Clinical trial NCT02011945: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Myeloid Leukemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-12-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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)

Primary outcomes:
measure: Incidence of Dose Limiting Toxicities (DLT)
timeFrame: Week 3 to week 6
measure: Incidence of Adverse Events (AEs)
timeFrame: Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing
measure: Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology
timeFrame: Up to 40 Months
measure: Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests
timeFrame: Up to 40 Months
measure: Incidence of Laboratory Abnormalities in Specific Thyroid Tests
timeFrame: Up to 40 Months
Secondary outcomes:
measure: Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
timeFrame: upto 36 Months
measure: Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
timeFrame: upto 36 Months
measure: Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
timeFrame: upto 36 Months
measure: Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
timeFrame: upto 36 Months
measure: Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
timeFrame: upto 36 Months
measure: Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
timeFrame: upto 36 Months
measure: Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
timeFrame: Up to 36 Months
measure: Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
timeFrame: Up to 36 Months
measure: Time to Major Molecular Response (MMR) - CML-AP Participants
timeFrame: Up to 36 Months
measure: Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
timeFrame: Up to 36 Months
measure: Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
timeFrame: Up to 36 Months
measure: Duration of Major Molecular Response (MMR) - CML-AP Participants
timeFrame: Up to 36 Months
measure: Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants
timeFrame: Up to 36 Months
measure: Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants
timeFrame: Up to 36 Months
measure: Time to Molecular Response 4.5(MR4.5) - CML-AP Participants
timeFrame: Up to 36 Months
measure: Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants
timeFrame: Up to 36 Months
measure: Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants
timeFrame: Up to 36 Months
measure: Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants
timeFrame: Up to 36 Months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Boston
country: United States
facility: Dana Farber Cancer Institute.
state: Massachusetts
city: Dallas
country: United States
facility: Ut Southwestern Medical Center At Dallas
state: Texas
city: Houston
country: United States
facility: The University Of Texas MD Anderson Cancer Center
state: Texas
city: Milwaukee
country: United States
facility: Froedtert Hospital & Medical College of Wisconsin
state: Wisconsin
city: St Leonards
country: Australia
facility: Local Institution
state: New South Wales
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Halifax
country: Canada
facility: QEII Health Sciences Centre-VG Site
state: Nova Scotia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Bordeaux
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Campus Virchow Klinikum Der Charite
city: Bonn
country: Germany
facility: Universitaetsklinikum Bonn
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinik Frankfurt
city: Napoli
country: Italy
facility: Local Institution
city: Orbassano
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: