Afatinib and Pembrolizumab for Head and Neck Squamous Cell Carcinoma (ALPHA Study) (ALPHA)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03695510 |
Recruitment Status :
Completed
First Posted : October 4, 2018
Last Update Posted : April 21, 2022
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Sponsor:
National Taiwan University Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
Tracking Information | |||||||
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First Submitted Date ICMJE | October 1, 2018 | ||||||
First Posted Date ICMJE | October 4, 2018 | ||||||
Last Update Posted Date | April 21, 2022 | ||||||
Actual Study Start Date ICMJE | January 24, 2019 | ||||||
Actual Primary Completion Date | April 14, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Objective response rate [ Time Frame: 2 years ] The objective response rate will be measured by RECIST 1.1.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Afatinib and Pembrolizumab for Head and Neck Squamous Cell Carcinoma (ALPHA Study) | ||||||
Official Title ICMJE | Afatinib and Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma, A Single-Arm, Phase II Study (ALPHA Study) | ||||||
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 Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Head and Neck Neoplasms | ||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Study arm
afatinib + pembrolizumab
Interventions:
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Publications * | Kao HF, Liao BC, Huang YL, Huang HC, Chen CN, Chen TC, Hong YJ, Chan CY, Chia JS, Hong RL. Afatinib and Pembrolizumab for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (ALPHA Study): A Phase II Study with Biomarker Analysis. Clin Cancer Res. 2022 Apr 14;28(8):1560-1571. doi: 10.1158/1078-0432.CCR-21-3025. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
29 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | April 14, 2022 | ||||||
Actual Primary Completion Date | April 14, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion criteria
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. 3.3.3 Exclusion criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 20 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Taiwan | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03695510 | ||||||
Other Study ID Numbers ICMJE | 201803071MIPD | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | National Taiwan University Hospital | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | National Taiwan University Hospital | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | National Taiwan University Hospital | ||||||
Verification Date | April 2022 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |