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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Chronic Myeloid Leukemia

Treatments: Drug: Dasatinib; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02011945

CA180-373

2013-002156-33 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

dasatinib Only

Experimental group

Description:

dasatinib 100 mg QD(CP) or 140 mg QD (AP)

Treatment:

Drug: Dasatinib

Dose Level 1

Experimental group

Description:

Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)

Treatment:

Drug: Nivolumab

Drug: Dasatinib

Dose Level 2

Experimental group

Description:

Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)

Treatment:

Drug: Nivolumab

Drug: Dasatinib