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Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
NCT03969004 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cemiplimab
Study Locations (20)
California
- The Angeles Clinic — Los Angeles
- University of Southern California (USC) — Los Angeles
- Stanford Cancer Institute, Stanford Medicine at Stanford University — Palo Alto
- University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center — San Francisco
Florida
- University of Florida Health — Gainesville
- Sylvester Comprehensive Cancer Center — Miami
- Miami Cancer Institute at Baptist Health, Inc. — Miami
- University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute — Tampa
Arizona
- Banner MD Anderson Cancer Center — Gilbert
- Mayo Clinic Hospital — Phoenix
- Regeneron Study Site — Tucson
Massachusetts
- Massachusetts General Cancer Center — Boston
- Dana Farber/Harvard Cancer Center — Boston
District of Columbia
- George Washington University School of Medicine and Health Sciences — Washington D.C.
Georgia
- Regeneron Study Site — Atlanta
Illinois
- Regeneron Study Site — Chicago
Kentucky
- Regeneron Study Site — Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 415 participants |
| Start Date | 2019-06-04 |
| Est. Completion | 2028-03-26 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03969004
The ClinicalTrials.gov registry entry for NCT03969004 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 415 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 290 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Cutaneous Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03969004 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03969004 about?
NCT03969004 is a clinical study titled "Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma". The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: ...
What is the current status of trial NCT03969004?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 415 participants. The study started on 2019-06-04. Estimated completion is 2028-03-26.
What conditions does trial NCT03969004 study?
This clinical trial studies the following conditions: Cutaneous Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03969004?
The interventions under investigation include: Placebo (DRUG), Cemiplimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03969004?
This trial is sponsored by Regeneron Pharmaceuticals, which has 290 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03969004 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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