CemiplimAb Survivorship Epidemiology

NCT03836105 | Completed FDA Drug

• 1 other identifier: R2810-ONC-1806
• Study Type: observational
• Target: 287
• Locations: 2 countries
• Sites: 53

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

Conditions

Cutaneous Squamous Cell Carcinoma; Basal Cell Carcinoma

Keywords

Locally Advanced CSCC (laCSCC); Metastatic CSCC (mCSCC); Locally Advanced BCC (laBCC); Metastatic BCC (mBCC)

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

Group 1

This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) CSCC.

Drug: cemiplimab

Group 2

This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) BCC.

Drug: cemiplimab

Interventions

cemiplimab DRUG

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.

Also known as: REGN2810, Libtayo

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 may not qualify 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)

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (53)

Oncology Specialties, PC - Clearview Cancer Institute

Huntsville, Alabama, 35805, United States

Location

Dignity Health St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

CARTI Cancer Center

Little Rock, Arkansas, 72205, United States

Location

University of California San Diego

La Jolla, California, 92037, United States

Location

Harbor-UCLA/LA Biomedical Research Institute

Los Angeles, California, 90502, United States

Location

St. Mary's Medical Center

San Francisco, California, 94117, United States

Location

Regeneron Research Facility

Stanford, California, 94063, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

The Melanoma and Skin Cancer Institute

Englewood, Colorado, 80113, United States

Location

Regional Cancer Care Associates, LLC

Manchester, Connecticut, 06040, United States

Location

Integrity Clinical Research

Delray Beach, Florida, 33745, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Regeneron Research Facility

Largo, Florida, 33770, United States

Location

Regeneron Research Facility

Miami, Florida, 33156, United States

Location

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, 33176, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital

Thomasville, Georgia, 31792, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

Reid Oncology Association

Richmond, Indiana, 47374, United States

Location

CHRISTUS Highland Cancer Treatment Center

Shreveport, Louisiana, 71105, United States

Location

Baltimore Veterans Affairs Medical Center

Baltimore, Maryland, 21201, United States

Location

Frederick Health

Frederick, Maryland, 21702, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Southeast Nebraska Hematology & Oncology Consultants, PC

Lincoln, Nebraska, 68510, United States

Location

Optum Cancer Care

Las Vegas, Nevada, 89102, United States

Location

Regeneron Research Facility

Elizabeth, New Jersey, 07202, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14203, United States

Location

Regeneron Research Facility

New York, New York, 10016, United States

Location

Regeneron Research Facility

New York, New York, 10032, United States

Location

Regeneron Research Facility

Nyack, New York, 10960, United States

Location

New York Cancer and Blood Specialists

Port Jefferson Station, New York, 11776, United States

Location

Montefiore Hospital

The Bronx, New York, 10461, United States

Location

Oncology Specialists of Charlotte, PA

Charlotte, North Carolina, 28204, United States

Location

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

Asante Rogue Regional Medical Center

Medford, Oregon, 97504, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

Charleston Hematology Oncology Associates, PA

Charleston, South Carolina, 29414, United States

Location

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

Location

Texas Oncology-Amarillo Cancer Center

Amarillo, Texas, 79106, United States

Location

Texas Oncology

Dallas, Texas, 75246, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Renovatio Clinical

The Woodlands, Texas, 77380, United States

Location

University of Vermont

Burlington, Vermont, 05401, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Pan-American Center for Oncology Trials, LLC

Rio Piedras, 00902, Puerto Rico

Location

FDI Clinical Research

San Juan, 00927, Puerto Rico

Location

Related Publications (2)

• Park SJ, Ellison DM, Weight R, Homsi J, Rabinowits G, Ruiz ES, Strasswimmer J, Simmons J, Panella T, Quek RG, Pouliot JF, Khushalani NI. CASE (CemiplimAb-rwlc Survivorship and Epidemiology): a study in advanced basal cell carcinoma. Future Oncol. 2025 Feb;21(4):431-436. doi: 10.1080/14796694.2024.2448416. Epub 2025 Jan 11.

  PMID: 39797702 DERIVED

• 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.

  PMID: 31951149 DERIVED

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

cemiplimab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceutical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 11, 2019
• Study Start: June 27, 2019
• Primary Completion: September 29, 2025
• Study Completion: September 29, 2025
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (51); PR (2)