Clinical trial · Interventional
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
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)
NCT02011945CI-TRIAL-00044114completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- dasatinib Only
- description
- dasatinib 100 mg QD(CP) or 140 mg QD (AP)
- interventionNames
- Drug: Dasatinib
- type
- EXPERIMENTAL
- label
- Dose Level 1
- description
- Nivolumab 1 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
- interventionNames
- Drug: Dasatinib
- Drug: Nivolumab
- type
- EXPERIMENTAL
- label
- Dose Level 2
- description
- Nivolumab 3 mg/kg q 2 weeks + dasatinib 100 mg QD (CP) or 140 mg QD (AP)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.