CemiplimAb Survivorship Epidemiology (CASE)

Cemiplimab Survivorship Epidemiology (CASE) Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Basal Cell Carcinoma; Cutaneous Squamous Cell Carcinoma
• Intervention / Treatment: Drug: cemiplimab

• Study Type: Observational
• Enrollment (Actual): 287

Contacts and Locations

• Study Contact: Name: Medical Affairs; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• Puerto Rico
  • Rio Piedras, Puerto Rico, 00902
    • Pan-American Center for Oncology Trials, LLC
  • San Juan, Puerto Rico, 00927
    • FDI Clinical Research
• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Oncology Specialties, PC - Clearview Cancer Institute
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Dignity Health St. Joseph's Hospital and Medical Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • CARTI Cancer Center
  • California
    • La Jolla, California, United States, 92037
      • University of California San Diego
    • Los Angeles, California, United States, 90502
      • Harbor-UCLA/LA Biomedical Research Institute
    • San Francisco, California, United States, 94117
      • St. Mary's Medical Center
    • Stanford, California, United States, 94063
      • Regeneron Research Facility
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
    • Englewood, Colorado, United States, 80113
      • The Melanoma and Skin Cancer Institute
  • Connecticut
    • Manchester, Connecticut, United States, 06040
      • Regional Cancer Care Associates, LLC
  • Florida
    • Delray Beach, Florida, United States, 33745
      • Integrity Clinical Research
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Largo, Florida, United States, 33770
      • Regeneron Research Facility
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute at Baptist Health, Inc.
    • Miami, Florida, United States, 33156
      • Regeneron Research Facility
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Georgia
    • Thomasville, Georgia, United States, 31792
      • Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Evanston, Illinois, United States, 60201
      • NorthShore University Healthsystem
  • Indiana
    • Richmond, Indiana, United States, 47374
      • Reid Oncology Association
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Christus Highland Cancer Treatment Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore Veterans Affairs Medical Center
    • Frederick, Maryland, United States, 21702
      • Frederick Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital & Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Southeast Nebraska Hematology & Oncology Consultants, PC
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Optum Cancer Care
  • New Jersey
    • Elizabeth, New Jersey, United States, 07202
      • Regeneron Research Facility
  • New York
    • Bronx, New York, United States, 10461
      • Montefiore Hospital
    • Buffalo, New York, United States, 14203
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10016
      • Regeneron Research Facility
    • New York, New York, United States, 10032
      • Regeneron Research Facility
    • Nyack, New York, United States, 10960
      • Regeneron Research Facility
    • Port Jefferson Station, New York, United States, 11776
      • New York Cancer and Blood Specialists
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Oncology Specialists of Charlotte, PA
    • Durham, North Carolina, United States, 27705
      • Durham VA Medical Center
  • Oregon
    • Medford, Oregon, United States, 97504
      • Asante Rogue Regional Medical Center
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Health Network
  • South Carolina
    • Charleston, South Carolina, United States, 29414
      • Charleston Hematology Oncology Associates, PA
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • University of Tennessee Medical Center
  • Texas
    • Amarillo, Texas, United States, 79106
      • Texas Oncology-Amarillo Cancer Center
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Dallas, Texas, United States, 75246
      • Texas Oncology
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients in this study will include men and women ≥18 years of age who have recently initiated, or who plan to initiate treatment with commercially available cemiplimab for laCSCC/mCSCC or laBCC/mBCC in a real-world setting.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) CSCC.	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.; Other Names: REGN2810; Libtayo
Group 2; This group will enroll patients with advanced (defined as locally advanced or metastatic [nodal or distant]) BCC.	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.; Other Names: REGN2810; Libtayo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	The rate of complete responses (CR) or partial responses (PR), as assessed by investigators	Up to 36 months
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
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
Time to response	Time from date of first admission of cemiplimab to the initial response	Up to 36 months
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
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
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
Disease specific death (DSD)	Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators	Up to 36 months
Number of patients with metastatic vs locally advanced cancer summarized every three weeks	Pattern of recurrence	Up to 36 months
Immune related adverse events (irAEs)	Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5	Up to 36 months
Infusion related reactions (IRRs)	NCI-CTCAE v5	Up to 36 months
Treatment related serious adverse reactions (SARs)		Up to 36 months

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceutical, Inc.

Publications and helpful links

General Publications

• Migden MR, Chandra S, Rabinowits G, Chen CI, Desai J, Seluzhytsky A, Sasane M, Campanelli B, Chen Z, Freeman ML, Ibrahim SF, Khushalani NI, Andria M, Ruiz E. CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma. Future Oncol. 2020 Feb;16(4):11-19. doi: 10.2217/fon-2019-0762. Epub 2020 Jan 17.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Estimated): October 28, 2025
• Study Completion (Estimated): October 28, 2025

Study Registration Dates

• First Submitted: February 7, 2019
• First Submitted That Met QC Criteria: February 7, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Locally Advanced CSCC (laCSCC); Metastatic CSCC (mCSCC); Locally Advanced BCC (laBCC); Metastatic BCC (mBCC)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Basal Cell; Carcinoma; Carcinoma, Basal Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cemiplimab
• Other Study ID Numbers: R2810-ONC-1806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD that underlie publicly available results will be considered for sharing
• IPD Sharing Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• IPD Sharing Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No