Study of the Combination of Acalabrutinib (ACP-196) and Pembrolizumab in Advanced Head and Neck Squamous Cell Carcinoma (KEYNOTE147)

Acerta Pharma

Status and phase: Completed; Phase 2

Conditions: Squamous Cell Carcinoma of the Head and Neck

Treatments: Drug: pembrolizumab; Drug: Acalabrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02454179

ACE-ST-006

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Arm 1

Experimental group

Description:

pembrolizumab

Treatment:

Drug: pembrolizumab

Arm 2

Experimental group

Description:

acalabrutinib in combination with pembrolizumab

Treatment:

Drug: Acalabrutinib

Drug: pembrolizumab