NCT06384820

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)

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	cemiplimab	Administered Intravenous (IV) infusion every three weeks (Q3W)
DRUG	fianlimab	IV infusion Q3W

Timeline

• Start date: 2024-11-14
• Primary completion: 2026-06-08
• Completion: 2030-05-06
• First posted: 2024-04-25
• Last updated: 2024-07-26

Regulatory

• FDA-regulated drug study