COMPLETED

Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC). The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810). The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks. The study is also looking at several other research questions, including: * What side effects may happen from taking the study drug * To see effect of cemiplimab on the tumor * How much study drug is in the blood at different times

Official Title

A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)

Quick Facts

Study Start:2019-04-11
Study Completion:2025-12-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03889912

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Medical Dermatology Specialists
Phoenix, Arizona, 85006
United States
TCR Medical Corporation
San Diego, California, 92123
United States
Dermatology Associates of the Palm Beaches
Delray Beach, Florida, 33445
United States
MetroDerm
Atlanta, Georgia, 30342
United States
Northeast Dermatology Associates
Beverly, Massachusetts, 01915
United States
Rochester Dermatologic Surgery, P.C.
Victor, New York, 14564
United States
Duke Cancer Center
Durham, North Carolina, 27710
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-11
Study Completion Date2025-12-10

Study Record Updates

Study Start Date2019-04-11
Study Completion Date2025-12-10

Terms related to this study

Keywords Provided by Researchers

  • CSCC
  • BCC

Additional Relevant MeSH Terms

  • Cutaneous Squamous Cell Carcinoma
  • Basal Cell Carcinoma