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Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE147)

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ClinicalTrials.gov Identifier: NCT02454179
Recruitment Status : Completed
First Posted : May 27, 2015
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: pembrolizumab Drug: Acalabrutinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Advanced Head and Neck Squamous Cell Carcinoma
Actual Study Start Date : May 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1
Drug: pembrolizumab
Other Name: Keytruda

Experimental: Arm 2
acalabrutinib in combination with pembrolizumab
Drug: pembrolizumab
Other Name: Keytruda

Drug: Acalabrutinib
Other Name: ACP-196

Primary Outcome Measures :
  1. Number of Participants With Overall Response [ Time Frame: 52 weeks ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women ≥ 18 years of age
  • Histologically or cytologically confirmed recurrent, metastatic or unresectable HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that that has either progressed during or after platinum-based chemotherapy administered for metastatic disease or has recurred during or within 6 months after the completion of platinum-based neoadjuvant or adjuvant therapy
  • Presence of radiographically measurable disease as defined by RECIST 1.1
  • ECOG performance status of 0 or 1

Exclusion Criteria:

  • Prior malignancy (other than HNSCC), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to < 2 years
  • Known central nervous system metastases and/or carcinomatous meningitis
  • A life-threatening illness, medical condition (including psychiatric conditions) or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of starting study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454179

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United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
Sponsors and Collaborators
Acerta Pharma BV
Merck Sharp & Dohme LLC
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Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
  Study Documents (Full-Text)

Documents provided by Acerta Pharma BV:
Statistical Analysis Plan  [PDF] January 30, 2018
Study Protocol  [PDF] January 15, 2016

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02454179    
Other Study ID Numbers: ACE-ST-006
First Posted: May 27, 2015    Key Record Dates
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents, Immunological
Antineoplastic Agents