CA180-373 = A Phase 1B Study with Dasatinib plus Nivolumab in CML
Study 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 [Australia, Europe, North America]
Scientific title
A Phase 1B Dose Escalation Study to Investigate the Safety, Tolerability and Preliminary Efficacy for the Combination of Dasatinib (BMS-354825) plus Nivolumab (BMS-936558) in Patients with Chronic Myeloid Leukemia (CML) (EudraCT 2013-002156-33, ClinicalTrials.gov NCT 02011945)
Type of study
Other trials
Current status
No longer recruiting patients
What is the purpose of the study
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.
Dasatinib [100 mg Chronic Phase (CP)] OR 140 mg Accelerated Phase (AP)] will be given as a tablet once daily for up to 2 years in combination with nivolumab which will be given as an intravenous injection every 2 weeks for up to 2 years. The dose of nivolumab will be increased on the basis of safety determinations. Administration of dasatinib will be continued for up to 1 year after the last dose of nivolumab.
Key inclusion criteria
Adult CML patients in chronic or accelerated phase and with documented Ph+ who were previously treated with two or more TKIs for CML and are currently progressing, resistant to or with a suboptimal response to their most recent therapy. Potential study participants have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score of 0–1.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Study sponsor
Bristol-Myers Squibb
Scientific lead / contact
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT02011945 and Site #.
Principal investigator
See site contact information
Study centers / principal investigators
Australia
New South Wales
Local Institution
St Leonards, New South Wales, 2065
Contact: Site 0021
South Australia
Local Institution
Adelaide, South Australia, 5000
Contact: Site 0006
Victoria
Local Institution
Parkville, Victoria, 3050
Contact: Site 0004
Canada
Nova Scotia
Qeii Health Sciences Centre-Vg Site
Halifax, Nova Scotia, B3H 2Y9
Contact: Site 0019
Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Contact: Site 0007
Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
Contact: Site 0022
Finland
Local Institution
Helsinki, 00029
Contact: Site 0001
Local Institution
Huch, 00029
Contact: Site 0023
Germany
Campus Virchow Klinikum Charité
13353 Berlin
Contact: Site 0027
Universitaetsklinikum Bonn,
53127 Bonn
Contact: Site 0016
Universitaetsklinkum Carl Gustav Carus
01307 Dresden
Contact: Site 0028
Universitaetsklinikum Frankfurt
60590 Frankfurt
Contact: Site 0015
Italy
Local Institution
Napoli, 80131
Contact: Site 0017
Local Institution
Orbassano, 10043
Contact: Site 0002
Local Institution
Roma, 00161
Contact: Site 0003
Spain
Local Institution
Madrid, 28047
Contact: Site 0012
Local Institution
Valencia, 46010
Contact: Site 0014
United States
Georgia
Winship Cancer Institute
Atlanta, Georgia, 30322
Contact: Site 0008
New York
Local Institution
Buffalo, New York, 14263
Contact: Site 0031
Ohio
Local Institution
Cleveland, Ohio, 44195
Contact: Site 0030
Texas
UT Southwestern Medical Center
Dallas, Texas, 75390
Contact: Site 0010
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Contact: Site 0024
Wisconsin
Froedert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Contact: Site 0029