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Trial record 1 of 1 for:    NCT02454179
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Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE147)

This study is ongoing, but not recruiting participants.
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Acerta Pharma BV Identifier:
First received: May 22, 2015
Last updated: November 30, 2016
Last verified: November 2016
Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Acerta Pharma BV:

Primary Outcome Measures:
  • The overall response rate (ORR) of pembrolizumab monotherapy and the combination of acalabrutinib and pembrolizumab in subjects with recurrent, metastatic or unresectable HNSCC [ Time Frame: 52 weeks ]

Estimated Enrollment: 74
Study Start Date: May 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT02454179

United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States
Sponsors and Collaborators
Acerta Pharma BV
Merck Sharp & Dohme Corp.
Study Director: Linda Bavisotto, MD Acerta Pharma
  More Information

Responsible Party: Acerta Pharma BV Identifier: NCT02454179     History of Changes
Other Study ID Numbers: ACE-ST-006
Study First Received: May 22, 2015
Last Updated: November 30, 2016

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents processed this record on May 24, 2017