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
NCT02011945, Phase 1, Completed, Bristol-Myers Squibb; results first posted 2019-01-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia. Trials, record NCT02011945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02011945
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT02011945
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 35 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Chronic Myeloid Leukemia
- Interventions
- Dasatinib, Nivolumab
- First posted
- 2013-12-16
- Last updated
- 2020-03-18
- Other registries' IDs
- eudract:2013-002156-33
- Results first posted
- 2019-01-17
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Dose Limiting Toxicities (DLT) | Week 3 to week 6 | 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. |
| Primary | Incidence of Adverse Events (AEs) | Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days | 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. |
| Primary | Incidence of Serious Adverse Events (SAEs) | Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing | 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. |
| Primary | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Up to 40 Months | The number of participants with a shift in laboratory test results from baseline to Grade 3-4 in hematology |
| Primary | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | Up to 40 Months | The number of participants with an abnormal Liver function test. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) |
| Primary | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | Up to 40 Months | Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN) |
| Secondary | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | upto 36 Months | 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). |
| Secondary | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | upto 36 Months | 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). |
| Secondary | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | upto 36 Months | 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). |
| Secondary | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | upto 36 Months | 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). |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Dose Limiting Toxicities (DLT) | Week 3 to week 6 | All Treated Participants | Number of Incidence | NUMBER |
| PRIMARY | Incidence of Adverse Events (AEs) | Initiation of study drug to discontinuation of nivolumab stop date + 100 days or discontinuation of dasatinib + 30 days | All Treated Participants | Number of Adverse Events | NUMBER |
| PRIMARY | Incidence of Serious Adverse Events (SAEs) | Initiation of study drug to within 100 days of discontinuation of nivolumab dosing and 30 days of dasatinib dosing | All Treated Participants | Number of Adverse Events | NUMBER |
| PRIMARY | Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology | Up to 40 Months | All Treated Participants | Participants | NUMBER |
| PRIMARY | Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests | Up to 40 Months | All Treated Participants with at least one treatment measure | Participants | NUMBER |
| PRIMARY | Incidence of Laboratory Abnormalities in Specific Thyroid Tests | Up to 40 Months | All Treated Participants | Number of Incidences | NUMBER |
| SECONDARY | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | upto 36 Months | All treated Participants, CML-CP no prior Dasatinib participants | Percentage of Participants | NUMBER |
| SECONDARY | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants | upto 36 Months | All treated Participants, CML-CP prior Dasatinib participants | Percentage | NUMBER |
| SECONDARY | Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants | upto 36 Months | All treated Participants, CML-AP Participants | Percentage | NUMBER |
| SECONDARY | Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants | upto 36 Months | All treated Participants, CML-CP no prior Dasatinib participants | Percentage | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group170
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Dose Limiting Toxicities (DLT) | Dasatinib Only | 0 | Number of Incidence | ||
| Incidence of Dose Limiting Toxicities (DLT) | Dose Level 1 | 0 | Number of Incidence | ||
| Incidence of Dose Limiting Toxicities (DLT) | Dose Level 2 | 0 | Number of Incidence | ||
| Incidence of Adverse Events (AEs) | Dose Level 1 | CML-CP, No Prior dasatinib treatment | 1 | Number of Adverse Events | |
| Incidence of Adverse Events (AEs) | Dose Level 2 | CML-CP, No Prior dasatinib treatment | 2 | Number of Adverse Events | |
| Incidence of Adverse Events (AEs) | Dasatinib Only | CML-CP, Prior dasatinib treatment | 1 | Number of Adverse Events | |
| Incidence of Adverse Events (AEs) | Dose Level 1 | CML-CP, Prior dasatinib treatment | 8 | Number of Adverse Events | |
| Incidence of Adverse Events (AEs) | Dose Level 2 | CML-CP, Prior dasatinib treatment | 11 | Number of Adverse Events | |
| Incidence of Adverse Events (AEs) | Dose Level 1 | CML-AP participants | 4 | Number of Adverse Events | |
| Incidence of Adverse Events (AEs) | Dose Level 2 | CML-AP participants | 3 | Number of Adverse Events |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib Only | 2 | |
| Overall Study | STARTED | Dose Level 1 | 13 | |
| Overall Study | STARTED | Dose Level 2 | 16 | |
| Overall Study | COMPLETED | Dasatinib Only | 0 | |
| Overall Study | COMPLETED | Dose Level 1 | 3 | |
| Overall Study | COMPLETED | Dose Level 2 | 6 | |
| Overall Study | NOT COMPLETED | Dasatinib Only | 2 | |
| Overall Study | NOT COMPLETED | Dose Level 1 | 10 | |
| Overall Study | NOT COMPLETED | Dose Level 2 | 10 |
Source ClinicalTrials.gov
Adverse events705
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dasatinib Only | 0 | 2 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Level 1 | 4 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Dose Level 2 | 4 | 16 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dasatinib Only | 0 | 2 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dose Level 1 | 2 | 13 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dose Level 2 | 4 | 16 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dasatinib Only | 0 | 2 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose Level 1 | 3 | 13 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Dose Level 2 | 4 | 16 | |
| other | Ear pain | Ear and labyrinth disorders | Dasatinib Only | 0 | 2 |
1 to 10 of 705Source ClinicalTrials.gov
See all 705 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib Only | 0 | 2 |
| Total, all-cause mortality | Dose Level 1 | 2 | 13 |
| Total, all-cause mortality | Dose Level 2 | 0 | 16 |
| Total, other adverse events | Dasatinib Only | 1 | 2 |
| Total, other adverse events | Dose Level 1 | 13 | 13 |
| Total, other adverse events | Dose Level 2 | 16 | 16 |
| Total, serious adverse events | Dasatinib Only | 0 | 2 |
| Total, serious adverse events | Dose Level 1 | 7 | 13 |
| Total, serious adverse events | Dose Level 2 | 8 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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The record and each of its lists are JSON, twenty rows a page. No key.
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