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Completed

NCT Number: NCT03836105

CemiplimAb Survivorship Epidemiology

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

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Key information

Conditions

Cutaneous Squamous Cell Carcinoma Basal Cell Carcinoma Carcinoma Carcinoma, Basal Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: REGN2810, Libtayo

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 36 months

    The rate of complete responses (CR) or partial responses (PR), as assessed by investigators

  2. Disease control rate (DCR)

    Time frame: Up to 36 months

    Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators

  3. Duration of response (DOR)

    Time frame: 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

  4. Time to response

    Time frame: Up to 36 months

    Time from date of first admission of cemiplimab to the initial response

  5. Progression free survival (PFS)

    Time frame: Up to 36 months

    Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first

  6. Overall Survival (OS)

    Time frame: Up to 36 months

    Time from the date of first administration of cemiplimab to the date of death due to any cause

  7. Time to treatment failure (TTTF)

    Time frame: Up to 36 months

    Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death

  8. Disease specific death (DSD)

    Time frame: Up to 36 months

    Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators

  9. Number of patients with metastatic vs locally advanced cancer summarized every three weeks

    Time frame: Up to 36 months

    Pattern of recurrence

  10. Immune related adverse events (irAEs)

    Time frame: Up to 36 months

    Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5

  11. Infusion related reactions (IRRs)

    Time frame: Up to 36 months

    NCI-CTCAE v5

  12. Treatment related serious adverse reactions (SARs)

    Time frame: Up to 36 months

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

Cemiplimab Survivorship Epidemiology (CASE) Study

Acronym: CASE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2019
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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