NCT04154943

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2020

Longer than P75 for phase_2

Geographic Reach
3 countries

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

March 10, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 8, 2023

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

November 5, 2019

Results QC Date

November 30, 2022

Last Update Submit

December 4, 2025

Conditions

Cutaneous Squamous Cell Carcinoma

Keywords

CSCCStage IIStage IIIStage IVCSCC of Head/neckCSCC of ExtremityCSCC of Trunk

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review

    Up to 12 weeks

Secondary Outcomes (13)

  • Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review

    Up to 12 Weeks

  • Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review

    Up to 12 weeks

  • Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review

    Up to 12 Weeks

  • Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1

    Up to 12 Weeks

  • Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab

    Up to 12 Weeks

  • +8 more secondary outcomes

Study Arms (1)

Cemiplimab

EXPERIMENTAL

Will receive IV infusion Q3W

Drug: Cemiplimab

Interventions

CemiplimabDRUG

Intravenous (IV) infusion every 3 weeks (Q3W)

Also known as: REGN2810, Libtayo
Cemiplimab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Regeneron Study Site

Palo Alto, California, 94304, United States

Location

Regeneron Study Site

Washington D.C., District of Columbia, 20037, United States

Location

Regeneron Study Site

Miami, Florida, 33176, United States

Location

Regeneron Study Site

Tampa, Florida, 33612, United States

Location

Regeneron Study Site

Baltimore, Maryland, 21231, United States

Location

Regeneron Study Site

Boston, Massachusetts, 02114, United States

Location

Regeneron Study Site

Boston, Massachusetts, 02215, United States

Location

Regeneron Study Site

Ann Arbor, Michigan, 48109, United States

Location

Regeneron Study Site

Omaha, Nebraska, 68114, United States

Location

Regeneron Study Site

New York, New York, 10065, United States

Location

Regeneron Study Site

Charlotte, North Carolina, 28204, United States

Location

Regeneron Study Site

Durham, North Carolina, 27710, United States

Location

Regeneron Study Site

Cleveland, Ohio, 44195, United States

Location

Regeneron Study Site

Dallas, Texas, 75390, United States

Location

Regeneron Study Site

Houston, Texas, 77030, United States

Location

Regeneron Study Site

St Leonards, New South Wales, 2065, Australia

Location

Regeneron Study Site

Herston, Queensland, 4029, Australia

Location

Regeneron Study Site

Melbourne, Victoria, 3000, Australia

Location

Regeneron Study Site

Dresden, 01307, Germany

Location

Regeneron Study Site

Essen, 45147, Germany

Location

Regeneron Study Site

Kiel, 24105, Germany

Location

Regeneron Study Site

Tübingen, 72076, Germany

Location

Related Publications (2)

  • 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.

    PMID: 37875144DERIVED

  • 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.

    PMID: 36094839DERIVED

MeSH Terms

Interventions

cemiplimab

Results Point of Contact

Title
Clinical Trials Administrator
Organization
Regeneron Pharmaceuticals, Inc.
clinicaltrials@regeneron.com
844-734-6643

Study Officials

  • Clinical Trial Management

    Regeneron Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 7, 2019

Study Start

March 10, 2020

Primary Completion

December 1, 2021

Study Completion

November 19, 2025

Last Updated

December 23, 2025

Results First Posted

February 8, 2023

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
More information

Locations

US(15)AU(3)DE(4)