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CemiplimAb Survivorship Epidemiology (CASE)

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ClinicalTrials.gov Identifier: NCT03836105
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : April 26, 2022
Sponsor:
Information provided by (Responsible Party):
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 cutaneous squamous cell carcinoma (CSCC) and patients with advanced 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 HHI usage

Condition or disease Intervention/treatment
Cutaneous Squamous Cell Carcinoma Basal Cell Carcinoma Drug: cemiplimab

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cemiplimab Survivorship Epidemiology (CASE) Study
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

Intervention Details:
  • 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


Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 CSCC or BCC in a real-world setting.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836105


Contacts
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Contact: Medical Affairs 844-734-6643 clinicaltrials@regeneron.com

Locations
Show Show 51 study locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceutical, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03836105    
Other Study ID Numbers: R2810-ONC-1806
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: April 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
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.
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).
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Advanced CSCC
Advanced BCC
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents