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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Squamous Cell Carcinoma of the Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

pembrolizumab

Group Type EXPERIMENTAL

pembrolizumab

Intervention Type DRUG

Arm 2

acalabrutinib in combination with pembrolizumab

Group Type EXPERIMENTAL

pembrolizumab

Intervention Type DRUG

Acalabrutinib

Intervention Type DRUG

Interventions

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pembrolizumab

Intervention Type DRUG

Acalabrutinib

Intervention Type DRUG

Other Intervention Names

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Keytruda ACP-196

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No