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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Bristol-Myers Squibb
Study ID
NCT02011945
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 7, 2014
Status verified
Feb 2020
Primary completion
Dec 26, 2018
Completion
Dec 26, 2018

Study Design

Enrollment
35 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLT) [ Time Frame: Week 3 to week 6 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Winship Cancer InstituteAtlantaGeorgia30322-
Dana Farber Cancer Institute.BostonMassachusetts02215-
Ut Southwestern Medical Center At DallasDallasTexas75390-
The University Of Texas MD Anderson Cancer CenterHoustonTexas77030-
Froedtert Hospital & Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Atlanta, GA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Winship Cancer Institute· Atlanta, GADana Farber Cancer Institute.· Boston, MAUt Southwestern Medical Center At Dallas· Dallas, TXThe University Of Texas MD Anderson Cancer Center· Houston, TXFroedtert Hospital & Medical College of Wisconsin· Milwaukee, WI

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