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NCT05929664 · ClinicalTrials.gov registry record · Phase 2
Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery
A Phase 2 study of Locally Advanced Basal Cell Carcinoma, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 3
- Study locations
NCT05929664 is a Phase 2 study of Locally Advanced Basal Cell Carcinoma that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 70 participants. The trial reports 3 study locations across 3 states.
The verdict
NCT05929664, a Phase 2 study of Locally Advanced Basal Cell Carcinoma, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 3
- Study locations
Study Summary
A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Patients will undergo at least 2 and up to 6 infusions of immunotherapy prior to surgical resection. If patients have progression on neoadjuvant treatment, they may switch to standard of care surgical resection or hedgehog inhibitors prior to surgery. The primary endpoints are objective response rate and disease control rate. Safety and surgical benefit rate (de-escalation of surgery) with preservation of key anatomic structures are secondary endpoints. Correlative endpoints include analysis of pre and post treatment primary tumor and blood samples compared for histology, tumor genetics and immune cell composition.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- OTHER Quality-of-Life Assessment
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Cemiplimab
Study Locations (3)
Florida
- University of Miami Health System - Miami
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
Tennessee
- Vanderbilt University - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2023-07-05 |
| Est. Completion | 2027-07-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05929664
The ClinicalTrials.gov registry entry for NCT05929664 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Locally Advanced Basal Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05929664 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Florida, Pennsylvania, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05929664 about?
NCT05929664 is a clinical study titled "Cemiplimab Plus Fianlimab for the Treatment of Locally Advanced Head and Neck Basal Cell Carcinoma Before Surgery". A non-randomized two-cohort study of neoadjuvant Cemiplimab or neoadjuvant Cemiplimab plus Fianlimab (CF) in patients with basal cell carcinoma of the head and neck. Enrollment in the dual-therapy cohort will begin after completion of enrollment in the monotherapy cohort. Patients will undergo at le...
What is the current status of trial NCT05929664?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2023-07-05. Estimated completion is 2027-07-05.
What conditions does trial NCT05929664 study?
This clinical trial studies the following conditions: Locally Advanced Basal Cell Carcinoma.
What interventions are being tested in trial NCT05929664?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Quality-of-Life Assessment (OTHER), Magnetic Resonance Imaging (PROCEDURE), Cemiplimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05929664?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05929664 being conducted?
This trial has 3 study locations across Florida, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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