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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02011945




Registration number
NCT02011945
Ethics application status
Date submitted
21/11/2013
Date registered
16/12/2013
Date last updated
18/03/2020

Titles & IDs
Public 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
Scientific 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)
Secondary ID [1] 0 0
2013-002156-33
Secondary ID [2] 0 0
CA180-373
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: dasatinib Only - dasatinib 100 mg QD(CP) or 140 mg QD (AP)

Experimental: Dose Level 1 - Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)

Experimental: Dose Level 2 - Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Dose Limiting Toxicities (DLT)
Timepoint [1] 0 0
Week 3 to week 6
Primary outcome [2] 0 0
Incidence of Adverse Events (AEs)
Timepoint [2] 0 0
Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days
Primary outcome [3] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [3] 0 0
Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing
Primary outcome [4] 0 0
Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology
Timepoint [4] 0 0
Up to 40 Months
Primary outcome [5] 0 0
Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests
Timepoint [5] 0 0
Up to 40 Months
Primary outcome [6] 0 0
Incidence of Laboratory Abnormalities in Specific Thyroid Tests
Timepoint [6] 0 0
Up to 40 Months
Secondary outcome [1] 0 0
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Timepoint [1] 0 0
upto 36 Months
Secondary outcome [2] 0 0
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Timepoint [2] 0 0
upto 36 Months
Secondary outcome [3] 0 0
Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Timepoint [3] 0 0
upto 36 Months
Secondary outcome [4] 0 0
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
Timepoint [4] 0 0
upto 36 Months
Secondary outcome [5] 0 0
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
Timepoint [5] 0 0
upto 36 Months
Secondary outcome [6] 0 0
Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
Timepoint [6] 0 0
upto 36 Months
Secondary outcome [7] 0 0
Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
Timepoint [7] 0 0
Up to 36 Months
Secondary outcome [8] 0 0
Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
Timepoint [8] 0 0
Up to 36 Months
Secondary outcome [9] 0 0
Time to Major Molecular Response (MMR) - CML-AP Participants
Timepoint [9] 0 0
Up to 36 Months
Secondary outcome [10] 0 0
Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
Timepoint [10] 0 0
Up to 36 Months
Secondary outcome [11] 0 0
Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
Timepoint [11] 0 0
Up to 36 Months
Secondary outcome [12] 0 0
Duration of Major Molecular Response (MMR) - CML-AP Participants
Timepoint [12] 0 0
Up to 36 Months
Secondary outcome [13] 0 0
Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants
Timepoint [13] 0 0
Up to 36 Months
Secondary outcome [14] 0 0
Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants
Timepoint [14] 0 0
Up to 36 Months
Secondary outcome [15] 0 0
Time to Molecular Response 4.5(MR4.5) - CML-AP Participants
Timepoint [15] 0 0
Up to 36 Months
Secondary outcome [16] 0 0
Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants
Timepoint [16] 0 0
Up to 36 Months
Secondary outcome [17] 0 0
Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants
Timepoint [17] 0 0
Up to 36 Months
Secondary outcome [18] 0 0
Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants
Timepoint [18] 0 0
Up to 36 Months

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.



* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Blast phase CML
* Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/12/2018
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - St Leonards
Recruitment hospital [2] 0 0
Local Institution - Adelaide
Recruitment hospital [3] 0 0
Local Institution - Parkville
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
United States of America
State/province [4] 0 0
Wisconsin
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
Germany
State/province [9] 0 0
Berlin
Country [10] 0 0
Germany
State/province [10] 0 0
Bonn
Country [11] 0 0
Germany
State/province [11] 0 0
Dresden
Country [12] 0 0
Germany
State/province [12] 0 0
Frankfurt am Main
Country [13] 0 0
Italy
State/province [13] 0 0
Napoli
Country [14] 0 0
Italy
State/province [14] 0 0
Orbassano
Country [15] 0 0
Italy
State/province [15] 0 0
Roma
Country [16] 0 0
Spain
State/province [16] 0 0
Madrid
Country [17] 0 0
Spain
State/province [17] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02011945
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02011945