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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 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.

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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

Conditions Studied

Cutaneous Squamous Cell Carcinoma

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

FieldValue
Enrollment Target 415 participants
Start Date 2019-06-04
Est. Completion 2028-03-26
Phase Phase 3

Sponsor

Regeneron Pharmaceuticals

280 total trials

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What the Registry Record Tells You About NCT03969004

The ClinicalTrials.gov registry entry for NCT03969004 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 415 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 69-participant average among 18 other Cutaneous Squamous Cell Carcinoma trials with a reported enrollment target (501% higher). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.