CemiplimAb Survivorship Epidemiology

Basal Cell Carcinoma Clinical Trial

— CASE  

Official title:

Cemiplimab Survivorship Epidemiology (CASE) Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03836105
• Other study ID #: R2810-ONC-1806
• Status: Active, not recruiting
• Start date: June 27, 2019
• Est. completion date: October 28, 2025

Study information

• Verified date: October 2023
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 287
• Est. completion date: October 28, 2025
• Est. primary completion date: October 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

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

Key Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell
• Cutaneous Squamous Cell Carcinoma

Intervention

Drug:
• cemiplimab
No investigational agents will be provided to enrolled patients by the sponsor as part of this study. Patients will have recently initiated or be planning to initiate treatment with commercially available cemiplimab for advanced CSCC or advanced BCC in a real-world setting according to respective label indications. In addition to cemiplimab, patients may receive other therapies as deemed necessary by their physicians for the treatment of CSCC or BCC or comorbid conditions.

Locations

Country	Name	City	State
Puerto Rico	Pan-American Center for Oncology Trials, LLC	Rio Piedras
Puerto Rico	FDI Clinical Research	San Juan
United States	Texas Oncology-Amarillo Cancer Center	Amarillo	Texas
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	Baltimore Veterans Affairs Medical Center	Baltimore	Maryland
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Montefiore Hospital	Bronx	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Lahey Hospital & Medical Center	Burlington	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Charleston Hematology Oncology Associates, PA	Charleston	South Carolina
United States	Clinical Research Center of the Carolinas	Charleston	South Carolina
United States	Oncology Specialists of Charlotte, PA	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Texas Oncology	Dallas	Texas
United States	University of Texas Southwestern	Dallas	Texas
United States	Integrity Clinical Research	Delray Beach	Florida
United States	Durham VA Medical Center	Durham	North Carolina
United States	Regeneron Research Facility	Elizabeth	New Jersey
United States	The Melanoma and Skin Cancer Institute	Englewood	Colorado
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Frederick Health	Frederick	Maryland
United States	MD Anderson Cancer Center	Houston	Texas
United States	Oncology Specialties, PC - Clearview Cancer Institute	Huntsville	Alabama
United States	Mayo Clinic	Jacksonville	Florida
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	University of California San Diego	La Jolla	California
United States	Regeneron Research Facility	Largo	Florida
United States	Optum Cancer Care	Las Vegas	Nevada
United States	Southeast Nebraska Hematology & Oncology Consultants, PC	Lincoln	Nebraska
United States	CARTI Cancer Center	Little Rock	Arkansas
United States	Harbor-UCLA/LA Biomedical Research Institute	Los Angeles	California
United States	Regional Cancer Care Associates, LLC	Manchester	Connecticut
United States	Asante Rogue Regional Medical Center	Medford	Oregon
United States	Miami Cancer Institute at Baptist Health, Inc.	Miami	Florida
United States	Regeneron Research Facility	Miami	Florida
United States	Regeneron Research Facility	New York	New York
United States	Regeneron Research Facility	New York	New York
United States	Regeneron Research Facility	Nyack	New York
United States	Dignity Health St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	New York Cancer and Blood Specialists	Port Jefferson Station	New York
United States	Oregon Health & Science University	Portland	Oregon
United States	Reid Oncology Association	Richmond	Indiana
United States	St. Mary's Medical Center	San Francisco	California
United States	CHRISTUS Highland Cancer Treatment Center	Shreveport	Louisiana
United States	Regeneron Research Facility	Stanford	California
United States	Moffitt Cancer Center	Tampa	Florida
United States	Renovatio Clinical	The Woodlands	Texas
United States	Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital	Thomasville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)	The rate of complete responses (CR) or partial responses (PR), as assessed by investigators	Up to 36 months
Primary	Disease control rate (DCR)	Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators	Up to 36 months
Primary	Duration of response (DOR)	Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment	Up to 36 months
Primary	Time to response	Time from date of first admission of cemiplimab to the initial response	Up to 36 months
Primary	Progression free survival (PFS)	Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first	Up to 36 months
Primary	Overall Survival (OS)	Time from the date of first administration of cemiplimab to the date of death due to any cause	Up to 36 months
Primary	Time to treatment failure (TTTF)	Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death	Up to 36 months
Primary	Disease specific death (DSD)	Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators	Up to 36 months
Primary	Number of patients with metastatic vs locally advanced cancer summarized every three weeks	Pattern of recurrence	Up to 36 months
Primary	Immune related adverse events (irAEs)	Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5	Up to 36 months
Primary	Infusion related reactions (IRRs)	NCI-CTCAE v5	Up to 36 months
Primary	Treatment related serious adverse reactions (SARs)		Up to 36 months