Back to resultsA Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
Primary Purpose
Chronic Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Nivolumab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Myeloid Leukemia
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase :
- With historically documented Ph+ cells
- ≥2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML
- Currently progressing, resistance to or with a suboptimal response to their most recent therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1
Exclusion Criteria:
- Blast phase CML
- Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
Sites / Locations
- Winship Cancer Institute
- Dana Farber Cancer Institute.
- Ut Southwestern Medical Center At Dallas
- The University Of Texas MD Anderson Cancer Center
- Froedtert Hospital & Medical College of Wisconsin
- Local Institution
- Local Institution
- Local Institution
- QEII Health Sciences Centre-VG Site
- Princess Margaret Cancer Centre
- Hopital Maisonneuve-Rosemont
- Local Institution
- Campus Virchow Klinikum Der Charite
- Universitaetsklinikum Bonn
- Universitaetsklinikum Carl Gustav Carus
- Universitaetsklinik Frankfurt
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
dasatinib Only
Dose Level 1
Dose Level 2
Arm Description
dasatinib 100 mg QD(CP) or 140 mg QD (AP)
Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
Outcomes
Primary Outcome Measures
Incidence of Dose Limiting Toxicities (DLT)
DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs:
Grade 4 hematologic AE lasting > 7 days despite appropriate medical intervention, except as noted below;
Grade 3 or Grade 4 nonhematologic AE irrespective of duration;
Grade 2 nonhematologic AE lasting > 7 days despite appropriate medical intervention (exception: asymptomatic laboratory values of Grade 2 which do not require medical intervention);
Any toxicity managed by discontinuation of nivolumab;
Grade ≥ 2 AE not controlled by medical intervention and requiring dasatinib treatment interruption for > 28 consecutive days;
Grade ≥ 2 AE not controlled by medical intervention and requiring missing 2 consecutive doses of nivolumab.
Incidence of Adverse Events (AEs)
Any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Incidence of Serious Adverse Events (SAEs)
Any untoward medical occurrence that at any dose: results in death, is life threatening, requires in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a important medical event.Requires inpatient hospitalization or causes prolongation of existing hospitalization, results.
Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology
The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology
Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests
The number of participants with an abnormal Liver function test.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
Incidence of Laboratory Abnormalities in Specific Thyroid Tests
Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
Secondary Outcome Measures
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time to Major Molecular Response (MMR) - CML-AP Participants
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Duration of Major Molecular Response (MMR) - CML-AP Participants
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time to Molecular Response 4.5(MR4.5) - CML-AP Participants
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02011945
Brief Title
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
Official Title
A Phase 1B Dose Escalation Study to Investigate the Safety, Tolerability and Preliminary Efficacy for the Combination Dasatinib (BMS-354825) Plus Nivolumab (BMS-936558) in Patients Chronic Myeloid Leukemia (CML)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 7, 2014 (Actual)
Primary Completion Date
December 26, 2018 (Actual)
Study Completion Date
December 26, 2018 (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
The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dasatinib Only
Arm Type
Experimental
Arm Description
dasatinib 100 mg QD(CP) or 140 mg QD (AP)
Arm Title
Dose Level 1
Arm Type
Experimental
Arm Description
Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
Arm Title
Dose Level 2
Arm Type
Experimental
Arm Description
Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
BMS-354825
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
BMS-936558
Primary Outcome Measure Information:
Title
Incidence of Dose Limiting Toxicities (DLT)
Description
DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs:
Grade 4 hematologic AE lasting > 7 days despite appropriate medical intervention, except as noted below;
Grade 3 or Grade 4 nonhematologic AE irrespective of duration;
Grade 2 nonhematologic AE lasting > 7 days despite appropriate medical intervention (exception: asymptomatic laboratory values of Grade 2 which do not require medical intervention);
Any toxicity managed by discontinuation of nivolumab;
Grade ≥ 2 AE not controlled by medical intervention and requiring dasatinib treatment interruption for > 28 consecutive days;
Grade ≥ 2 AE not controlled by medical intervention and requiring missing 2 consecutive doses of nivolumab.
Time Frame
Week 3 to week 6
Title
Incidence of Adverse Events (AEs)
Description
Any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
Time Frame
Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days
Title
Incidence of Serious Adverse Events (SAEs)
Description
Any untoward medical occurrence that at any dose: results in death, is life threatening, requires in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a important medical event.Requires inpatient hospitalization or causes prolongation of existing hospitalization, results.
Time Frame
Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing
Title
Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology
Description
The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology
Time Frame
Up to 40 Months
Title
Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests
Description
The number of participants with an abnormal Liver function test.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
Time Frame
Up to 40 Months
Title
Incidence of Laboratory Abnormalities in Specific Thyroid Tests
Description
Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
Time Frame
Up to 40 Months
Secondary Outcome Measure Information:
Title
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Description
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Time Frame
upto 36 Months
Title
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Description
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Time Frame
upto 36 Months
Title
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Description
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as ≥ 3-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.1% on the International Scale (IS).
Time Frame
upto 36 Months
Title
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Description
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Time Frame
upto 36 Months
Title
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Description
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Time Frame
upto 36 Months
Title
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Description
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as ≥ 4.5-log reduction in BCR-ABL transcripts or a ratio of ≤ 0.00316% on the International Scale (IS).
Time Frame
upto 36 Months
Title
Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
Description
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time Frame
Up to 36 Months
Title
Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
Description
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time Frame
Up to 36 Months
Title
Time to Major Molecular Response (MMR) - CML-AP Participants
Description
measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time Frame
Up to 36 Months
Title
Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
Description
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time Frame
Up to 36 Months
Title
Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
Description
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time Frame
Up to 36 Months
Title
Duration of Major Molecular Response (MMR) - CML-AP Participants
Description
will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time Frame
Up to 36 Months
Title
Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants
Description
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time Frame
Up to 36 Months
Title
Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants
Description
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time Frame
Up to 36 Months
Title
Time to Molecular Response 4.5(MR4.5) - CML-AP Participants
Description
measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
Time Frame
Up to 36 Months
Title
Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants
Description
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time Frame
Up to 36 Months
Title
Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants
Description
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time Frame
Up to 36 Months
Title
Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants
Description
will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
Time Frame
Up to 36 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase :
With historically documented Ph+ cells
≥2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML
Currently progressing, resistance to or with a suboptimal response to their most recent therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1
Exclusion Criteria:
Blast phase CML
Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
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
Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Dana Farber Cancer Institute.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Ut Southwestern Medical Center At Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
The University Of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Froedtert Hospital & Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
QEII Health Sciences Centre-VG Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Campus Virchow Klinikum Der Charite
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitaetsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitaetsklinik Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46010
Country
Spain
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/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
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