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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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)
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Secondary ID [1]
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2013-002156-33
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Secondary ID [2]
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CA180-373
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Myeloid Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dasatinib
Treatment: Drugs - Nivolumab
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)
Treatment: Drugs: Dasatinib
Treatment: Drugs: Nivolumab
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Dose Limiting Toxicities (DLT)
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Assessment method [1]
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DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs:
Grade 4 hematologic AE lasting > 7 days despite appropriate medical intervention, except as noted below;
Grade 3 or Grade 4 nonhematologic AE irrespective of duration;
Grade 2 nonhematologic AE lasting > 7 days despite appropriate medical intervention (exception: asymptomatic laboratory values of Grade 2 which do not require medical intervention);
Any toxicity managed by discontinuation of nivolumab;
Grade = 2 AE not controlled by medical intervention and requiring dasatinib treatment interruption for > 28 consecutive days;
Grade = 2 AE not controlled by medical intervention and requiring missing 2 consecutive doses of nivolumab.
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Timepoint [1]
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Week 3 to week 6
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Primary outcome [2]
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Incidence of Adverse Events (AEs)
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Assessment method [2]
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Any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not considered related to the investigational product.
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Timepoint [2]
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Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days
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Primary outcome [3]
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Incidence of Serious Adverse Events (SAEs)
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Assessment method [3]
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Any untoward medical occurrence that at any dose: results in death, is life threatening, requires in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is a important medical event.Requires inpatient hospitalization or causes prolongation of existing hospitalization, results.
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Timepoint [3]
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Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing
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Primary outcome [4]
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Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology
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Assessment method [4]
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The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology
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Timepoint [4]
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Up to 40 Months
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Primary outcome [5]
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Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests
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Assessment method [5]
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The number of participants with an abnormal Liver function test.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
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Timepoint [5]
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Up to 40 Months
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Primary outcome [6]
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Incidence of Laboratory Abnormalities in Specific Thyroid Tests
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Assessment method [6]
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Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
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Timepoint [6]
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Up to 40 Months
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Secondary outcome [1]
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Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
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Assessment method [1]
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Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as = 3-log reduction in BCR-ABL transcripts or a ratio of = 0.1% on the International Scale (IS).
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Timepoint [1]
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upto 36 Months
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Secondary outcome [2]
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Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
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Assessment method [2]
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Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as = 3-log reduction in BCR-ABL transcripts or a ratio of = 0.1% on the International Scale (IS).
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Timepoint [2]
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upto 36 Months
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Secondary outcome [3]
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Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
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Assessment method [3]
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Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
MMR is defined as = 3-log reduction in BCR-ABL transcripts or a ratio of = 0.1% on the International Scale (IS).
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Timepoint [3]
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upto 36 Months
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Secondary outcome [4]
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Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants
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Assessment method [4]
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Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as = 4.5-log reduction in BCR-ABL transcripts or a ratio of = 0.00316% on the International Scale (IS).
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Timepoint [4]
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upto 36 Months
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Secondary outcome [5]
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Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants
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Assessment method [5]
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Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as = 4.5-log reduction in BCR-ABL transcripts or a ratio of = 0.00316% on the International Scale (IS).
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Timepoint [5]
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upto 36 Months
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Secondary outcome [6]
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Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants
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Assessment method [6]
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Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (RQ-PCR).
A molecular response 4.5 (MR4.5) was defined as = 4.5-log reduction in BCR-ABL transcripts or a ratio of = 0.00316% on the International Scale (IS).
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Timepoint [6]
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upto 36 Months
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Secondary outcome [7]
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Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
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Assessment method [7]
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measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
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Timepoint [7]
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Up to 36 Months
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Secondary outcome [8]
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Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
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Assessment method [8]
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measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
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Timepoint [8]
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Up to 36 Months
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Secondary outcome [9]
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Time to Major Molecular Response (MMR) - CML-AP Participants
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Assessment method [9]
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measured from the date of first dosing until measurement criteria are first met for MMR. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
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Timepoint [9]
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Up to 36 Months
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Secondary outcome [10]
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Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants
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Assessment method [10]
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will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
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Timepoint [10]
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Up to 36 Months
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Secondary outcome [11]
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Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants
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Assessment method [11]
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will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
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Timepoint [11]
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Up to 36 Months
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Secondary outcome [12]
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Duration of Major Molecular Response (MMR) - CML-AP Participants
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Assessment method [12]
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will be computed for participants who have achieved MMR. It will be defined as the time from the first assessment in which MMR, is documented until the first assessment at which disease progression (or confirmed loss of MMR) is documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
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Timepoint [12]
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Up to 36 Months
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Secondary outcome [13]
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Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants
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Assessment method [13]
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measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
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Timepoint [13]
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Up to 36 Months
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Secondary outcome [14]
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Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants
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Assessment method [14]
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measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
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Timepoint [14]
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Up to 36 Months
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Secondary outcome [15]
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Time to Molecular Response 4.5(MR4.5) - CML-AP Participants
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Assessment method [15]
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measured from the date of first dosing until measurement criteria are first met for MR4.5. The participants who do not respond will be censored on the date of their last molecular assessment. It is defined for all treated participants.
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Timepoint [15]
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Up to 36 Months
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Secondary outcome [16]
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Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants
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Assessment method [16]
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will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
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Timepoint [16]
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0
Up to 36 Months
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Secondary outcome [17]
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0
Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants
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Assessment method [17]
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will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
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Timepoint [17]
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Up to 36 Months
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Secondary outcome [18]
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Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants
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Assessment method [18]
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will be computed for participants who have achieved MR4.5. It will be defined as the time from the first assessment in which MR4.5, is documented until the first assessment at which disease progression (or confirmed loss of MR4.5 documented. Participants who neither progress nor die will be censored on the date of their last molecular assessment
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Timepoint [18]
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Up to 36 Months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Blast phase CML
- Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/02/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/12/2018
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Local Institution - St Leonards
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Recruitment hospital [2]
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Local Institution - Adelaide
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Recruitment hospital [3]
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Local Institution - Parkville
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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Massachusetts
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Country [3]
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United States of America
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State/province [3]
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Texas
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Country [4]
0
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United States of America
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State/province [4]
0
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Wisconsin
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Country [5]
0
0
Canada
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State/province [5]
0
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Nova Scotia
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Country [6]
0
0
Canada
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State/province [6]
0
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Ontario
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Country [7]
0
0
Canada
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State/province [7]
0
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Quebec
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Country [8]
0
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France
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State/province [8]
0
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Bordeaux
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Country [9]
0
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Germany
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State/province [9]
0
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Berlin
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Country [10]
0
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Germany
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State/province [10]
0
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Bonn
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Country [11]
0
0
Germany
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State/province [11]
0
0
Dresden
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Country [12]
0
0
Germany
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State/province [12]
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Frankfurt am Main
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Country [13]
0
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Italy
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State/province [13]
0
0
Napoli
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Country [14]
0
0
Italy
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State/province [14]
0
0
Orbassano
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Country [15]
0
0
Italy
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State/province [15]
0
0
Roma
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Country [16]
0
0
Spain
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State/province [16]
0
0
Madrid
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Country [17]
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Spain
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State/province [17]
0
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02011945
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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0
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Phone
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Fax
0
0
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Email
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0
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Contact person for public queries
Name
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0
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Address
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0
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Country
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0
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Phone
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02011945
Download to PDF