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

Phase 2

Completed

• Conditions: Squamous Cell Carcinoma of the Head and Neck
• Interventions: Drug: pembrolizumab; Drug: Acalabrutinib

• Registration Number: NCT02454179
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-05-26
• Study First Posted: 2015-05-27
• Primary Completion: 2018-05
• Study Completion: 2018-07
• Results First Submitted: 2019-07-19
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-22
• Last Update Submitted: 2019-08-22
• Results First Posted: 2019-09-12
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	pembrolizumab	pembrolizumab
Arm 2	pembrolizumab	acalabrutinib in combination with pembrolizumab
Arm 2	Acalabrutinib	acalabrutinib in combination with pembrolizumab

Primary Outcome Measures

Name	Time	Method
Number of Participants With Overall Response	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.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States