NCT03516279

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Assess the proportion of chronic myelogenous leukemia (CML) patients on stable-dose tyrosine kinase inhibitor (TKI) who convert to undetectable minimal residual disease (UMRD) (molecular response \[MR\]\^4.5) during or within 2 years of initiating pembrolizumab therapy. SECONDARY OBJECTIVES: I. Among patients who have converted to UMRD (MR\^4.5), assess the proportion of CML patients who maintain UMRD for 6 months and 12 months. II. Among patients who have converted to UMRD (MR\^4.5), assess the proportion of CML patients who discontinue their TKI. III. Among patients who have converted to UMRD (MR\^4.5), assess the proportion of CML patients who are UMRD and TKI-free at 2 years from first determined UMRD. IV. Assess the proportion of CML patients who develop grade 3 or 4 immune related adverse events related to pembrolizumab treatment during the first 2 years after registration (not including grade 3 events that respond to corticosteroids and improve to grade 1 or less within 4 weeks). OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and dasatinib, imatinib mesylate, or nilotinib orally (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. After completion of study treatment, patients are followed up every 6 months for 6 years from the date of registration.

Conditions

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

Interventions

Type	Name	Description
DRUG	Dasatinib	Given PO
DRUG	Imatinib Mesylate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Nilotinib	Given PO
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2019-06-26
• Primary completion: 2028-08-31
• Completion: 2031-08-31
• First posted: 2018-05-04
• Last updated: 2026-04-03

Locations

291 sites across 1 country: United States

Regulatory

• FDA-regulated drug study