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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
Results First Posted : February 8, 2023
Last Update Posted : February 8, 2023
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Study Description
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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

Condition or disease Intervention/treatment Phase
Cutaneous Squamous Cell Carcinoma Drug: Cemiplimab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
Actual Study Start Date : March 10, 2020
Actual Primary Completion Date : December 1, 2021
Estimated Study Completion Date : September 5, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cemiplimab
Will receive IV infusion Q3W
 Drug: Cemiplimab
Intravenous (IV) infusion every 3 weeks (Q3W)
Other Names:
  • REGN2810
  • Libtayo


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04154943


Locations
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United States, California
Regeneron Study Site
Palo Alto, California, United States, 94304
United States, District of Columbia
Regeneron Study Site
Washington, District of Columbia, United States, 20037
United States, Florida
Regeneron Study Site
Miami, Florida, United States, 33176
Regeneron Study Site
Tampa, Florida, United States, 33612
United States, Maryland
Regeneron Study Site
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Regeneron Study Site
Boston, Massachusetts, United States, 02114
Regeneron Study Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Regeneron Study Site
Ann Arbor, Michigan, United States, 48109
United States, Nebraska
Regeneron Study Site
Omaha, Nebraska, United States, 68114
United States, New York
Regeneron Study Site
New York, New York, United States, 10065
United States, North Carolina
Regeneron Study Site
Charlotte, North Carolina, United States, 28204
Regeneron Study Site
Durham, North Carolina, United States, 27710
United States, Ohio
Regeneron Study Site
Cleveland, Ohio, United States, 44195
United States, Texas
Regeneron Study Site
Dallas, Texas, United States, 75390
Regeneron Study Site
Houston, Texas, United States, 77030
Australia, New South Wales
Regeneron Study Site
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Regeneron Study Site
Herston, Queensland, Australia, 4029
Australia, Victoria
Regeneron Study Site
Melbourne, Victoria, Australia, 3000
Germany
Regeneron Study Site
Dresden, Germany, 01307
Regeneron Study Site
Essen, Germany, 45147
Regeneron Study Site
Kiel, Germany, 24105
Regeneron Study Site
Tübingen, Germany, 72076
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Regeneron Pharmaceuticals:
Study Protocol  [PDF] July 16, 2019
Statistical Analysis Plan  [PDF] August 10, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04154943    
Other Study ID Numbers: R2810-ONC-1901
2019-003007-35 ( EudraCT Number )
2022-500811-37-00 ( Other Identifier: EU CTR-CTIS )
First Posted: November 7, 2019    Key Record Dates
Results First Posted: February 8, 2023
Last Update Posted: February 8, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
CSCC
Stage II
Stage III
Stage IV
 CSCC of Head/neck
CSCC of Extremity
CSCC of Trunk
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents