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
Trial end date:
2018-12-26
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Antibodies, Monoclonal
Dasatinib
Nivolumab
Criteria
For more information regarding BMS clinical trial participation, please visit
www.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)