCS
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale-s.c. melanoma, immunoterapia oncologica e terapie
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Oncologico Veneto IRCCS-Oncologia del Melenoma
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliera Di Perugia
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
ospedale le scotte-U.O.C. Immunoterapia Oncologica
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution - 0100
City
Benito Juarez
State/Province
Distrito Federal
ZIP/Postal Code
03240
Country
Mexico
Facility Name
Local Institution - 0021
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Local Institution - 0093
City
Mexico
State/Province
Nuevo LEON
ZIP/Postal Code
64320
Country
Mexico
Facility Name
Local Institution - 0098
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Facility Name
Local Institution - 0009
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
Facility Name
Local Institution - 0017
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Local Institution - 0023
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
Local Institution - 0170
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Local Institution - 0065
City
Cluj
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0066
City
Craiova
ZIP/Postal Code
200542
Country
Romania
Facility Name
Local Institution - 0064
City
Floresti/ Cluj
ZIP/Postal Code
407280
Country
Romania
Facility Name
Local Institution - 0188
City
Badajoz
ZIP/Postal Code
06071
Country
Spain
Facility Name
Local Institution - 0201
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0153
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Local Institution - 0150
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Local Institution - 0151
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Local Institution - 0152
City
València
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution - 0010
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
Local Institution - 0011
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Local Institution - 0012
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
Local Institution - 0085
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution - 0087
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
Local Institution - 0090
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution - 0187
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Local Institution - 0101
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Local Institution - 0102
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Local Institution - 0154
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Local Institution - 0232
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Local Institution - 0127
City
Southampton
ZIP/Postal Code
SO16 0YD
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting
URL
http://www.fda.gov/safety/medwatch/safetyinformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

Learn more about this trial

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

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