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A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Primary Purpose

Cancer, Melanoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-986253
Nivolumab
Ipilimumab
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
  • At least 1 lesion accessible for biopsy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1

Exclusion Criteria:

  • Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
  • Participants with active, known or suspected autoimmune disease
  • Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
  • Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
  • Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • Local Institution - 0059
  • Local Institution - 0099
  • Local Institution - 0007
  • Local Institution
  • Local Institution - 0087
  • Local Institution - 0100
  • Local Institution - 0101
  • Local Institution - 0012
  • Local Institution - 0003
  • Local Institution - 0060
  • University Of Michigan Health System
  • Local Institution - 0076
  • Comprehensive Cancer Centers Of Nevada
  • Local Institution - 0005
  • Atlantic Health System Morristown Medical Center
  • Rutgers Cancer Institute of New Jersey
  • Local Institution - 0025
  • Local Institution - 0002
  • Local Institution - 0028
  • Local Institution - 0017
  • Local Institution
  • Local Institution - 0001
  • Local Institution - 0009
  • Local Institution - 0011
  • Local Institution - 0010
  • Texas Oncology-Fort Worth 12th Ave
  • Local Institution - 0018
  • Local Institution - 0006
  • Local Institution - 0013
  • Local Institution - 0058
  • Local Institution - 0015
  • Local Institution - 0008
  • Local Institution - 0117
  • Local Institution - 0118
  • Local Institution - 0119
  • Local Institution - 0088Recruiting
  • Local Institution - 0096Recruiting
  • Local Institution - 0090Recruiting
  • Local Institution - 0095Recruiting
  • Local Institution - 0097Recruiting
  • Local Institution - 0091Recruiting
  • Local Institution - 0037Recruiting
  • Local Institution - 0036Recruiting
  • Local Institution - 0082Recruiting
  • Local Institution - 0030Recruiting
  • Local Institution - 0029Recruiting
  • Local Institution - 0078Recruiting
  • Local Institution - 0020
  • Local Institution - 0055Recruiting
  • Local Institution - 0056Recruiting
  • Local Institution - 0114
  • Local Institution - 0113
  • Local Institution - 0115
  • Assistance Publique Hôpitaux de Marseille - Hôpital de la TimoneRecruiting
  • Hotel Dieu - Chu De NantesRecruiting
  • Hopital Saint LouisRecruiting
  • Institut Claudius RegaudRecruiting
  • Gustave Roussy-Medicine department - DermatologyRecruiting
  • Local Institution - 0054Recruiting
  • Local Institution - 0052Recruiting
  • Local Institution - 0034Recruiting
  • Local Institution
  • Local Institution
  • Local Institution - 0053Recruiting
  • Local Institution
  • IRST MeldolaRecruiting
  • Ospedale San RaffaeleRecruiting
  • Istituto Nazionale Tumori Fondazione PascaleRecruiting
  • Irccs Istituto Clinico HumanitasRecruiting
  • Local Institution - 0071Recruiting
  • Local Institution - 0077Recruiting
  • Local Institution - 0111
  • Local Institution - 0112
  • Local Institution - 0045
  • Local Institution - 0022Recruiting
  • Local Institution - 0023Recruiting
  • Local Institution - 0044Recruiting
  • Local Institution - 0021Recruiting
  • Local Institution - 0047Recruiting
  • Local Institution - 0040Recruiting
  • Local Institution - 0041Recruiting
  • Local Institution - 0039Recruiting
  • Local Institution - 0024Recruiting
  • Local Institution - 0083Recruiting
  • Local Institution - 0019Recruiting
  • Local Institution - 0105

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Part 1A: BMS-986253 + nivolumab

Part 1B: BMS-986253 + nivolumab

Part 1C: BMS-986253 + nivolumab + ipilimumab

Part 2A: BMS-986253 + nivolumab + ipilimumab

Part 2B: Placebo + nivolumab + ipilimumab

Arm Description

Outcomes

Primary Outcome Measures

Incidence of adverse events (AE)
Part 1
Incidence of serious adverse events (SAE)
Part 1
Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria
Part 1
Incidence of AEs leading to discontinuation
Part 1
Incidence of deaths
Part 1
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Part 1
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Part 1
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Part 1
Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Part 2, participants with advanced melanoma, selected by baseline serum interleukin-8 (IL-8) level using RECIST v1.1

Secondary Outcome Measures

Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Part 1 and Part 2
Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1
Part 1
Incidence of anti-drug antibody (ADA) to BMS-986253
Part 1 and Part 2
Serum biomarker concentration
Part 1
Maximum observed serum concentration (Cmax)
Part 1 and Part 2
Time of maximum observed serum concentration (Tmax)
Part 1 and Part 2
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Part 1 and Part 2
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Part 1 and Part 2
Observed serum concentration at the end of a dosing interval (CTAU)
Part 1 and Part 2
Trough observed serum concentration at the end of the dosing interval (CTROUGH)
Part 1 and Part 2
Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels)
Overall Survival (OS)
Part 2
Incidence of AEs
Part 2
Incidence of SAEs
Part 2
Incidence of AEs leading to discontinuation
Part 2
Incidence of death
Part 2
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Part 2
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Part 2
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Part 2

Full Information

First Posted
January 12, 2018
Last Updated
October 16, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03400332
Brief Title
A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Official Title
A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
November 30, 2025 (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 investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part 1A: BMS-986253 + nivolumab
Arm Type
Experimental
Arm Title
Part 1B: BMS-986253 + nivolumab
Arm Type
Experimental
Arm Title
Part 1C: BMS-986253 + nivolumab + ipilimumab
Arm Type
Experimental
Arm Title
Part 2A: BMS-986253 + nivolumab + ipilimumab
Arm Type
Experimental
Arm Title
Part 2B: Placebo + nivolumab + ipilimumab
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-986253
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558, Opdivo
Intervention Description
Specified dose on specified days
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, YERVOY
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Incidence of adverse events (AE)
Description
Part 1
Time Frame
Approximately 5 years
Title
Incidence of serious adverse events (SAE)
Description
Part 1
Time Frame
Approximately 5 years
Title
Incidence of AEs meeting protocol-defined dose limiting toxicities (DLT) criteria
Description
Part 1
Time Frame
Approximately 5 years
Title
Incidence of AEs leading to discontinuation
Description
Part 1
Time Frame
Approximately 5 years
Title
Incidence of deaths
Description
Part 1
Time Frame
Approximately 5 years
Title
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Description
Part 1
Time Frame
Approximately 5 years
Title
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Description
Part 1
Time Frame
Approximately 5 years
Title
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Description
Part 1
Time Frame
Approximately 5 years
Title
Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Description
Part 2, participants with advanced melanoma, selected by baseline serum interleukin-8 (IL-8) level using RECIST v1.1
Time Frame
Approximately 5 years
Secondary Outcome Measure Information:
Title
Objective response rate (ORR) based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Description
Part 1 and Part 2
Time Frame
Approximately 5 years
Title
Median duration of response (mDOR) per response evaluation criteria in solid tumors (RECIST) v1.1
Description
Part 1
Time Frame
Approximately 5 years
Title
Incidence of anti-drug antibody (ADA) to BMS-986253
Description
Part 1 and Part 2
Time Frame
Approximately 5 years
Title
Serum biomarker concentration
Description
Part 1
Time Frame
Approximately 5 years
Title
Maximum observed serum concentration (Cmax)
Description
Part 1 and Part 2
Time Frame
Approximately 5 years
Title
Time of maximum observed serum concentration (Tmax)
Description
Part 1 and Part 2
Time Frame
Approximately 5 years
Title
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Description
Part 1 and Part 2
Time Frame
Approximately 5 years
Title
Area under the serum concentration-time curve in 1 dosing interval [AUC(TAU)]
Description
Part 1 and Part 2
Time Frame
Approximately 5 years
Title
Observed serum concentration at the end of a dosing interval (CTAU)
Description
Part 1 and Part 2
Time Frame
Approximately 5 years
Title
Trough observed serum concentration at the end of the dosing interval (CTROUGH)
Description
Part 1 and Part 2
Time Frame
Approximately 5 years
Title
Progression-free survival (PFS) hazard ratio based on Blinded independent central review (BICR) assessments per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Description
Part 2, participants with advanced melanoma, using RECIST v1.1 (regardless of baseline serum IL-8 levels)
Time Frame
Approximately 5 years
Title
Overall Survival (OS)
Description
Part 2
Time Frame
Approximately 5 years
Title
Incidence of AEs
Description
Part 2
Time Frame
Approximately 5 years
Title
Incidence of SAEs
Description
Part 2
Time Frame
Approximately 5 years
Title
Incidence of AEs leading to discontinuation
Description
Part 2
Time Frame
Approximately 5 years
Title
Incidence of death
Description
Part 2
Time Frame
Approximately 5 years
Title
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Description
Part 2
Time Frame
Approximately 5 years
Title
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Description
Part 2
Time Frame
Approximately 5 years
Title
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Description
Part 2
Time Frame
Approximately 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1 At least 1 lesion accessible for biopsy Eastern Cooperative Oncology Group Performance Status of 0 or 1 Exclusion Criteria: Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll) Participants with active, known or suspected autoimmune disease Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS) Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy Other protocol defined inclusion/exclusion criteria could apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
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 - 0059
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0099
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0007
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0087
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0100
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0101
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0012
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0003
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0060
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University Of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0076
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Comprehensive Cancer Centers Of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0005
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Atlantic Health System Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Whitman, Site 0107
Phone
973-971-7111
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0025
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0002
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0028
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0017
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0001
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0009
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0011
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0010
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Completed
Facility Name
Texas Oncology-Fort Worth 12th Ave
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104-3927
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0018
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0006
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0013
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0058
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Local Institution - 0015
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0008
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Completed
Facility Name
Local Institution - 0117
City
Buenos Aires
ZIP/Postal Code
C1187AAN
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0117
Facility Name
Local Institution - 0118
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0118
Facility Name
Local Institution - 0119
City
Wagga Wagga
State/Province
New South Wales
ZIP/Postal Code
2650
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0119
Facility Name
Local Institution - 0088
City
Wollstonecraft
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0088
Facility Name
Local Institution - 0096
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0096
Facility Name
Local Institution - 0090
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0090
Facility Name
Local Institution - 0095
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0095
Facility Name
Local Institution - 0097
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0097
Facility Name
Local Institution - 0091
City
Ballarat Central
ZIP/Postal Code
VIC 3350
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0091
Facility Name
Local Institution - 0037
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Local Institution - 0036
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0082
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0082
Facility Name
Local Institution - 0030
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0030
Facility Name
Local Institution - 0029
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0078
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0078
Facility Name
Local Institution - 0020
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Individual Site Status
Completed
Facility Name
Local Institution - 0055
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0055
Facility Name
Local Institution - 0056
City
Montréal
ZIP/Postal Code
H2X 0A9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0056
Facility Name
Local Institution - 0114
City
Santiago
State/Province
Región Metropolitana De Santiago
ZIP/Postal Code
7500921
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0114
Facility Name
Local Institution - 0113
City
Santiago
State/Province
Región Metropolitana De Santiago
ZIP/Postal Code
8330032
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0113
Facility Name
Local Institution - 0115
City
Santiago
State/Province
Región Metropolitana De Santiago
ZIP/Postal Code
8420383
Country
Chile
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0115
Facility Name
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
City
Marseille
State/Province
Bouches-du-Rhône
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Gaudy, Site 0067
Phone
33491387991
Facility Name
Hotel Dieu - Chu De Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaelle Quereux, Site 0085
Phone
02 40 08 31 44
Facility Name
Hopital Saint Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celeste Lebbe, Site 0068
Phone
33142494949
Facility Name
Institut Claudius Regaud
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecile Pages Laurent, Site 0102
Phone
33531155675
Facility Name
Gustave Roussy-Medicine department - Dermatology
City
Villejuif
ZIP/Postal Code
94800
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Robert, Site 0069
Phone
33142114210
Facility Name
Local Institution - 0054
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0054
Facility Name
Local Institution - 0052
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0034
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution
City
Gerlingen
ZIP/Postal Code
70839
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0053
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Withdrawn
Facility Name
IRST Meldola
City
Forlì
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Delmonte, Site 0043
Phone
+393487469100
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gianluca Del Conte, Site 0042
Phone
+390226436523
Facility Name
Istituto Nazionale Tumori Fondazione Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Ascierto, Site 0027
Phone
390815903431
Facility Name
Irccs Istituto Clinico Humanitas
City
Rozzano-milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Simonelli, Site 0026
Phone
+390282244559
Facility Name
Local Institution - 0071
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0071
Facility Name
Local Institution - 0077
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0077
Facility Name
Local Institution - 0111
City
Barcelona
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0111
Facility Name
Local Institution - 0112
City
Barcelona
State/Province
Catalunya [Cataluña]
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0112
Facility Name
Local Institution - 0045
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Completed
Facility Name
Local Institution - 0022
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0023
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0044
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0044
Facility Name
Local Institution - 0021
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0047
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0047
Facility Name
Local Institution - 0040
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0041
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0041
Facility Name
Local Institution - 0039
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0024
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0024
Facility Name
Local Institution - 0083
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0083
Facility Name
Local Institution - 0019
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0019
Facility Name
Local Institution - 0105
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0105

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

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