Study on Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib for Treating Chronic Myeloid Leukemia with Minimal Residual Disease

Sponsor: ECOG-ACRIN Cancer Research Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03516279

Provider View

This clinical trial is exploring how well a combination of pembrolizumab with dasatinib, imatinib mesylate, or nilotinib works in treating patients with chronic myeloid leukemia (CML) who still have small amounts of cancer cells in their blood after treatment.

Patient Parameters

Program Overview

This study aims to find out if using pembrolizumab together with dasatinib, imatinib mesylate, or nilotinib can help patients with chronic myeloid leukemia (CML) who still have detectable cancer cells in their blood, known as minimal residual disease. Pembrolizumab is a type of monoclonal antibody that may help stop cancer cells from growing and spreading. The other drugs, dasatinib, imatinib mesylate, and nilotinib, work by blocking certain enzymes that cancer cells need to grow. The study will see if this combination is more effective in treating CML.

Description

The main goal of this study is to see how many patients with chronic myeloid leukemia (CML) can achieve undetectable levels of cancer cells in their blood after starting pembrolizumab treatment. Researchers will also look at how long these patients can maintain this status and whether they can stop taking their other cancer medications. The study will also monitor any serious side effects related to pembrolizumab.

Participants will receive pembrolizumab through an IV every 21 days, along with one of the other medications (dasatinib, imatinib mesylate, or nilotinib) as prescribed by their doctor. This treatment cycle can be repeated up to 18 times unless the disease progresses or side effects become unacceptable. If cancer cells are still detectable after 18 cycles, the treatment may continue for another 18 cycles. If cancer cells become undetectable before 18 cycles, pembrolizumab will be stopped after 18 cycles, but the other medication will continue.

After finishing the study treatment, participants will have follow-up visits every 6 months for up to 6 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of chronic phase chronic myeloid leukemia (CML) and be on a first-line tyrosine kinase inhibitor (TKI) for at least 2 years.
  • Must have detectable levels of the BCR-ABL gene product in the blood for at least 12 months, despite being in major molecular response (MMR).
  • Must not have achieved complete molecular remission (CMR) before starting the study.
  • Must be scheduled for a bone marrow biopsy within 7 days of pre-registration.
  • Must provide a blood sample for central testing to confirm eligibility.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must not have active hemolytic anemia requiring treatment.
  • Must not be using corticosteroids, except for low doses for non-cancer conditions.
  • Must not have another active primary cancer requiring treatment.
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception during and after the study.
  • Must have been on a stable dose of TKI for the last 3 months.
  • Must not be participating in another study or have used an investigational drug within 4 weeks.
  • Must not have a history of active tuberculosis or hypersensitivity to pembrolizumab.
  • Must not have received certain cancer treatments within 2 weeks before the study.
  • Must not have active central nervous system metastases or autoimmune disease requiring treatment in the past 2 years.
  • Must not have active infections or conditions that could interfere with the study.
  • Must not have received a live vaccine within 30 days before starting the study.
  • Must meet specific blood count and organ function criteria.
  • Must not be taking certain medications that could affect the study drugs.
  • Must not have had a prior allogeneic transplant.

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