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

Primary Purpose

Cutaneous Squamous Cell Carcinoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cemiplimab
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Squamous Cell Carcinoma focused on measuring CSCC, Stage II, Stage III, Stage IV, CSCC of Head/neck, CSCC of Extremity, CSCC of Trunk

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site
  • Regeneron Study Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cemiplimab

Arm Description

Will receive IV infusion Q3W

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Number of Participants With Planned and Actual Post-Surgical Management
Event Free Survival (EFS)
Disease Free Survival (DFS)
Overall Survival (OS)
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of Deaths
Incidence of Laboratory Abnormalities

Full Information

First Posted
November 5, 2019
Last Updated
January 11, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT04154943
Brief Title
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
Official Title
A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
September 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Squamous Cell Carcinoma
Keywords
CSCC, Stage II, Stage III, Stage IV, CSCC of Head/neck, CSCC of Extremity, CSCC of Trunk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cemiplimab
Arm Type
Experimental
Arm Description
Will receive IV infusion Q3W
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Intervention Description
Intravenous (IV) infusion every 3 weeks (Q3W)
Primary Outcome Measure Information:
Title
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
Time Frame
Up to 12 Weeks
Title
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
Time Frame
Up to 12 weeks
Title
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
Time Frame
Up to 12 Weeks
Title
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
Title
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Time Frame
Up to 12 Weeks
Title
Number of Participants With Planned and Actual Post-Surgical Management
Time Frame
Up to 14 Weeks
Title
Event Free Survival (EFS)
Time Frame
Up to 50 Months
Title
Disease Free Survival (DFS)
Time Frame
Up to 47 Months
Title
Overall Survival (OS)
Time Frame
Up to 50 Months
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to 52 Months
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to 52 Months
Title
Incidence of Deaths
Time Frame
Up to 52 Months
Title
Incidence of Laboratory Abnormalities
Time Frame
Up to 52 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Regeneron Study Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Regeneron Study Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Regeneron Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Regeneron Study Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Regeneron Study Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
Regeneron Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Regeneron Study Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Regeneron Study Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Regeneron Study Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Regeneron Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Regeneron Study Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Regeneron Study Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Regeneron Study Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Regeneron Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Regeneron Study Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Regeneron Study Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Regeneron Study Site
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Regeneron Study Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Regeneron Study Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Regeneron Study Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Regeneron Study Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Regeneron Study Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing 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.
IPD Sharing 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).
IPD Sharing URL
https://vivli.org/
Citations:
PubMed Identifier
36094839
Citation
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.
Results Reference
derived

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

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