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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
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE May 22, 2015
First Posted Date  ICMJE May 27, 2015
Results First Submitted Date  ICMJE July 19, 2019
Results First Posted Date  ICMJE September 12, 2019
Last Update Posted Date September 12, 2019
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 22, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2015)
The overall response rate (ORR) of pembrolizumab monotherapy and the combination of ACP-196 and pembrolizumab in subjects with recurrent, metastatic or unresectable HNSCC [ Time Frame: 52 weeks ]
Change History Complete list of historical versions of study NCT02454179 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma
Official Title  ICMJE 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
Brief Summary Study of the combination of acalabrutinib (ACP-196) and pembrolizumab in subjects with advanced head and neck squamous cell carcinoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • Drug: pembrolizumab
    Other Name: Keytruda
  • Drug: Acalabrutinib
    Other Name: ACP-196
Study Arms  ICMJE
  • Experimental: Arm 1
    pembrolizumab
    Intervention: Drug: pembrolizumab
  • Experimental: Arm 2
    acalabrutinib in combination with pembrolizumab
    Interventions:
    • Drug: pembrolizumab
    • Drug: Acalabrutinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2019)
78
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2015)
74
Actual Study Completion Date  ICMJE July 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02454179
Other Study ID Numbers  ICMJE ACE-ST-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acerta Pharma BV
Study Sponsor  ICMJE Acerta Pharma BV
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
PRS Account Acerta Pharma BV
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP