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

Cutaneous Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04154943
• Other study ID #: R2810-ONC-1901
• Secondary ID: 2019-003007-3520
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 10, 2020
• Est. completion date: September 5, 2025

Study information

• Verified date: January 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 79
• Est. completion date: September 5, 2025
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Cutaneous Squamous Cell Carcinoma

Intervention

Drug:
• Cemiplimab
Intravenous (IV) infusion every 3 weeks (Q3W)

Locations

Country	Name	City	State
Australia	Regeneron Study Site	Herston	Queensland
Australia	Regeneron Study Site	Melbourne	Victoria
Australia	Regeneron Study Site	St Leonards	New South Wales
Germany	Regeneron Study Site	Dresden
Germany	Regeneron Study Site	Essen
Germany	Regeneron Study Site	Kiel
Germany	Regeneron Study Site	Tübingen
United States	Regeneron Study Site	Ann Arbor	Michigan
United States	Regeneron Study Site	Baltimore	Maryland
United States	Regeneron Study Site	Boston	Massachusetts
United States	Regeneron Study Site	Boston	Massachusetts
United States	Regeneron Study Site	Charlotte	North Carolina
United States	Regeneron Study Site	Cleveland	Ohio
United States	Regeneron Study Site	Dallas	Texas
United States	Regeneron Study Site	Durham	North Carolina
United States	Regeneron Study Site	Houston	Texas
United States	Regeneron Study Site	Miami	Florida
United States	Regeneron Study Site	New York	New York
United States	Regeneron Study Site	Omaha	Nebraska
United States	Regeneron Study Site	Palo Alto	California
United States	Regeneron Study Site	Tampa	Florida
United States	Regeneron Study Site	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review		Up to 12 weeks
Secondary	Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review		Up to 12 Weeks
Secondary	Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review		Up to 12 weeks
Secondary	Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review		Up to 12 Weeks
Secondary	Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1		Up to 12 Weeks
Secondary	Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab		Up to 12 Weeks
Secondary	Number of Participants With Planned and Actual Post-Surgical Management		Up to 14 Weeks
Secondary	Event Free Survival (EFS)		Up to 50 Months
Secondary	Disease Free Survival (DFS)		Up to 47 Months
Secondary	Overall Survival (OS)		Up to 50 Months
Secondary	Incidence of Adverse Events (AEs)		Up to 52 Months
Secondary	Incidence of Serious Adverse Events (SAEs)		Up to 52 Months
Secondary	Incidence of Deaths		Up to 52 Months
Secondary	Incidence of Laboratory Abnormalities		Up to 52 Months