Afatinib and Pembrolizumab for Head and Neck Squamous Cell Carcinoma (ALPHA Study)

Phase 2

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: Afatinib Oral Tablet; Drug: Pembrolizumab Injection

• Registration Number: NCT03695510
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The primary objectives of the trial is to examine the toxicities and efficacies of afatinib and pembrolizumab for recurrent and/or metastatic head and neck squamous cell carcinoma.

Detailed Description

It is a single arm, phase II, single center, prospective, open label clinical trial.

Study Timeline

• Study First Submitted: 2018-10-01
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Study Start: 2019-01-24
• Status Verified: 2022-04
• Primary Completion: 2022-04-14
• Study Completion: 2022-04-14
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	Afatinib Oral Tablet	afatinib + pembrolizumab
Study arm	Pembrolizumab Injection	afatinib + pembrolizumab

Primary Outcome Measures

Name	Time	Method
Objective response rate	2 years	The objective response rate will be measured by RECIST 1.1.

Secondary Outcome Measures

Name	Time	Method
Toxicities	2 years	CTCAE 4.0, Grade 3 or higher
Overall survival	2 years	Overall survival: from the start of study treatment, to the time of death Progression free survival: from the start of study treatment, to the time of disease progression (RECIST 1.1) or death.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan