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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

— KEYNOTE147  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454179
• Other study ID #: ACE-ST-006
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: July 2018

Study information

• Verified date: August 2019
• Source: Acerta Pharma BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• pembrolizumab

• Acalabrutinib

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Acerta Pharma BV	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Overall Response	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.	52 weeks