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

NCT02454179 | Completed Phase 2 Results

• 1 other identifier: ACE-ST-006
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squamous Cell Carcinoma of the Head and Neck

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

pembrolizumab

Drug: pembrolizumab

Arm 2

EXPERIMENTAL

acalabrutinib in combination with pembrolizumab

Drug: pembrolizumab; Drug: Acalabrutinib

Interventions

pembrolizumab DRUG

Also known as: Keytruda

Arm 1; Arm 2

Acalabrutinib DRUG

Also known as: ACP-196

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acerta Pharma BV: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab; acalabrutinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Priti Patel, MD, Executive Director - Head of Clinical Development
• Organization: Acerta Pharma, LLC

acertamc@dlss.com

1-888-292-9613

Study Officials

• Acerta Clinical Trials

  1-888-292-9613; acertamc@dlss.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2015
• First Posted: May 27, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: September 12, 2019
• Results First Posted: September 12, 2019

Record last verified: 2019-08

Locations

US (1)