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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

NCT02011945

Description:

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.

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title:A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
  • Official Title:A Phase 1B Dose Escalation Study to Investigate the Safety, Tolerability and Preliminary Efficacy for the Combination Dasatinib (BMS-354825) Plus Nivolumab (BMS-936558) in Patients Chronic Myeloid Leukemia (CML)

Clinical Trial IDs

  • ORG STUDY ID: CA180-373
  • SECONDARY ID: 2013-002156-33
  • NCT ID: NCT02011945

Trial Conditions

  • Chronic Myeloid Leukemia

Trial Interventions

DrugSynonymsArms
DasatinibBMS-354825Arm 1: Dasatinib + Nivolumab
NivolumabBMS-936558Arm 1: Dasatinib + Nivolumab

Trial Purpose

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.

Detailed Description

Trial Arms

NameTypeDescriptionInterventions
Arm 1: Dasatinib + NivolumabExperimentalDose Escalation Phase: Dasatinib [100 mg Chronic Phase (CP) OR 140 mg Accelerated Phase (AP)] Tablet orally, once daily (QD), maximum 2 years of administration of the combination Dasatinib plus Nivolumab and up to maximum 1 year of single agent Dasatinib after last dose of Nivolumab Nivolumab (Dose level -1: 0.3 mg/kg, Dose level 1: 1 mg/kg, Dose level 2: 3 mg/kg) Intravenous (IV) Injection every 2 weeks (q 2 weeks) maximum 2 years of administration of the combination Dasatinib plus Nivolumab and up to maximum 1 year of single agent Dasatinib after last dose of Nivolumab Expansion Phase: Dasatinib: Same as in Dose Escalation phase Nivolumab: Dose selected on the basis of safety determination Dose Escalation Phase
  • Dasatinib
  • Nivolumab

Eligibility 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)

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and Tolerability for the combination of Dasatinib and Nivolumab
Time Frame:Up to 2 years (approximately)
Safety Issue:Yes
Description:Measured by the Dose limiting Toxicities determined based on the incidence and intensity of selected drug related adverse events, Incidences of Adverse events, Incidences of Serious adverse events, and Frequencies of abnormal Laboratory tests (summarized by worst toxicity grade)

Secondary Outcome Measures

Measure:Major Molecular Response (MMR) and Molecular Response (MR) rates
Time Frame:6, 12, 24, and 36 month
Safety Issue:No
Description:Based on MMR is defined as >= 3-log reduction in BCR-ABL transcripts or a ratio of <= 0.1% on the International Scale (IS) MR is defined as 4.5-log reduction in BCR-ABL transcripts or a ratio of 0.00316% on the IS
Measure:Time to, and duration of, MMR and MR
Time Frame:up to maximum 36 months
Safety Issue:No
Description:

Trial Keywords