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)

Indication and most important 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.

Short description of intervention

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.

Type of study

 Other trials

Current status

No longer recruiting patients

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

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 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