Phase 1 Completed N=31 Treatment

A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia

Acute Myeloid Leukemia

Source: ClinicalTrials.gov NCT02011945 ↗

Enrolled (actual)

Serious AEs

48.4%

Results posted

Jan 2019

Primary outcomePrimary: Incidence of Dose Limiting Toxicities (DLT) — 0; 0; 0 Number of Incidence

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Dose Limiting Toxicities (DLT)	0; 0; 0	—
PRIMARY Incidence of Adverse Events (AEs)	1; 2; 1; 8; 11; 4	—
PRIMARY Incidence of Serious Adverse Events (SAEs)	0; 2; 0; 3; 4; 4	—
PRIMARY Incidence of Change From Baseline in Clinical Laboratory Tests: Hematology	0; 2; 4; 0; 5; 4	—
PRIMARY Incidence of Abnormalities in Clinical Laboratory Tests: Liver Tests	0; 1; 1; 0; 0; 0	—
PRIMARY Incidence of Laboratory Abnormalities in Specific Thyroid Tests	0; 4; 4; 0; 3; 3	—
SECONDARY Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants	100; 0; 100; 0; 100; 0	—
SECONDARY Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants	0; 25; 18.2; 0; 25; 27.3	—
SECONDARY Rate of Major Molecular Response (MMR) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants	0; 33.3; 0; 66.7; 0; 66.7	—
SECONDARY Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), No Prior Dasatinib Participants	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Chronic Phase (CML-CP), Prior Dasatinib Participants	0; 0.0; 0.0; 0; 0.0; 0.0	—
SECONDARY Rate of Molecular Response 4.5 (MR4.5) : Chronic Myelogenous Leukemia - Advanced Phase (CML-AP) Participants	0.0; 0.0; 0.0; 0.0; 0.0; 0.0	—
SECONDARY Time to Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants	0.53; NA	—
SECONDARY Time to Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants	NA; NA; 35.45	—
SECONDARY Time to Major Molecular Response (MMR) - CML-AP Participants	NA; 5.54	—
SECONDARY Duration of Major Molecular Response (MMR) - CML-CP No Prior Dasatinib Participants	NA	—
SECONDARY Duration of Major Molecular Response (MMR) - CML-CP Prior Dasatinib Participants	NA; NA	—
SECONDARY Duration of Major Molecular Response (MMR) - CML-AP Participants	NA	—
SECONDARY Time to Molecular Response 4.5(MR4.5) - CML-CP No Prior Dasatinib Participants	35.25; NA	—
SECONDARY Time to Molecular Response 4.5(MR4.5) - CML-CP Prior Dasatinib Participants	NA; NA; NA	—
SECONDARY Time to Molecular Response 4.5(MR4.5) - CML-AP Participants	NA; NA	—
SECONDARY Duration of Molecular Response 4.5 (MR4.5) - CML-CP No Prior Dasatinib Participants	NA	—
SECONDARY Duration of Molecular Response 4.5 (MR4.5) - CML-CP Prior Dasatinib Participants	—	—
SECONDARY Duration of Molecular Response 4.5 (MR4.5) - CML-AP Participants	—	—

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02011945). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.