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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib + Pembrolizumab for Blood Cancers (KEYNOTE145 Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Completion of all therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥ 4 weeks before the start of study therapy

Diagnosis of a hematologic malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO)

Must not have

Central nervous system (CNS) involvement by lymphoma/leukemia

Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 104 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug combination to treat cancer.

Who is the study for?

This trial is for adults with various blood cancers who've finished any cancer treatments at least 4 weeks prior. They must be relatively healthy (ECOG ≤1), have certain blood cell counts, and agree to use contraception if they can have children. It's not for those with severe illnesses, high bilirubin or liver enzymes, brain involvement by cancer, recent antibody therapy, or very poor kidney function.

What is being tested?

The study tests the combination of Acalabrutinib and Pembrolizumab in treating different types of blood cancers. It aims to assess how safe this combo is, how it affects the body (pharmacodynamics), and its effectiveness against these malignancies.

What are the potential side effects?

Possible side effects from Acalabrutinib include headache, diarrhea, muscle pain; while Pembrolizumab may cause immune-related issues like inflammation in organs or skin problems. Both drugs could potentially lead to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I finished all my cancer treatments at least 4 weeks ago.

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I have been diagnosed with a blood cancer according to WHO standards.

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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

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

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My lymphoma/leukemia has spread to my brain or spinal cord.

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My kidneys are not functioning well, with a creatinine clearance rate of less than 30 mL/min.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 104 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants With AE Leading to Study Drug Delay

Number of Participants With AE Leading to Study Drug Discontinuation

Number of Participants With AE Leading to Study Drug Discontinuation, Modification or Delay

+13 more

Secondary study objectives

Duration of Response

Overall Response Rate

Overall Survival

+2 more

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: Acalabrutinib plus PembrolizumabExperimental Treatment2 Interventions

A nonrandomized study that will be conducted in 2 stages. In the first stage, (Safety), subjects will receive Acalabrutinib Dose A orally administered (PO) twice daily (BID) in combination with Pembrolizumab Dose B administered every 3 weeks (Q3W). The second stage was an expansion of Cohorts with the same dose regimen as the first stage. An additional expansion in subjects with Myelofibrosis was planned but not conducted.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

Pembrolizumab

2017

Completed Phase 3

~3130