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

NCT ID: NCT04154943

Last Updated: 2025-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-10

Study Completion Date

2025-11-19

Brief Summary

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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

Detailed Description

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Conditions

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Cutaneous Squamous Cell Carcinoma

Keywords

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CSCC Stage II Stage III Stage IV CSCC of Head/neck CSCC of Extremity CSCC of Trunk

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cemiplimab

Will receive IV infusion Q3W

Group Type EXPERIMENTAL

Cemiplimab

Intervention Type DRUG

Intravenous (IV) infusion every 3 weeks (Q3W)

Interventions

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Cemiplimab

Intravenous (IV) infusion every 3 weeks (Q3W)

Intervention Type DRUG

Other Intervention Names

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REGN2810 Libtayo

Eligibility Criteria

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Inclusion Criteria

* Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
* At least 1 lesion that is measurable by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ, bone marrow function, and hepatic function as defined in the protocol

Exclusion Criteria

* Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia \[CLL\]) at any time
* Distant metastatic disease (M1), visceral and/or distant nodal
* Prior radiation therapy for CSCC
* Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
* Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
* History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
* Active tuberculosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Study Site

Palo Alto, California, United States

Site Status

Regeneron Study Site

Washington D.C., District of Columbia, United States

Site Status

Regeneron Study Site

Miami, Florida, United States

Site Status

Regeneron Study Site

Tampa, Florida, United States

Site Status

Regeneron Study Site

Baltimore, Maryland, United States

Site Status

Regeneron Study Site

Boston, Massachusetts, United States

Site Status

Regeneron Study Site

Boston, Massachusetts, United States

Site Status

Regeneron Study Site

Ann Arbor, Michigan, United States

Site Status

Regeneron Study Site

Omaha, Nebraska, United States

Site Status

Regeneron Study Site

New York, New York, United States

Site Status

Regeneron Study Site

Charlotte, North Carolina, United States

Site Status

Regeneron Study Site

Durham, North Carolina, United States

Site Status

Regeneron Study Site

Cleveland, Ohio, United States

Site Status

Regeneron Study Site

Dallas, Texas, United States

Site Status

Regeneron Study Site

Houston, Texas, United States

Site Status

Regeneron Study Site

St Leonards, New South Wales, Australia

Site Status

Regeneron Study Site

Herston, Queensland, Australia

Site Status

Regeneron Study Site

Melbourne, Victoria, Australia

Site Status

Regeneron Study Site

Dresden, , Germany

Site Status

Regeneron Study Site

Essen, , Germany

Site Status

Regeneron Study Site

Kiel, , Germany

Site Status

Regeneron Study Site

Tübingen, , Germany

Site Status

Countries

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United States Australia Germany

References

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Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Yoo SY, Mathias M, Han H, Seebach F, Lowy I, Fury MG, Rischin D. Neoadjuvant cemiplimab and surgery for stage II-IV cutaneous squamous-cell carcinoma: follow-up and survival outcomes of a single-arm, multicentre, phase 2 study. Lancet Oncol. 2023 Nov;24(11):1196-1205. doi: 10.1016/S1470-2045(23)00459-X. Epub 2023 Oct 21.

Reference Type DERIVED
PMID: 37875144 (View on PubMed)

Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Kaufman HL, Seebach F, Lowy I, Yoo SY, Mathias M, Fenech K, Han H, Fury MG, Rischin D. Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2022 Oct 27;387(17):1557-1568. doi: 10.1056/NEJMoa2209813. Epub 2022 Sep 12.

Reference Type DERIVED
PMID: 36094839 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2019-003007-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2022-500811-37-00

Identifier Type: CTIS

Identifier Source: secondary_id

R2810-ONC-1901

Identifier Type: -

Identifier Source: org_study_id