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Tyrosine Kinase Inhibitor
Pembrolizumab + TKI for Chronic Myeloid Leukemia
Phase 2
Recruiting
Led By Amer Zeidan
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient has not achieved CMR within the time of initiation of TKI therapy and pre-registration
Patient has pathologically-confirmed chronic phase-CML on a first line TKI for at least 2 years prior to pre-registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights
Study Summary
This trial is testing pembrolizumab with dasatinib, imatinib mesylate, or nilotinib to see if it can better treat chronic myeloid leukemia with minimal residual disease.
Who is the study for?
This trial is for chronic myeloid leukemia patients who've been on first-line TKI therapy for at least 2 years, are in MMR for over a year but haven't achieved complete molecular remission. They must have no active hemolytic anemia or other cancers, not be pregnant or breastfeeding, and agree to use contraception. Participants should have stable organ function and can't be on steroids or immunosuppressants.Check my eligibility
What is being tested?
The study tests if pembrolizumab combined with dasatinib, imatinib mesylate, or nilotinib is more effective than current treatments alone in chronic myeloid leukemia patients with minimal residual disease. It examines the effects of adding a monoclonal antibody (pembrolizumab) to existing enzyme-blocking cancer therapies.See study design
What are the potential side effects?
Possible side effects include immune system reactions that may affect organs like the lungs (pneumonitis), infusion-related reactions from pembrolizumab, fatigue, liver issues indicated by blood test changes, and increased risk of infections due to immune suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't reached complete molecular response since starting TKI therapy.
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I have chronic myeloid leukemia and have been on a first-line treatment for at least 2 years.
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I do not have an active blood disorder needing treatment.
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I am not currently using corticosteroids, except for low doses for non-blood related conditions.
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I have been on a consistent dose of TKI medication for the last 3 months.
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I do not have another cancer that needs treatment or shortens my life expectancy to 2 years or less.
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I am fully active or can carry out light work.
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I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients on tyrosine kinase inhibitor (TKI) who convert to undetectable minimal residual disease (UMRD)
Secondary outcome measures
Adrenal Cortex Hormones
Proportion of patients who maintain UMRD for 2 years after first achieving UMRD
Proportion of patients who maintain UMRD for 6 and 12 months
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, dasatinib, imatinib, nilotinib)Experimental Treatment5 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Dasatinib
2012
Completed Phase 3
~2320
Nilotinib
2005
Completed Phase 4
~2670
Imatinib Mesylate
2003
Completed Phase 4
~800
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,965 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
116 Previous Clinical Trials
176,882 Total Patients Enrolled
Amer ZeidanPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer that is getting worse or needs treatment.I have cancer that has spread to my brain or spinal cord.I have a history of lung inflammation not caused by an infection.I am currently on medication for an infection.I have not taken steroids or immunosuppressants in the last week.I am scheduled for a bone marrow biopsy within the next week.I have chronic myeloid leukemia and have been on a first-line treatment for at least 2 years.I have an active tuberculosis infection.I haven't reached complete molecular response since starting TKI therapy.My blood will be tested for the BCR/ABL gene.I have a history of cancer.I do not have an active blood disorder needing treatment.I am not currently using corticosteroids, except for low doses for non-blood related conditions.I have been on a consistent dose of TKI medication for the last 3 months.I do not have another cancer that needs treatment or shortens my life expectancy to 2 years or less.I haven't had cancer in the last 5 years, except for skin cancer.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have not received a live vaccine in the last 30 days.I have been in major molecular remission but still show signs of leukemia.I have not had chemotherapy, targeted therapy (except imatinib, dasatinib, or nilotinib), or radiation in the last 2 weeks.I have not needed treatment for an autoimmune disease in the last 2 years.I am fully active or can carry out light work.I have had a transplant from another person.I have received a cancer treatment drug within the last 4 weeks.I am not pregnant or breastfeeding.I have had a condition where lymphocytes are produced in excessive amounts.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, dasatinib, imatinib, nilotinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial recruiting participants at present?
"Affirmative. The information on clinicaltrials.gov reveals that this experiment is still open for enrollment, which was first advertised on October 3rd 2018 and recently modified on December 29th 2021. Approximately 40 participants are required from a full 100 research centres."
Answered by AI
What illnesses can be ameliorated by Pembrolizumab?
"Pembrolizumab is mainly prescribed to fight cancerous tumours. However, it has also proven effective in treating unresectable melanoma, microsatellite instability high cases and individuals at a heightened risk of relapse."
Answered by AI
What prior investigations have occurred pertaining to Pembrolizumab?
"Currently, there are 1079 active clinical trials for Pembrolizumab with 147 in the third phase. Most of these studies take place at Scottsdale, Arizona but there is a total of 41028 sites running tests on this drug."
Answered by AI
Has Pembrolizumab gained regulatory clearance from the FDA?
"While there is some evidence that Pembrolizumab can be utilised safely, the lack of clinical data regarding its efficacy results in a score of 2 on our assessment scale."
Answered by AI
What is the enrollment size of this clinical experiment?
"Affirmative. Clinicaltrials.gov's records demonstrate that recruitment for this research is currently in progress, with the initial post going live on October 3rd 2018 and the last amendment taking place on December 29th 2021. 40 participants across 100 sites are needed to complete the trial."
Answered by AI
Are there a multitude of sites conducting this clinical experiment in the city?
"Currently, this trial is seeking to recruit patients from a total of 100 medical sites across the globe. Carterville, Macomb and Dixon are among these locales in addition to other cities with participating centres. When selecting your location for enrolment, we suggest choosing the one nearest you to reduce travel costs."
Answered by AI
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