Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

Part of paid clinical trials in Palo Alto, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04154943
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Cemiplimab — DRUG
    Intravenous (IV) infusion every 3 weeks (Q3W)

Study Details

The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review. The secondary objectives of the study are: * To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including: * Major pathologic response (mPR) rate per independent central pathology review * pCR rate and mPR rate per local pathology review * ORR prior to surgery, according to local assessment using RECIST 1.1 * To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS) * To evaluate the safety profile of neoadjuvant cemiplimab * To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review * To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review

Key Dates

Start date
Mar 10, 2020
Status verified
Dec 2025
Primary completion
Dec 1, 2021
Completion
Nov 19, 2025

Study Design

Enrollment
79 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cemiplimab
    Will receive IV infusion Q3W

Primary Outcome Measure

Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review [ Time Frame: Up to 12 weeks ]

Locations (15)

FacilityCityStateZIPSite coordinators
Regeneron Study SitePalo AltoCalifornia94304-
Regeneron Study SiteWashington D.C.District of Columbia20037-
Regeneron Study SiteMiamiFlorida33176-
Regeneron Study SiteTampaFlorida33612-
Regeneron Study SiteBaltimoreMaryland21231-
Regeneron Study SiteBostonMassachusetts02114-
Regeneron Study SiteBostonMassachusetts02215-
Regeneron Study SiteAnn ArborMichigan48109-
Regeneron Study SiteOmahaNebraska68114-
Regeneron Study SiteNew YorkNew York10065-
Regeneron Study SiteCharlotteNorth Carolina28204-
Regeneron Study SiteDurhamNorth Carolina27710-
Regeneron Study SiteClevelandOhio44195-
Regeneron Study SiteDallasTexas75390-
Regeneron Study SiteHoustonTexas77030-

Find similar trials in Palo Alto, CA

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Regeneron Study Site· Palo Alto, CARegeneron Study Site· Washington D.C., DCRegeneron Study Site· Miami, FLRegeneron Study Site· Tampa, FLRegeneron Study Site· Baltimore, MDRegeneron Study Site· Boston, MA

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