CA180-373 = A Phase 1B Study with Dasatinib plus Nivolumab in CML

Type of study

Other trials

Current status

No longer recruiting patients

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)

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.

What will happen during the study

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