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NCT04323202 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant-Adjuvant Pembrolizumab in Resectable Advanced Basal Cell Carcinoma of H&N
A Phase 1 study of Basal Cell Carcinoma of the Head and Neck, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT04323202: Completed Phase 1 study of Basal Cell Carcinoma of the Head and Neck, sponsored by Case Comprehensive Cancer Center.
NCT04323202 is a Phase 1 study of Basal Cell Carcinoma of the Head and Neck that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04323202, a Phase 1 study of Basal Cell Carcinoma of the Head and Neck, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate anti-PD-1 Neoadjuvant therapy in Basal cell carcinoma to provide a better outcome when administered prior to surgery and provide a therapeutic strategy to avoid surgery altogether. The study team will gather information about how Basal cell carcinoma responds to Pembrolizumab prior to surgery and to gather information about recurrence rates. Pembrolizumab, is an investigational (experimental) drug that may improve the response of the immune system against cancer. Pembrolizumab is a manufactured antibody, much like the antibodies usually made by the human body to fight off infection. The idea behind developing this experimental drug is to stimulate the body's immune system to kill cancer cells. Pembrolizumab antibody has been specifically made to block a program cell death-1 (PD-1) protein receptor, which is found on cells of the immune system. PD-1 receptor seems to slow down the immune response. Blocking PD-1 with pembrolizumab antibody may make the immune response more active and may improve the response of the immune system against cancer. Pembrolizumab is currently FDA approved for use in other malignancies. It has been used to treat a number of other diseases such as certain types of lung cancer, cervical cancer and lymphoma. The use of Pembrolizumab in this study is experimental because it is not approved by the Food and Drug Administration (FDA) for use in the treatment of Basal cell carcinoma.
Primary Outcome
Pathologic response as assessed by change in tumor volume. Lesions measured between baseline and surgery using RECIST 1.1 criteria
Conditions Studied
Interventions
- DRUG Pembrolizumab
- OTHER Tissue collection
Study Locations (1)
Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-08-04 |
| Est. Completion | 2025-06-25 |
| Phase | Phase 1 |
What the finished NCT04323202 record still lists
NCT04323202 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Basal Cell Carcinoma of the Head and Neck appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04323202 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04323202 about?
NCT04323202 is a clinical study titled "Neoadjuvant-Adjuvant Pembrolizumab in Resectable Advanced Basal Cell Carcinoma of H&N". The purpose of this study is to evaluate anti-PD-1 Neoadjuvant therapy in Basal cell carcinoma to provide a better outcome when administered prior to surgery and provide a therapeutic strategy to avoid surgery altogether. The study team will gather information about how Basal cell carcinoma responds...
What is the current status of trial NCT04323202?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2020-08-04. Estimated completion is 2025-06-25.
What conditions does trial NCT04323202 study?
This clinical trial studies the following conditions: Basal Cell Carcinoma of the Head and Neck.
What interventions are being tested in trial NCT04323202?
The interventions under investigation include: Pembrolizumab (DRUG), Tissue collection (OTHER).
Who is sponsoring clinical trial NCT04323202?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04323202 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04323202's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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