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CemiplimAb Survivorship Epidemiology (CASE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03836105
Recruitment Status : Recruiting
First Posted : February 11, 2019
Last Update Posted : July 10, 2020
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 CSCC 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 (SARs) in patients with advanced CSCC 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 CSCC
  • To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with Cutaneous squamous cell carcinoma (CSCC) undergoing treatment with cemiplimab
  • 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 investigate the long-term effects and effectiveness of cemiplimab in CSCC patients
  • To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC, 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

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 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. 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 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 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. Treatment related 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. Treatment related 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 in a real-world setting.
Criteria

Key Inclusion Criteria:

  • Eligible for treatment with and prescribed cemiplimab for advanced CSCC in accordance with approved prescribing information as described in the protocol

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
  • 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
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United States, Alabama
Regeneron Research Facility Recruiting
Huntsville, Alabama, United States, 35805
United States, Arkansas
Regeneron Research Facility Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Regeneron Research Facility Recruiting
La Jolla, California, United States, 92037
Regeneron Research Facility Recruiting
Los Angeles, California, United States, 90502
Regeneron Research Facility Recruiting
San Francisco, California, United States, 94117
Regeneron Research Facility Recruiting
Stanford, California, United States, 94063
United States, Colorado
Regeneron Research Facility Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Regeneron Research Facility Recruiting
Delray Beach, Florida, United States, 33745
Regeneron Research Facility Recruiting
Largo, Florida, United States, 33770
Regeneron Research Facility Recruiting
Miami, Florida, United States, 33156
Regeneron Research Facility Recruiting
Miami, Florida, United States, 33176
United States, Illinois
Regeneron Research Facility Recruiting
Chicago, Illinois, United States, 60611
Regeneron Research Facility Recruiting
Evanston, Illinois, United States, 60201
United States, Indiana
Regeneron Research Facility Recruiting
Richmond, Indiana, United States, 47374
United States, Louisiana
Regeneron Research Facility Recruiting
Shreveport, Louisiana, United States, 71105
United States, Michigan
Regeneron Research Facility Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Nebraska
Regeneron Research Facility Recruiting
Lincoln, Nebraska, United States, 68510
United States, New Jersey
Regeneron Research Facility Recruiting
Elizabeth, New Jersey, United States, 07202
United States, New York
Regeneron Research Facility Recruiting
Bronx, New York, United States, 10461
Regeneron Research Facility Recruiting
New York, New York, United States, 10016
Regeneron Research Facility Recruiting
New York, New York, United States, 10032
Regeneron Research Facility Recruiting
Nyack, New York, United States, 10960
Regeneron Research Facility Recruiting
Port Jefferson Station, New York, United States, 11776
United States, North Carolina
Regeneron Research Facility Recruiting
Charlotte, North Carolina, United States, 28204
United States, Oregon
Regeneron Research Facility Recruiting
Medford, Oregon, United States, 97504
United States, Pennsylvania
Regeneron Research Facility Recruiting
Bethlehem, Pennsylvania, United States, 18015
United States, South Carolina
Regeneron Research Facility Recruiting
Charleston, South Carolina, United States, 29407
Regeneron Research Facility Recruiting
Charleston, South Carolina, United States, 29414
United States, Tennessee
Regeneron Research Facility Recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
Regeneron Research Facility Recruiting
Dallas, Texas, United States, 75390
Regeneron Research Facility Recruiting
The Woodlands, Texas, United States, 77380
United States, Virginia
Regeneron Research Facility Recruiting
Fairfax, Virginia, United States, 22031
Puerto Rico
Regeneron Research Facility Recruiting
Rio Piedras, Puerto Rico, 00902
Regeneron Research Facility Recruiting
San Juan, Puerto Rico, 00927
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: July 10, 2020
Last Verified: June 2020
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
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents