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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 : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The objectives of the study are:

  • To identify potential determinants of disease progression, Quality of life (QOL), and other health-related outcomes for patients with Cutaneous squamous cell carcinoma (CSCC) undergoing treatment with cemiplimab
  • To assess patient experience, including QOL and functional status, in a real-world setting for patients with CSCC
  • To identify and describe long-term effects of treatment of patients with CSCC
  • To collect and describe serious adverse event (SAE) and immune-related adverse event (irAE) data on study participants
  • To describe patients who receive cemiplimab as treatment for CSCC in a real-world setting
  • To describe real-world use patterns of cemiplimab for CSCC
  • To assess the long-term effectiveness of cemiplimab in CSCC patients in a real-world setting
  • To assess the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with Advanced and metastatic cutaneous squamous cell carcinoma (aCSCC), regardless of etiology
  • To assess the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with a CSCC, regardless of etiology
  • To assess the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC

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

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Study Type : Observational
Estimated Enrollment : 350 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 : December 31, 2023
Estimated Study Completion Date : December 31, 2023

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 CSCC in a real-world setting per standard of care. In addition to (or substituting for) cemiplimab, patients may receive other therapies as deemed necessary by their physicians for the treatment of CSCC or comorbid conditions.
    Other Names:
    • REGN2810
    • Libtayo


Primary Outcome Measures :
  1. Quality of Life (QOL) [ Time Frame: Up to 36 months ]
    Quality of life will be measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and EORTC QLQ-Head and Neck module 35 (H&N35)

  2. Overall Survival (OS) [ Time Frame: Up to 36 months ]
  3. Disease reoccurrence rate [ Time Frame: Up to 36 months ]
  4. Disease response rate of CSCC for cemiplimab-rwlc [ Time Frame: Up to 36 months ]
  5. Disease control rate of CSCC for cemiplimab-rwlc [ Time Frame: Up to 36 months ]
    Percentage of patients with CSCC who have achieved complete response, partial response and stable disease with REGN2810



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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 in a real-world setting.
Criteria

Key Inclusion Criteria:

  • Receiving treatment with cemiplimab for CSCC, or initiating treatment with cemiplimab for CSCC

Key Exclusion Criteria:

  • Receiving cemiplimab for an indication other than CSCC
  • Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study

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
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United States, New York
Regeneron Research Facility Recruiting
Nyack, New York, United States, 10960
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceutical, Inc.

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03836105     History of Changes
Other Study ID Numbers: R2810-ONC-1806
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
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://errs.regeneron.com/external

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell