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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

Must not have

Patient has a known additional malignancy that is progressing or requires active treatment

Known active central nervous system metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have another cancer that is getting worse or needs treatment.

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I have cancer that has spread to my brain or spinal cord.

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I have a history of lung inflammation not caused by an infection.

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I am currently on medication for an infection.

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I have an active tuberculosis infection.

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I have a history of cancer.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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I have not received a live vaccine in the last 30 days.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I have had a transplant from another person.

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I have had a condition where lymphocytes are produced in excessive amounts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients on tyrosine kinase inhibitor (TKI) who convert to undetectable minimal residual disease (UMRD)

Secondary study objectives

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 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Systemic infection

Clostridium difficile colitis

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 3

~3150

Dasatinib

2012

Completed Phase 3

~2320