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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) logo

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)

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

Trial documents
2

Trial contacts and locations

21

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Data sourced from clinicaltrials.gov

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