Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT03969004
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — DRUG
    Intravenous (IV) infusion over 30 minutes
  • Placebo — DRUG
    Intravenous (IV) infusion over 30 minutes

Study Details

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

Key Dates

Start date
Jun 4, 2019
Status verified
Mar 2026
Primary completion
Jan 7, 2028
Completion
Jan 7, 2028

Study Design

Enrollment
415 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab
  • Placebo Comparator: Placebo

Primary Outcome Measure

DFS defined as time from randomization to the first documented disease recurrence (local, regional and/or distant); or death due to any cause. [ Time Frame: Up to 54 months ]

Locations (40)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Mayo Clinic HospitalPhoenixArizona85054-
Regeneron Study SiteTucsonArizona85724-5024-
The Angeles ClinicLos AngelesCalifornia90025-
University of Southern California (USC)Los AngelesCalifornia90033-
Stanford Cancer Institute, Stanford Medicine at Stanford UniversityPalo AltoCalifornia94304-
University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94143-0981-
George Washington University School of Medicine and Health SciencesWashington D.C.District of Columbia20037-
University of Florida HealthGainesvilleFlorida032608-
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
Regeneron Study SiteAtlantaGeorgia30342-
Regeneron Study SiteChicagoIllinois60611-
Regeneron Study SiteLouisvilleKentucky40202-
Regeneron Study SiteBaltimoreMaryland21287-
Dana Farber/Harvard Cancer CenterBostonMassachusetts02215-
Massachusetts General Cancer CenterBostonMassachusetts02114-
Michigan Medicine- University of MichiganAnn ArborMichigan48109-
University of Missouri Health Care - University Physicians - Medicine Specialty ClinicColumbiaMissouri65212-
Washington University in Saint LouisSt LouisMissouri63110-
Nebraska Methodist HospitalOmahaNebraska68114-
Memorial Sloan KetteringBasking RidgeNew Jersey07920-
Memorial Sloan KetteringMiddletownNew Jersey07748-
Memorial Sloan KetteringMontvaleNew Jersey07645-
Memorial Sloan KetteringNew BrunswickNew Jersey08903-
Memorial Sloan KetteringCommackNew York11725-
Memorial Sloan KetteringHarrisonNew York10604-
Columbia UniversityNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
NYU Langone HealthNew YorkNew York10016-
Memorial Sloan KetteringUniondaleNew York11553-
Regeneron Research SiteCincinnatiOhio45267-
The Ohio State UniversityGahannaOhio43230-
Penn State Hershey Children's HospitalHersheyPennsylvania17025-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Sarah Cannon Research Institute - Tennessee OncologyNashvilleTennessee37203-
Texas Oncology - Baylor Charles A. Simmons Cancer CenterDallasTexas75246-
UT Southwestern Medical CenterDallasTexas75390-
University Of Virginia Health SystemCharlottesvilleVirginia22908-

Find similar trials in Gilbert, AZ

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Banner MD Anderson Cancer Center· Gilbert, AZMayo Clinic Hospital· Phoenix, AZRegeneron Study Site· Tucson, AZThe Angeles Clinic· Los Angeles, CAUniversity of Southern California (USC)· Los Angeles, CAStanford Cancer Institute, Stanford Medicine at Stanford University· Palo Alto, CA

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