Acalabrutinib + Pembrolizumab for Blood Cancers

(KEYNOTE145 Trial)

Recruiting at 19 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.

Research Team

AstraZeneca Clinical Study Information Center

Principal Investigator

1-877-240-9479 - [e-mail]

Eligibility Criteria

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.

Inclusion Criteria

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

I agree to use birth control during and up to 4 months after the study if I can have children.

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

Exclusion Criteria

Your total bilirubin or liver enzymes are higher than the normal range.

I do not have a severe illness that could risk my safety in the study.

I haven't taken any therapeutic antibodies in the last 4 weeks.

Treatment Details

Interventions

• ACP-196 (Bruton's Tyrosine Kinase (BTK) Inhibitor)
• Pembrolizumab (PD-1 Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Acalabrutinib plus Pembrolizumab Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Acerta Pharma BV

Lead Sponsor

Trials

46

Recruited

5,900+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University