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NCT04315701 · ClinicalTrials.gov registry record · Phase 2
A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer
A Phase 2 study of Recurrent Skin Squamous Cell Carcinoma and Resectable Skin Squamous Cell Carcinoma, sponsored by University of Southern California.
- Active
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
- 5
- Study locations
NCT04315701: Active Phase 2 study of Recurrent Skin Squamous Cell Carcinoma and Resectable Skin Squamous Cell Carcinoma, sponsored by University of Southern California.
NCT04315701 is a Phase 2 study of Recurrent Skin Squamous Cell Carcinoma and Resectable Skin Squamous Cell Carcinoma that is active but no longer recruiting, run by University of Southern California. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04315701, a Phase 2 study of Recurrent Skin Squamous Cell Carcinoma and Resectable Skin Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by University of Southern California.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
- 5
- Study locations
Study Summary
This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by surgery (resectable). 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.
Primary Outcome
Defined by presence of \< 50% malignant cells. Descriptive statistics will be used to summarize the measurements.
Conditions Studied
Interventions
- BIOLOGICAL Cemiplimab
- PROCEDURE Resection
Study Locations (5)
California
- Los Angeles County-USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Hoag Memorial Hospital - Newport Beach
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Nebraska
- University of Nebraska - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2020-06-17 |
| Est. Completion | 2027-06-17 |
| Phase | Phase 2 |
What the registry record for NCT04315701 still lists
NCT04315701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 5 conditions, with Recurrent Skin Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Cemiplimab is the first listed.
NCT04315701 lists 5 locations in 3 states (California, Illinois, Nebraska).
Frequently Asked Questions
What is clinical trial NCT04315701 about?
NCT04315701 is a clinical study titled "A PD-1 Checkpoint Inhibitor (Cemiplimab) for High-Risk Localized, Locally Recurrent, or Regionally Advanced Skin Cancer". This phase II trial studies how well cemiplimab before surgery works in treating patients with skin cancer that is high-risk and has not spread to other parts of the body (localized), has come back locally (locally recurrent), or has spread regionally (regionally advanced), and can be removed by sur...
What is the current status of trial NCT04315701?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2020-06-17. Estimated completion is 2027-06-17.
What conditions does trial NCT04315701 study?
This clinical trial studies the following conditions: Recurrent Skin Squamous Cell Carcinoma, Resectable Skin Squamous Cell Carcinoma, Stage I Skin Cancer, Stage II Skin Cancer, Stage III Skin Cancer.
What interventions are being tested in trial NCT04315701?
The interventions under investigation include: Cemiplimab (BIOLOGICAL), Resection (PROCEDURE).
Who is sponsoring clinical trial NCT04315701?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04315701 being conducted?
This trial has 5 study locations across California, Illinois, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Skin Squamous 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 NCT04315701's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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
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