CemiplimAb Survivorship Epidemiology

Active, not recruiting

• Conditions: Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinoma
• Interventions: Drug: cemiplimab

• Registration Number: NCT03836105
• Lead Sponsor: Regeneron Pharmaceuticals

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-07
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Study Start: 2019-06-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-30
• Primary Completion: 2025-10-28
• Study Completion: 2025-10-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 287

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	cemiplimab	This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) CSCC.
Group 2	cemiplimab	This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) BCC.

Primary Outcome Measures

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

Trial Locations

Locations (47)

Lahey Hospital & Medical Center; 🇺🇸 Burlington, Massachusetts, United States

Harbor-UCLA/LA Biomedical Research Institute; 🇺🇸 Los Angeles, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Miami Cancer Institute at Baptist Health, Inc.; 🇺🇸 Miami, Florida, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Optum Cancer Care; 🇺🇸 Las Vegas, Nevada, United States

Regional Cancer Care Associates, LLC; 🇺🇸 Manchester, Connecticut, United States

Integrity Clinical Research; 🇺🇸 Delray Beach, Florida, United States

Texas Oncology-Amarillo Cancer Center; 🇺🇸 Amarillo, Texas, United States

Pan-American Center for Oncology Trials, LLC; 🇵🇷 Rio Piedras, Puerto Rico

Dignity Health St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

St. Mary's Medical Center; 🇺🇸 San Francisco, California, United States

Durham VA Medical Center; 🇺🇸 Durham, North Carolina, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

CARTI Cancer Center; 🇺🇸 Little Rock, Arkansas, United States

Regeneron Research Facility; 🇺🇸 Nyack, New York, United States

The Melanoma and Skin Cancer Institute; 🇺🇸 Englewood, Colorado, United States

Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital; 🇺🇸 Thomasville, Georgia, United States

NorthShore University HealthSystem; 🇺🇸 Evanston, Illinois, United States

Baltimore Veterans Affairs Medical Center; 🇺🇸 Baltimore, Maryland, United States

CHRISTUS Highland Cancer Treatment Center; 🇺🇸 Shreveport, Louisiana, United States

Reid Oncology Association; 🇺🇸 Richmond, Indiana, United States

Frederick Health; 🇺🇸 Frederick, Maryland, United States

Southeast Nebraska Hematology & Oncology Consultants, PC; 🇺🇸 Lincoln, Nebraska, United States

Montefiore Hospital; 🇺🇸 Bronx, New York, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

New York Cancer and Blood Specialists; 🇺🇸 Port Jefferson Station, New York, United States

Oncology Specialists of Charlotte, PA; 🇺🇸 Charlotte, North Carolina, United States

Asante Rogue Regional Medical Center; 🇺🇸 Medford, Oregon, United States

St. Luke's University Health Network; 🇺🇸 Bethlehem, Pennsylvania, United States

Texas Oncology; 🇺🇸 Dallas, Texas, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

Renovatio Clinical; 🇺🇸 The Woodlands, Texas, United States

FDI Clinical Research; 🇵🇷 San Juan, Puerto Rico

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Inova Schar Cancer Institute; 🇺🇸 Fairfax, Virginia, United States

Oncology Specialties, PC - Clearview Cancer Institute; 🇺🇸 Huntsville, Alabama, United States

University of Tennessee Medical Center; 🇺🇸 Knoxville, Tennessee, United States

University of California San Diego; 🇺🇸 La Jolla, California, United States

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Clinical Research Center of the Carolinas; 🇺🇸 Charleston, South Carolina, United States

Charleston Hematology Oncology Associates, PA; 🇺🇸 Charleston, South Carolina, United States