NCT03516279|Active Not RecruitingPhase 2DMCFDA Drug

Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

Phase II Study of Adding the Anti-PD-1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

ECOG-ACRIN Cancer Research Group ClinicalTrials.gov

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3 other identifiers

EA9171NCI-2017-02161U10CA180820

Study Type

interventional

Target

Locations

1 country

Sites

291

Timeline

RegisteredMay 2018

StartedJun 2019

CompletionAug 2031

Brief Summary

This phase II trial studies how well pembrolizumab and dasatinib, imatinib mesylate, or nilotinib work in treating patients with chronic myeloid leukemia and persistent detection of minimal residual disease, defined as the levels of a gene product called bcr-abl in the blood. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Dasatinib, imatinib mesylate, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and dasatinib, imatinib mesylate, or nilotinib may work better in treating patients with chronic myeloid leukemia.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

64mo left

Started Jun 2019

Longer than P75 for phase_2

Geographic Reach

1 country

291 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

12.2 years study duration

Study Progress56%

Jun 2019Aug 2031

First Submitted

Initial submission to the registry

April 24, 2018

Completed

10 days until next milestone

First Posted

Study publicly available on registry

May 4, 2018

Completed

1.1 years until next milestone

Study Start

First participant enrolled

June 26, 2019

Completed

9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2031

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

9.2 years

First QC Date

April 24, 2018

Last Update Submit

February 27, 2026

Conditions

Minimal Residual Disease Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Outcome Measures

Primary Outcomes (1)

Proportion of patients on tyrosine kinase inhibitor (TKI) who convert to undetectable minimal residual disease (UMRD)
Will be reported with exact confidence intervals. The binomial test will be used to test the null hypothesis that this proportion is 0.2 with the alternative hypothesis being that this proportion is greater than 0.2.
Up to 2 years of initiating pembrolizumab

Secondary Outcomes (5)

Proportion of patients who maintain UMRD for 6 months
Up to 6 years
Proportion of patients who maintain UMRD for 6 and 12 months
Up to 6 years
Proportion of patients who meet the criteria for discontinuing TKI
Up to 6 years
Proportion of patients who maintain UMRD for 2 years after first achieving UMRD
Up to 6 years
Proportion of patients who develop grade 3 or 4 immune related adverse events (not including grade 3 events that respond to corticosteroids and improve to grade 1 or less within 4 weeks)
Up to 6 years

Study Arms (1)

Treatment (pembrolizumab, dasatinib, imatinib, nilotinib)

EXPERIMENTAL

Patients receive pembrolizumab IV over 30 minutes on day 1 and dasatinib, imatinib mesylate, or nilotinib PO as clinically indicated per the treating physician. Treatment repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity. Patients with detectable MRD after course 18 continue pembrolizumab and dasatinib, imatinib mesylate, or nilotinib every 21 days for up to an additional 18 courses in the absence of disease progression or unacceptable toxicity. Patients with UMRD at any time before course 18 discontinue pembrolizumab after course 18 and continue dasatinib, imatinib mesylate, or nilotinib every 21 days for up to an additional 18 courses in the absence of disease progression or unacceptable toxicity.

Drug: DasatinibDrug: Imatinib MesylateOther: Laboratory Biomarker AnalysisDrug: NilotinibBiological: Pembrolizumab