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

Sponsor

Regeneron Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04154943

Collaborator

Sanofi (Industry)

Enrollment

Locations

Arm

65.9

Anticipated Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cutaneous Squamous Cell Carcinoma	Drug: Cemiplimab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

80 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 :

Mar 10, 2020

Actual Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Sep 5, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cemiplimab Will receive IV infusion Q3W	Drug: Cemiplimab Intravenous (IV) infusion every 3 weeks (Q3W) Other Names: REGN2810 Libtayo

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

Primary Outcome Measures

Pathologic complete response (pCR) rate assessed by independent central pathology review [Up to 12 weeks]

Secondary Outcome Measures

Major pathologic response (mPR) rate assessed by independent central pathology review [Up to 12 weeks]
pCR rate assessed by local pathology review [Up to 12 weeks]
mPR rate assessed by local pathology review [Up to 12 weeks]
Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1 [Up to 12 weeks]
Event free survival (EFS) [Up to 50 months]
Disease free survival (DFS) [Up to 47 months]
Overall survival (OS) [Up to 50 months]
Incidence of adverse events (AEs) [Up to 52 months]
Incidence of serious adverse events (SAEs) [Up to 52 months]
Incidence of deaths [Up to 52 months]
Incidence of laboratory abnormalities [Up to 52 months]
Change in surgical plan in the screening period versus actual surgery after neoadjuvant cemiplimab [Up to 12 weeks]
Change in post-surgical management plan in the screening period versus actual post-surgical management [Up to 14 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Regeneron Study Site	Palo Alto	California	United States	94304
2	Regeneron Study Site	Washington	District of Columbia	United States	20037
3	Regeneron Study Site	Miami	Florida	United States	33176
4	Regeneron Study Site	Tampa	Florida	United States	33612
5	Regeneron Study Site	Baltimore	Maryland	United States	21231
6	Regeneron Study Site	Boston	Massachusetts	United States	02114
7	Regeneron Study Site	Boston	Massachusetts	United States	02215
8	Regeneron Study Site	Ann Arbor	Michigan	United States	48109
9	Regeneron Study Site	Omaha	Nebraska	United States	68114
10	Regeneron Study Site	New York	New York	United States	10065
11	Regeneron Study Site	Charlotte	North Carolina	United States	28204
12	Regeneron Study Site	Durham	North Carolina	United States	27710
13	Regeneron Study Site	Cleveland	Ohio	United States	44195
14	Regeneron Study Site	Dallas	Texas	United States	75390
15	Regeneron Study Site	Houston	Texas	United States	77030
16	Regeneron Study Site	St Leonards	New South Wales	Australia	2065
17	Regeneron Study Site	Herston	Queensland	Australia	4029
18	Regeneron Study Site	Melbourne	Victoria	Australia	3000
19	Regeneron Study Site	Dresden		Germany	01307
20	Regeneron Study Site	Essen		Germany	45147
21	Regeneron Study Site	Kiel		Germany	24105
22	Regeneron Study Site	Tübingen		Germany	72076