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NCT04428671 · ClinicalTrials.gov registry record · Phase 1
Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer
A Phase 1 study of Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04428671: Recruiting Phase 1 study of Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma, sponsored by Emory University.
NCT04428671 is a Phase 1 study of Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma that is actively recruiting participants, run by Emory University. The registered enrollment target is 20 participants, below the 63-participant average among 5 other Metastatic Skin Squamous Cell Carcinoma trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04428671, a Phase 1 study of Metastatic Skin Squamous Cell Carcinoma and Recurrent Skin Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cemiplimab before surgery may improve risk of the cancer returning in patients with high risk cutaneous squamous cell cancer.
Primary Outcome
Defined as the number of complete and partial responses divided by the total number of patients, as assessed by pathology. Pathological complete response (pCR) (no viable tumor) or pathological partial response (pPR) (less than 50% viable tumor) as well as near pCR (less than 10% viable tumor) in the tumor bed will be documented by pathology from the resection specimen. Pathologic response rate will be summarized using frequency and percentage, and a 95% exact confidence interval will be reporte
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- BIOLOGICAL Cemiplimab
- PROCEDURE Therapeutic Conventional Surgery
Study Locations (1)
Georgia
- Emory University/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-05-15 |
| Est. Completion | 2031-10-01 |
| Phase | Phase 1 |
What NCT04428671 shows while recruiting
NCT04428671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 63-participant average among 5 other Metastatic Skin Squamous Cell Carcinoma trials with a reported enrollment target (68% lower).
The record links to 2 conditions, with Metastatic Skin Squamous Cell Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT04428671 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT04428671 about?
NCT04428671 is a clinical study titled "Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squamous Cell Cancer". This phase I trial studies how well cemiplimab before and after surgery works in treating patients with high risk cutaneous squamous cell cancer. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of t...
What is the current status of trial NCT04428671?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-05-15. Estimated completion is 2031-10-01.
What conditions does trial NCT04428671 study?
This clinical trial studies the following conditions: Metastatic Skin Squamous Cell Carcinoma, Recurrent Skin Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04428671?
The interventions under investigation include: Radiation Therapy (RADIATION), Cemiplimab (BIOLOGICAL), Therapeutic Conventional Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT04428671?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04428671 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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