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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 104 weeks

Awards & highlights

KEYNOTE145 Trial 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.Check my eligibility

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.See study design

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.

KEYNOTE145 Trial 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.

KEYNOTE145 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Duration of Response

Overall Response Rate

Overall Survival

+2 more

KEYNOTE145 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

~2030

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Acerta Pharma BVLead Sponsor

45 Previous Clinical Trials

5,764 Total Patients Enrolled

2 Trials studying Multiple Myeloma

67 Patients Enrolled for Multiple Myeloma

Merck Sharp & Dohme LLCIndustry Sponsor

3,886 Previous Clinical Trials

5,054,410 Total Patients Enrolled

37 Trials studying Multiple Myeloma

11,259 Patients Enrolled for Multiple Myeloma

Acerta Clinical TrialsStudy DirectorAcerta Pharma, LLC

17 Previous Clinical Trials

2,265 Total Patients Enrolled

1 Trials studying Multiple Myeloma

27 Patients Enrolled for Multiple Myeloma

Media Library

ACP-196 (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02362035 — Phase 1 & 2

Multiple Myeloma Research Study Groups: Acalabrutinib plus Pembrolizumab

Multiple Myeloma Clinical Trial 2023: ACP-196 Highlights & Side Effects. Trial Name: NCT02362035 — Phase 1 & 2

ACP-196 (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02362035 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many hospitals in this city are participating in the research project?

"20 different clinical sites are currently enrolling patients in this study, including ones located in Los Angeles, San Antonio and Fairfax. To lessen the burden of transportation while participating, we advise selecting a site nearest you."

Answered by AI

What precedent do we have for Acalabrutinib in terms of clinical research?

"Acalabrutinib was initially investigated in 2010 at City of Hope, with 270 trials now successfully completed. 1035 studies are currently being conducted throughout the country, primarily based out of Los Angeles, California."

Answered by AI

Is recruitment for this research program still open?

"As of now, this medical trial is not open for recruitment. It was first announced on February 20th 2015 and updated most recently in October 19th 2022. If you seek other opportunities, there are 5833 studies recruiting patients with multiple myeloma and 1035 trials actively accepting participants who wish to try Acalabrutinib."

Answered by AI

To what extent has patient participation been sought in the experiment?

"This medical study is no longer accepting participants, as the trial was last updated on October 19th 2022. However, if you are searching for other clinical trials related to multiple myeloma, there are presently 5833 active studies and 1035 trials with Acalabrutinib actively recruiting patients."

Answered by AI

Is Acalabrutinib typically prescribed to address a particular ailment?

"Acalabrutinib is used to treat a variety of neoplastic conditions, including malignant tumours and unresectable melanomas with high microsatellite instability."

Answered by AI

What are the overarching objectives of this clinical trial?

"According to Acerta Pharma BV, the principal efficacy endpoint will be Number of Participants With Any Grade 5 Study Drug-Related SAE and this metric will be tracked for 104 weeks. Additionally, secondary outcomes such as Time to Next Treatment, Overall Response Rate, and Duration of Response are being evaluated during the trial period."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02362035.

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