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ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 (Acalabrutinib) and Pembrolizumab in Subjects With Hematologic Malignancies

NCT02362035•Acerta Pharma BV

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a Phase 1b/2, open-label, nonrandomized study that will be conducted in 2 stages. In the first stage, Part 1 of the study will determine the safety and preliminary efficacy of acalabrutinib and pembrolizumab in a limited group of B-cell malignancies. In the second stage, Part 2 allows for possible expansion cohorts into a wider range of B-cell malignancies, and Part 3 will evaluate the combination in subjects with myelofibrosis (MF).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of a hematologic malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO).
•Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
•Agreement to use contraception during the study and for 90 days after the last dose of ACP-196 or 120 days after the last dose of pembrolizumab, if sexually active and able to bear or beget children.
•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.
•ANC ≥ 0.5 x 10\^9/L or platelet count ≥ 50 x 10\^9/L unless due to disease involvement in the bone marrow.

Exclusion Criteria

•A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk.
•Central nervous system (CNS) involvement by lymphoma/leukemia
•Any therapeutic antibody within 4 weeks of first dose of study drugs.
•Total bilirubin \> 1.5 x ULN; and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3.0 x ULN.
•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.

Locations (19)

Research Site

Tucson, Arizona, United States

Research Site

Los Angeles, California, United States

Research Site

Denver, Colorado, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Niles, Illinois, United States

Research Site

Boston, Massachusetts, United States

Research Site

Rochester, Minnesota, United States

Research Site

Omaha, Nebraska, United States

Research Site

Columbus, Ohio, United States

Research Site

Greenville, South Carolina, United States

Key Dates

Start Date

February 20, 2015

Primary Completion Date

July 14, 2020

Completion Date

October 27, 2025

Last Updated

December 11, 2025

Enrollment

161

ACTUAL participants

Conditions

Follicular Lymphoma (FL)CLLSmall Lymphocytic Lymphoma (SLL)Richter's SyndromeMantle Cell Lymphoma (MCL)Indolent Non Hodgkin LymphomaWaldenström MacroglobulinemiaMultiple MyelomaHodgkin LymphomaBurkitt LymphomaMarginal Zone LymphomasMediastinal Large B Cell LymphomaHairy Cell Leukemia

Interventions

Acalabrutinib

DRUG

Pembrolizumab

DRUG

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NCT06859424

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

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RECRUITINGPHASE3

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

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Follicular Lymphoma (FL)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms

A Phase 1 Study of UB-VV111 With and Without Rapamycin in Relapsed/Refractory CD19+ B-cell Malignancies

Registry of the German CLL Study Group

Zanubrutinib and Venetoclax in CLL (ZANU-VEN)