Study on Cemiplimab Versus Placebo After Surgery and Radiation in Patients with High-Risk Skin Cancer

Sponsor: Regeneron Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03969004

Provider View

This clinical trial is testing whether the drug cemiplimab can help prevent high-risk cutaneous squamous cell carcinoma (CSCC) from returning after surgery and radiation therapy, compared to a placebo.

Patient Parameters

Program Overview

The main goal of this study is to see if cemiplimab can help stop high-risk cutaneous squamous cell carcinoma (CSCC) from coming back after surgery and radiation therapy. The study will also look at whether cemiplimab can help patients live longer and prevent the cancer from spreading to other areas. Additionally, the study will evaluate the safety of cemiplimab and how it behaves in the body.

Description

Cemiplimab is a type of medication called a monoclonal antibody, which is designed to help the immune system attack cancer cells. This study is for people who have had surgery and radiation for a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) and are at high risk of the cancer returning.

The study is divided into two parts:

  • Part 1: Participants will receive either cemiplimab or a placebo (a substance with no active medicine) through an IV drip every 3 weeks for 12 weeks, then every 6 weeks. This part includes a screening period (up to 28 days), a treatment period (about 48 weeks), a visit after treatment ends (about 30 days after treatment), and a follow-up period (up to 5 years or until the cancer returns or the study ends).

  • Part 2 (Optional): If the cancer returns and the participant was initially receiving a placebo, they may have the option to receive cemiplimab. This part includes a short screening period, a treatment period (about 96 weeks), and a visit after treatment ends (about 30 days after treatment).

The study will also monitor the safety of cemiplimab and how it interacts with the body.

Eligibility Criteria

Inclusion Criteria

  • For Japan only, men and women aged 21 years or older.
  • Patients who have had surgery to remove cutaneous squamous cell carcinoma (CSCC) and have completed radiation therapy.
  • Classified as high-risk CSCC according to the study's criteria.
  • Completed radiation therapy with the intent to cure within 2 to 10 weeks before joining the study.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Adequate liver, kidney, and bone marrow function as specified in the study.

Exclusion Criteria

  • Squamous cell carcinomas (SCCs) that occur in non-skin areas.
  • Other active cancers or a history of other cancers within the last 3 years, except for localized CSCC.
  • Blood cancers, except for chronic lymphocytic leukemia (CLL) if no treatment was needed in the last 6 months.
  • History of CSCC that spread to distant organs, unless cancer-free for at least 3 years.
  • Significant autoimmune diseases needing treatment in the last 5 years, except for certain conditions like vitiligo or type 1 diabetes.
  • Previous systemic anti-cancer immunotherapy for CSCC.

Note: Other specific criteria may apply.

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