A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia

Completed · Phase 1

Conditions studied: Chronic Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT02011945

Run by

Bristol-Myers Squibb

People needed

35

Starts

2014-02-07

Expected to finish

2018-12-26

Last updated by the study team

2020-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Blast phase CML
• Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)

Where it is running

• Winship Cancer Institute — Atlanta, Georgia, United States
• Dana Farber Cancer Institute. — Boston, Massachusetts, United States
• Ut Southwestern Medical Center At Dallas — Dallas, Texas, United States
• The University Of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Froedtert Hospital & Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Local Institution — St Leonards, New South Wales, Australia
• Local Institution — Adelaide, South Australia, Australia
• Local Institution — Parkville, Victoria, Australia
• QEII Health Sciences Centre-VG Site — Halifax, Nova Scotia, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Hopital Maisonneuve-Rosemont — Montreal, Quebec, Canada
• Local Institution — Bordeaux, France
• Campus Virchow Klinikum Der Charite — Berlin, Germany
• Universitaetsklinikum Bonn — Bonn, Germany
• Universitaetsklinikum Carl Gustav Carus — Dresden, Germany
• Universitaetsklinik Frankfurt — Frankfurt am Main, Germany
• Local Institution — Naples, Italy
• Local Institution — Orbassano, Italy
• Local Institution — Roma, Italy
• Local Institution — Madrid, Spain
• Local Institution — Valencia, Spain

Full record on ClinicalTrials.gov

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