Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 2 study of Locally Advanced Basal Cell Carcinoma, sponsored by Thomas Jefferson University.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT05929664 shows while recruiting
NCT05929664 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Locally Advanced Basal Cell Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05929664's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00969111 · 70 participants · NA
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
- NCT01712620 · 70 participants · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
- NCT02143830 · 70 participants · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
- NCT02601339 · 70 participants
NIRS Monitoring in Premature Infants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI