Clinical trial NCT03836105: CemiplimAb Survivorship Epidemiology
Official title: Cemiplimab Survivorship Epidemiology (CASE) Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cutaneous Squamous Cell Carcinoma
Basal Cell Carcinoma
Keywords: Locally Advanced CSCC (laCSCC)
Metastatic CSCC (mCSCC)
Locally Advanced BCC (laBCC)
Metastatic BCC (mBCC)
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-02-11
Enrollment: 287
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to 36 months
measure: Disease control rate (DCR)
timeFrame: Up to 36 months
measure: Duration of response (DOR)
timeFrame: Up to 36 months
measure: Time to response
timeFrame: Up to 36 months
measure: Progression free survival (PFS)
timeFrame: Up to 36 months
measure: Overall Survival (OS)
timeFrame: Up to 36 months
measure: Time to treatment failure (TTTF)
timeFrame: Up to 36 months
measure: Disease specific death (DSD)
timeFrame: Up to 36 months
measure: Number of patients with metastatic vs locally advanced cancer summarized every three weeks
timeFrame: Up to 36 months
measure: Immune related adverse events (irAEs)
timeFrame: Up to 36 months
measure: Infusion related reactions (IRRs)
timeFrame: Up to 36 months
measure: Treatment related serious adverse reactions (SARs)
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Oncology Specialties, PC - Clearview Cancer Institute
state: Alabama
city: Phoenix
country: United States
facility: Dignity Health St. Joseph's Hospital and Medical Center
state: Arizona
city: Little Rock
country: United States
facility: CARTI Cancer Center
state: Arkansas
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Los Angeles
country: United States
facility: Harbor-UCLA/LA Biomedical Research Institute
state: California
city: San Francisco
country: United States
facility: St. Mary's Medical Center
state: California
city: Stanford
country: United States
facility: Regeneron Research Facility
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Englewood
country: United States
facility: The Melanoma and Skin Cancer Institute
state: Colorado
city: Manchester
country: United States
facility: Regional Cancer Care Associates, LLC
state: Connecticut
city: Delray Beach
country: United States
facility: Integrity Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Largo
country: United States
facility: Regeneron Research Facility
state: Florida
city: Miami
country: United States
facility: Regeneron Research Facility
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute at Baptist Health, Inc.
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Thomasville
country: United States
facility: Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Richmond
country: United States
facility: Reid Oncology Association
state: Indiana
city: Shreveport
country: United States
facility: CHRISTUS Highland Cancer Treatment Center
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore Veterans Affairs Medical Center
state: Maryland
city: Frederick
country: United States
facility: Frederick Health
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital & Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Lincoln
country: United States
facility: Southeast Nebraska Hematology & Oncology Consultants, PC
state: Nebraska
city: Las Vegas
country: United States
facility: Optum Cancer Care
state: Nevada
city: Elizabeth
country: United States
facility: Regeneron Research Facility
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Hospital
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Regeneron Research Facility
state: New York
city: New York
country: United States
facility: Regeneron Research Facility
state: New York
city: Nyack
country: United States
facility: Regeneron Research Facility
state: New York
city: Port Jefferson Station
country: United States
facility: New York Cancer and Blood Specialists
state: New York
city: Charlotte
country: United States
facility: Oncology Specialists of Charlotte, PA
state: North Carolina
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
city: Medford
country: United States
facility: Asante Rogue Regional Medical Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates, PA
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Amarillo
country: United States
facility: Texas Oncology-Amarillo Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: Renovatio Clinical
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Rio Piedras
country: Puerto Rico
facility: Pan-American Center for Oncology Trials, LLC
city: San Juan
country: Puerto Rico
facility: FDI Clinical Research
Study officials:
affiliation: Regeneron Pharmaceutical, Inc.
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: 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.