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An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Nivolumab in combination with Ipilimumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically confirmed Stage 4 or recurrent non-small cell lung cancer
  • Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer)
  • No prior systemic anticancer therapy (including EGFR and ALK inhibitors)
  • Tissue or Programmed death-ligand 1 (PD-L1) results available

Cohort 1A Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) score 2 or
  • Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol

Cohort C Inclusion Criteria:

  • High Tumor Mutation Burden

Exclusion Criteria:

  • Untreated brain metastases
  • An active malignancy that requires concurrent intervention
  • Active, known or suspected autoimmune disease
  • Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer

Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Local Institution - 0121
  • Local Institution - 0148
  • Local Institution - 0085
  • Local Institution - 0164
  • Local Institution - 0146
  • Marin Cancer Care, Inc
  • Los Angeles Hematology/Oncology Medical Group
  • Local Institution - 0115
  • Torrance Health Association
  • Va San Diego Healthcare System
  • Local Institution - 0143
  • Local Institution - 0144
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
  • Local Institution - 0161
  • Local Institution - 0083
  • Local Institution - 0141
  • Cancer Specialists of North FL
  • Local Institution - 0082
  • Local Institution - 0147
  • Local Institution - 0163
  • Local Institution - 0002
  • Local Institution - 0166
  • Local Institution - 0088
  • Local Institution - 0108
  • Kentucky One Health St. Joseph East Cancer Center
  • Local Institution - 0091
  • Local Institution - 0089
  • Jackson Oncology Associates, Pllc
  • Local Institution - 0077
  • Local Institution - 0087
  • Local Institution - 0170
  • Local Institution - 0156
  • Summit Medical Group
  • Local Institution - 0142
  • Local Institution - 0167
  • Local Institution - 0004
  • Local Institution - 0012
  • Local Institution - 0100
  • Local Institution - 0134
  • Local Institution - 0172
  • Local Institution - 0096
  • Local Institution - 0176
  • Local Institution - 0139
  • Allegheny Health Network
  • Local Institution - 0159
  • Local Institution - 0001
  • Local Institution - 0123
  • Local Institution - 0066
  • Local Institution - 0067
  • Local Institution - 0090
  • Texas Oncology, P.A.
  • Local Institution - 0149
  • Local Institution - 0094
  • Local Institution - 0093
  • Local Institution - 0098
  • Local Institution - 0086
  • Local Institution - 0097
  • Local Institution - 0044
  • Providence Regional Cancer Partnership
  • Local Institution - 0174
  • Local Institution - 0173
  • Local Institution - 0008
  • Local Institution - 0006
  • Local Institution - 0007
  • Local Institution - 0009
  • Local Institution - 0126
  • Local Institution - 0038
  • Local Institution - 0037
  • Local Institution - 0036
  • Local Institution - 0152
  • Local Institution - 0154
  • Local Institution - 0153
  • Local Institution - 0151
  • Local Institution - 0127
  • Local Institution - 0109
  • Local Institution - 0049
  • Local Institution - 0050
  • Local Institution - 0010
  • Local Institution - 0011
  • Local Institution - 0133
  • Local Institution - 0130
  • Local Institution - 0118
  • Local Institution - 0075
  • Local Institution - 0069
  • Local Institution - 0076
  • Local Institution - 0074
  • Local Institution - 0071
  • Local Institution - 0070
  • Local Institution - 0072
  • Local Institution - 0073
  • Local Institution - 0023
  • Local Institution - 0028
  • Local Institution - 0029
  • Local Institution - 0026
  • Local Institution - 0025
  • Local Institution - 0030
  • Local Institution - 0031
  • Local Institution - 0032
  • Local Institution - 0013
  • Local Institution - 0014
  • Local Institution - 0054
  • Ospedale Policlinico San Martino
  • IRST Meldola
  • AOU della Campania Luigi Vanvitelli
  • Local Institution
  • Ospedale Degli Infermi
  • Azienda Ospedaliera Universitaria Senese
  • Azienda Ospedaliera Santa Maria Terni
  • Local Institution - 0019
  • Local Institution - 0045
  • Local Institution - 0035
  • Local Institution - 0015
  • Local Institution - 0068
  • Local Institution - 0016
  • Local Institution - 0128
  • Local Institution - 0119
  • Local Institution - 0120
  • Local Institution - 0022
  • Local Institution - 0021
  • Local Institution - 0020
  • Local Institution - 0061
  • Local Institution - 0060
  • Local Institution - 0062
  • Local Institution - 0065
  • Local Institution - 0064
  • Local Institution - 0063
  • Local Institution - 0059
  • Local Institution - 0112
  • Local Institution - 0048
  • Local Institution - 0046
  • Local Institution - 0104
  • Local Institution - 0041
  • Local Institution - 0039
  • Local Institution - 0040
  • Local Institution - 0043
  • Local Institution - 0042

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nivolumab in combination with Ipilimumab

Arm Description

Specified dose on specified days

Outcomes

Primary Outcome Measures

Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)
Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)
imAEs are specific events that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis). AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death

Secondary Outcome Measures

Progression Free Survival (PFS)
PFS is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
Overall Survival (OS)
OS is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Duration of Response (DoR)
DoR is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression per RECIST 1.1, or death due to any cause, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L)
FACT-L is a quality-of-life questionnaire which includes Lung Cancer Subscale (LCS) that assesses the treatment impact on lung cancer related symptoms in 5 domains: Physical, social/family, emotional, and functional well-being using a 5-point scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) added to obtain total score. The ranges of possible total scores are 0-136 for the FACT-L with a higher score representing better quality of life, improved symptomatology and enhanced physical/functional outcomes. According to Functional Assessment of Chronic Illness Therapy scoring guidelines, in the event of missing responses for some of the questions, scores will be prorated using the average of the other answers in that scale. Baseline is defined as events that occur before the date/time of first dose. Post treatment visits include follow-up (FU) visit 1, FU visit 2, and subsequent survival FU visits to occur every 3 months up until survival FU visit 18.

Full Information

First Posted
August 12, 2016
Last Updated
June 12, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT02869789
Brief Title
An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers
Official Title
A Phase 3b/4 Safety Trial of Flat Dose Nivolumab In Combination With Ipilimumab in Participants With Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2016 (Actual)
Primary Completion Date
May 13, 2022 (Actual)
Study Completion Date
May 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A study to evaluate the safety of Nivolumab given in combination with Ipilimumab in patients with advanced cancers. The initial group will enroll patients with newly diagnosed Stage 4 or non-small cell lung cancer that has come back.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1041 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nivolumab in combination with Ipilimumab
Arm Type
Experimental
Arm Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Nivolumab in combination with Ipilimumab
Other Intervention Name(s)
BMS-936558 (Nivolumab), Opdivo (Nivolumab), BMS-734016 (Ipilimumab), Yervoy (Ipilimumab)
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Number of Participants With High Grade (Grade 3-4 and Grade 5) Drug-Related Select Adverse Events (AEs)
Description
Drug related AEs are those events with relationship to study drug. If the relationship to study drug is missing, the AE will be considered as drug-related. The select AEs of interest are the following: Pulmonary, Renal, Gastrointestinal, Hepatic, Skin, Endocrine, and hypersensitivity/infusion reaction events. AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
Time Frame
From first dose to 30 days post last dose (Up to approximately 27 months)
Title
Number of Participants With High Grade (Grade 3-4 and Grade 5) Immune-Mediated Adverse Events (imAEs)
Description
imAEs are specific events that include pneumonitis, diarrhea/colitis, hepatitis, nephritis/renal dysfunction, rash, and endocrine (adrenal insufficiency, hypothyroidism/thyroiditis, hyperthyroidism, diabetes mellitus, and hypophysitis). AEs are reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade 3= Prolonged severe reaction Grade 4= Life threatening Grade 5= Death
Time Frame
From first dose to 100 days post last dose (Up to approximately 29 months)
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST v1.1), or death due to any cause, whichever occurs first. Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame
From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)
Title
Overall Survival (OS)
Description
OS is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive.
Time Frame
From first dosing date to the date of death (Up to approximately 67 months)
Title
Objective Response Rate (ORR)
Description
ORR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR). CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame
From first dosing date up to approximately 67 months
Title
Duration of Response (DoR)
Description
DoR is defined as the time between the date of first confirmed complete response (CR) or partial response (PR) to the date of the first documented tumor progression per RECIST 1.1, or death due to any cause, whichever occurs first. CR= Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD)= ≥ 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of ≥ 5 mm. The appearance of one or more new lesions is also considered progression.
Time Frame
From first dosing date to the date of first documented tumor progression or, death due to any cause, whichever occurs first (Up to approximately 67 months)
Title
Change From Baseline in Health-Related Quality of Life (HRQoL) Using Functional Assessment of Cancer Therapy-Lung (FACT-L)
Description
FACT-L is a quality-of-life questionnaire which includes Lung Cancer Subscale (LCS) that assesses the treatment impact on lung cancer related symptoms in 5 domains: Physical, social/family, emotional, and functional well-being using a 5-point scale (0=not at all; 1=a little bit, 2=somewhat; 3=quite a bit; 4=very much) added to obtain total score. The ranges of possible total scores are 0-136 for the FACT-L with a higher score representing better quality of life, improved symptomatology and enhanced physical/functional outcomes. According to Functional Assessment of Chronic Illness Therapy scoring guidelines, in the event of missing responses for some of the questions, scores will be prorated using the average of the other answers in that scale. Baseline is defined as events that occur before the date/time of first dose. Post treatment visits include follow-up (FU) visit 1, FU visit 2, and subsequent survival FU visits to occur every 3 months up until survival FU visit 18.
Time Frame
From baseline and up to subsequent survival follow-up visit 18 (Up to approximately 67 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed Stage 4 or recurrent non-small cell lung cancer Eastern Cooperative Oncology Group (ECOG) score 0-1 (Physically able to carry out light housework or office work through to being fully active as you were before cancer) No prior systemic anticancer therapy (including EGFR and ALK inhibitors) Tissue or Programmed death-ligand 1 (PD-L1) results available Cohort 1A Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) score 2 or Eastern Cooperative Oncology Group (ECOG) score 0-1 and one disease specific criteria as listed in the protocol Cohort C Inclusion Criteria: High Tumor Mutation Burden Exclusion Criteria: Untreated brain metastases An active malignancy that requires concurrent intervention Active, known or suspected autoimmune disease Carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer 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 - 0121
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Local Institution - 0148
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Local Institution - 0085
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Local Institution - 0164
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Local Institution - 0146
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Marin Cancer Care, Inc
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Los Angeles Hematology/Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Local Institution - 0115
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Torrance Health Association
City
Redondo Beach
State/Province
California
ZIP/Postal Code
90277
Country
United States
Facility Name
Va San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
Local Institution - 0143
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States
Facility Name
Local Institution - 0144
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Gene Upshaw Memorial Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Facility Name
Local Institution - 0161
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
Local Institution - 0083
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Local Institution - 0141
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Facility Name
Cancer Specialists of North FL
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Local Institution - 0082
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Local Institution - 0147
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Local Institution - 0163
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
Local Institution - 0002
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Local Institution - 0166
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Local Institution - 0088
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Local Institution - 0108
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Kentucky One Health St. Joseph East Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Local Institution - 0091
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Local Institution - 0089
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435-2150
Country
United States
Facility Name
Jackson Oncology Associates, Pllc
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Local Institution - 0077
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Local Institution - 0087
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Local Institution - 0170
City
Reno
State/Province
Nevada
ZIP/Postal Code
89511
Country
United States
Facility Name
Local Institution - 0156
City
Belleville
State/Province
New Jersey
ZIP/Postal Code
07109
Country
United States
Facility Name
Summit Medical Group
City
Florham Park
State/Province
New Jersey
ZIP/Postal Code
07932
Country
United States
Facility Name
Local Institution - 0142
City
Livingston
State/Province
New Jersey
ZIP/Postal Code
07039
Country
United States
Facility Name
Local Institution - 0167
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Local Institution - 0004
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Local Institution - 0012
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Local Institution - 0100
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Local Institution - 0134
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Local Institution - 0172
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Local Institution - 0096
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Local Institution - 0176
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Local Institution - 0139
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Local Institution - 0159
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Local Institution - 0001
City
Sayre
State/Province
Pennsylvania
ZIP/Postal Code
18840
Country
United States
Facility Name
Local Institution - 0123
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Local Institution - 0066
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Local Institution - 0067
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Local Institution - 0090
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Texas Oncology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Local Institution - 0149
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Local Institution - 0094
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Local Institution - 0093
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Name
Local Institution - 0098
City
Plano
State/Province
Texas
ZIP/Postal Code
75075-7787
Country
United States
Facility Name
Local Institution - 0086
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Local Institution - 0097
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Local Institution - 0044
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Local Institution - 0174
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Local Institution - 0173
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Local Institution - 0008
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0006
City
Viedma
State/Province
RIO Negro
ZIP/Postal Code
8500
Country
Argentina
Facility Name
Local Institution - 0007
City
Caba
ZIP/Postal Code
1199
Country
Argentina
Facility Name
Local Institution - 0009
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution - 0126
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution - 0038
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0037
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution - 0036
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Facility Name
Local Institution - 0152
City
Ijui
State/Province
RIO Grande DO SUL
ZIP/Postal Code
98700-000
Country
Brazil
Facility Name
Local Institution - 0154
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90610000
Country
Brazil
Facility Name
Local Institution - 0153
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Local Institution - 0151
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14780-070
Country
Brazil
Facility Name
Local Institution - 0127
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Local Institution - 0109
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Local Institution - 0049
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Facility Name
Local Institution - 0050
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
Local Institution - 0010
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
8420383
Country
Chile
Facility Name
Local Institution - 0011
City
Santiago
Country
Chile
Facility Name
Local Institution - 0133
City
Novy Jicin
ZIP/Postal Code
741 01
Country
Czechia
Facility Name
Local Institution - 0130
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution - 0118
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution - 0075
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Local Institution - 0069
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Local Institution - 0076
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Local Institution - 0074
City
Pessac cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution - 0071
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution - 0070
City
Saint Herblain
ZIP/Postal Code
44805
Country
France
Facility Name
Local Institution - 0072
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Local Institution - 0073
City
Toulon Cedex
ZIP/Postal Code
83056
Country
France
Facility Name
Local Institution - 0023
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Local Institution - 0028
City
Gera
ZIP/Postal Code
07548
Country
Germany
Facility Name
Local Institution - 0029
City
Kassel
ZIP/Postal Code
34125
Country
Germany
Facility Name
Local Institution - 0026
City
Loewenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Local Institution - 0025
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Local Institution - 0030
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution - 0031
City
N. Faliro
ZIP/Postal Code
18547
Country
Greece
Facility Name
Local Institution - 0032
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Local Institution - 0013
City
Gyöngyös - Mátraháza
State/Province
Heves
ZIP/Postal Code
3233
Country
Hungary
Facility Name
Local Institution - 0014
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Local Institution - 0054
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Ospedale Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
IRST Meldola
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
AOU della Campania Luigi Vanvitelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Degli Infermi
City
Rimini
ZIP/Postal Code
47923
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Ospedaliera Santa Maria Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Local Institution - 0019
City
Monterrey, NL
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Local Institution - 0045
City
Groningen
ZIP/Postal Code
9714 CZ
Country
Netherlands
Facility Name
Local Institution - 0035
City
Rotterdam
ZIP/Postal Code
3014 GD
Country
Netherlands
Facility Name
Local Institution - 0015
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Local Institution - 0068
City
Sucha Beskidzka
ZIP/Postal Code
34-200
Country
Poland
Facility Name
Local Institution - 0016
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution - 0128
City
Bucuresti
ZIP/Postal Code
021389
Country
Romania
Facility Name
Local Institution - 0119
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Name
Local Institution - 0120
City
Romania
ZIP/Postal Code
400015
Country
Romania
Facility Name
Local Institution - 0022
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution - 0021
City
Moscow
ZIP/Postal Code
121309
Country
Russian Federation
Facility Name
Local Institution - 0020
City
St Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
Local Institution - 0061
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution - 0060
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0062
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
Local Institution - 0065
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0064
City
Majadahonda - Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Local Institution - 0063
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution - 0059
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution - 0112
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Local Institution - 0048
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution - 0046
City
Zuerich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution - 0104
City
Antalya
ZIP/Postal Code
07070
Country
Turkey
Facility Name
Local Institution - 0041
City
London
State/Province
Greater London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Local Institution - 0039
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Local Institution - 0040
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Local Institution - 0043
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Local Institution - 0042
City
Wirral
ZIP/Postal Code
CH63 4JY
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
http://www.BMSStudyConnect.com
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

An Investigational Immuno-therapy Study for Safety of Nivolumab in Combination With Ipilimumab to Treat Advanced Cancers

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