Overview
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
Status:
Completed
Completed
Trial end date:
2018-12-26
2018-12-26
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbTreatments:
Antibodies, Monoclonal
Dasatinib
Nivolumab
Criteria
For more information regarding BMS clinical trial participation, please visitwww.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)