Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

A Phase 2 Peri-Operative Study of Treatment With Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Patients With Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).

The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.

The study is looking at several other research questions, including:

• Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery
• Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery
• What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab
• How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times
• Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)

Study Overview

• Status: Withdrawn
• Conditions: Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Drug: cemiplimab; Drug: fianlimab

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice
2. Tumor biopsy is required during screening period as described in the protocol
3. Participant is willing to undergo delayed surgery
4. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate organ and bone marrow function as described in the protocol

Key Exclusion Criteria:

1. Stage I or II CSCC
2. Anogenital, penile, vermilion lip CSCC
3. CSCC bone invasion
4. Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol
5. Prior radiation therapy for CSCC
6. Myocardial infarction within 6 months of enrollment, or history of myocarditis.
7. Prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol

Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cemiplimab	Drug: cemiplimab; Administered Intravenous (IV) infusion every three weeks (Q3W); Other Names: REGN2810; Libtayo
Experimental: fianlimab+cemiplimab	Drug: cemiplimab; Administered Intravenous (IV) infusion every three weeks (Q3W); Other Names: REGN2810; Libtayo; Drug: fianlimab; IV infusion Q3W; Other Names: REGN3767

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)	Up to 100 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)		Up to 3 years
pCR rate by local pathological review		Up to 100 days
Major pathological response (MPR)		Up to 100 days
Event-free survival (EFS)		Up to 3 years
Disease free survival (DFS)		Up to 3 years
Objective response rate (ORR) prior to surgery		Up to 100 days
Occurrence of treatment-emergent adverse events (TEAEs)		Up to 3 years
Occurrence of immune-mediated adverse events (imAEs)		Up to 3 years
Occurrence of treatment-related TEAEs		Up to 3 years
Occurrence of adverse event of special interest (AESI)		Up to 3 years
Occurrence of treatment-emergent serious adverse events (SAEs)		Up to 3 years
Occurrence of laboratory abnormalities	Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0	Up to 3 years
Occurrence of death due to TEAE		Up to 3 years
Occurrence of interruption of study drug(s) due to TEAEs		Up to 3 years
Occurrence of discontinuation of study drug(s) due to TEAEs		Up to 3 years
Occurrence of cancellation of surgery due to TEAE		Up to 100 days
Occurrence of delay to surgery due to TEAE		Up to 100 days
Concentrations of cemiplimab in serum		Up to 3 years
Concentrations of fianlimab in serum		Up to 3 years
Concentrations of other experimental agents (as applicable) in serum		Up to 3 years
Incidence of anti-drug antibodies (ADA) to cemiplimab		Up to 3 years
Incidence of ADA to fianlimab		Up to 3 years
Incidence of ADA to other experimental agents (as applicable)		Up to 3 years
Titer of ADA to cemiplimab		Up to 3 years
Titer of ADA to fianlimab		Up to 3 years
Titer of ADA to other experimental agents (as applicable)		Up to 3 years

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): November 14, 2024
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): May 6, 2030

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 25, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Neoadjuvant; Adjuvant
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R3767-ONC-2330; 2023-510514-38-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• IPD Sharing Time Frame: 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 made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• IPD Sharing Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes