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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04154943
Recruitment Status : Active, not recruiting
First Posted : November 7, 2019
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 5, 2019
First Posted Date  ICMJE November 7, 2019
Last Update Posted Date April 6, 2022
Actual Study Start Date  ICMJE March 10, 2020
Actual Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
Pathologic complete response (pCR) rate assessed by independent central pathology review [ Time Frame: Up to 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2019)
  • Major pathologic response (mPR) rate assessed by independent central pathology review [ Time Frame: Up to 12 weeks ]
  • pCR rate assessed by local pathology review [ Time Frame: Up to 12 weeks ]
  • mPR rate assessed by local pathology review [ Time Frame: Up to 12 weeks ]
  • Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1 [ Time Frame: Up to 12 weeks ]
  • Event free survival (EFS) [ Time Frame: Up to 50 months ]
  • Disease free survival (DFS) [ Time Frame: Up to 47 months ]
  • Overall survival (OS) [ Time Frame: Up to 50 months ]
  • Incidence of adverse events (AEs) [ Time Frame: Up to 52 months ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: Up to 52 months ]
  • Incidence of deaths [ Time Frame: Up to 52 months ]
  • Incidence of laboratory abnormalities [ Time Frame: Up to 52 months ]
  • Change in surgical plan in the screening period versus actual surgery after neoadjuvant cemiplimab [ Time Frame: Up to 12 weeks ]
  • Change in post-surgical management plan in the screening period versus actual post-surgical management [ Time Frame: Up to 14 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
Official Title  ICMJE A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Squamous Cell Carcinoma
Intervention  ICMJE Drug: Cemiplimab
Intravenous (IV) infusion every 3 weeks (Q3W)
Other Names:
  • REGN2810
  • Libtayo
Study Arms  ICMJE Experimental: Cemiplimab
Will receive IV infusion Q3W
Intervention: Drug: Cemiplimab
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 25, 2021)
80
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2019)
76
Estimated Study Completion Date  ICMJE September 5, 2025
Actual Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04154943
Other Study ID Numbers  ICMJE R2810-ONC-1901
2019-003007-35 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data 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, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/
Current Responsible Party Regeneron Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Regeneron Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Sanofi
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP