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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-07

Study Completion Date

2018-12-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dasatinib Only

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

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Dose Level 1

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

Group Type EXPERIMENTAL

Dasatinib

Intervention Type DRUG

Nivolumab

Intervention Type DRUG

Dose Level 2

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

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BMS-354825 BMS-936558

Eligibility Criteria

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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