Skip to main content
OpenTrials
Completed

NCT Number: NCT04154943

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cutaneous Squamous Cell Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Regeneron Study Site, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Key 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

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

Treatment and study plan

cemiplimab

Drug

Intravenous (IV) infusion every 3 weeks (Q3W)

Other names: REGN2810, Libtayo

Primary outcomes

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

    Time frame: Up to 12 weeks

Secondary outcomes

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

    Time frame: Up to 12 Weeks

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

    Time frame: Up to 12 weeks

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

    Time frame: Up to 12 Weeks

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

    Time frame: Up to 12 Weeks

  5. Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab

    Time frame: Up to 12 Weeks

  6. Number of Participants With Planned and Actual Post-Surgical Management

    Time frame: Up to 14 Weeks

  7. Event Free Survival (EFS)

    Time frame: Up to 50 Months

  8. Disease Free Survival (DFS)

    Time frame: Up to 47 Months

  9. Overall Survival (OS)

    Time frame: Up to 50 Months

  10. Incidence of Adverse Events (AEs)

    Time frame: Up to 52 Months

  11. Incidence of Serious Adverse Events (SAEs)

    Time frame: Up to 52 Months

  12. Incidence of Deaths

    Time frame: Up to 52 Months

  13. Incidence of Laboratory Abnormalities

    Time frame: Up to 52 Months

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Collaborators

  • Sanofi

Registry information

Official study title

A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

Important dates

Study start
2020
Primary completion
2021
Study completion
2025
First posted
Nov 7, 2019
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.