This study is in progress, not accepting new patients

CemiplimAb Survivorship Epidemiology

a study on Squamous Cell Carcinoma Basal Cell Carcinoma Carcinoma

Eligibility: for people ages 18 years and up (full criteria)
Location: at La Jolla, California and other locations
Dates: study started June 2019
completion around October 2025

Description

Summary

The objectives of the study are:

To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced (defined as locally advanced or metastatic [nodal or distant]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (defined as locally advanced or metastatic [nodal or distant]) basal cell carcinoma (BCC) in real-world clinical settings
To evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment related serious adverse reactions (TSARs) in patients with advanced CSCC and patients with advanced BCC receiving cemiplimab treatment in real world clinical settings
To describe patient experience, including patient reported quality of life (QOL) and functional status, and clinician reported performance status in a real-world setting for patients with advanced CSCC and patients with advanced BCC
To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced CSCC and patients with advanced BCC undergoing treatment with cemiplimab
To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world setting
To describe real-world use patterns of cemiplimab for CSCC and BCC
To investigate the long-term effects and effectiveness of cemiplimab in patients with advanced CSCC or advanced BCC
To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC or advanced BCC, regardless of etiology, per available data
To describe the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC per available data
To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with advanced CSCC, regardless of etiology, per available data
To describe the effectiveness of cemiplimab in patients with advanced BCC based on treatment patterns (reason for discontinuation, treatment exposure, etc) of prior Hedgehog inhibitor (HHI) usage

Official Title

Cemiplimab Survivorship Epidemiology (CASE) Study

Keywords

Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma, Locally Advanced CSCC (laCSCC), Metastatic CSCC (mCSCC), Locally Advanced BCC (laBCC), Metastatic BCC (mBCC), Carcinoma, Cemiplimab

Eligibility

You can join if…

Open to people ages 18 years and up

Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced BCC in accordance with approved prescribing information as described in the protocol

You CAN'T join if...

Receiving cemiplimab for an indication other than advanced CSCC or advanced BCC
Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study
Patients concurrently participating in any study including administration of any investigational drug (including cemiplimab) or procedure (including survival follow up)

Note: Other protocol defined Inclusion/Exclusion Criteria apply

Locations

University of California San Diego
La Jolla California 92037 United States
Harbor-UCLA/LA Biomedical Research Institute
Los Angeles California 90502 United States

Details

Status: in progress, not accepting new patients
Start Date: June 2019
Completion Date: October 2025 (estimated)
Sponsor: Regeneron Pharmaceuticals
ID: NCT03836105
Study Type: Observational
Participants: About 287 people participating
Last Updated: October 2023