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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 : Active, not recruiting
First Posted : May 27, 2015
Last Update Posted : December 1, 2016
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 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
Study Start Date : May 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm 1
pembrolizumab
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. 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 ]


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

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


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

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02454179     History of Changes
Other Study ID Numbers: ACE-ST-006
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Pembrolizumab
Antineoplastic Agents