This trial is active, not recruiting.

Condition squamous cell carcinoma of the head and neck
Treatments pembrolizumab, acalabrutinib
Phase phase 2
Targets BTK, PD-1
Sponsor Acerta Pharma BV
Collaborator Merck Sharp & Dohme Corp.
Start date May 2015
End date September 2017
Trial size 74 participants
Trial identifier NCT02454179, ACE-ST-006


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

United States Oregon
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
pembrolizumab Keytruda
acalabrutinib in combination with pembrolizumab
pembrolizumab Keytruda
acalabrutinib ACP-196

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Acerta Pharma BV.
Location data was received from the National Cancer Institute and was last updated in November 2016.