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NCT03969004 · ClinicalTrials.gov registry record · Phase 3
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
A Phase 3 study of Cutaneous Squamous Cell Carcinoma, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 415
- Enrollment target
- 20
- Study locations
NCT03969004: Active Phase 3 study of Cutaneous Squamous Cell Carcinoma, sponsored by Regeneron Pharmaceuticals.
NCT03969004 is a Phase 3 study of Cutaneous Squamous Cell Carcinoma that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 415 participants, above the 69-participant average among 18 other Cutaneous Squamous Cell Carcinoma trials with a reported enrollment target (501% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03969004, a Phase 3 study of Cutaneous Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 415 participants
- Enrollment target
- 20
- Study locations
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
Primary Outcome
For patients who do not have a tumor recurrence or death, DFS will be censored on the date of last disease assessment.
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 |
What the registry record for NCT03969004 still lists
NCT03969004 is an interventional study that assigns participants to a tested intervention. The registered 415 participants enrollment target is mid-sized for trials with a published cap, above the 69-participant average among 18 other Cutaneous Squamous Cell Carcinoma trials with a reported enrollment target (501% higher).
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.
NCT03969004 names 20 study sites across 11 states, led by California, Florida, Arizona.
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.
What interventions are being tested in trial NCT03969004?
The interventions under investigation include: Placebo (DRUG), Cemiplimab (DRUG).
Who is sponsoring clinical trial NCT03969004?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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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participants (enrollment target), bucketed by value
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