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CASE: CemiplimAb Survivorship Epidemiology

Sponsor
Regeneron Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03836105
Collaborator
(none)
500
Enrollment
51
Locations
75.1
Anticipated Duration (Months)
9.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase

Study Design

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

Outcome Measures

Primary Outcome Measures

  1. Objective response rate (ORR) [Up to 36 months]

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

  2. Disease control rate (DCR) [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) [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 [Up to 36 months]

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

  5. Progression free survival (PFS) [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) [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) [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) [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 [Up to 36 months]

    Pattern of recurrence

  10. Immune related adverse events (irAEs) [Up to 36 months]

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

  11. Infusion related reactions (IRRs) [Up to 36 months]

    NCI-CTCAE v5

  12. Treatment related serious adverse reactions (SARs) [Up to 36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oncology Specialties, PC - Clearview Cancer Institute Huntsville Alabama United States 35805
2 CARTI Cancer Center Little Rock Arkansas United States 72205
3 University of California San Diego La Jolla California United States 92037
4 Harbor-UCLA/LA Biomedical Research Institute Los Angeles California United States 90502
5 St. Mary's Medical Center San Francisco California United States 94117
6 Regeneron Research Facility Stanford California United States 94063
7 University of Colorado Aurora Colorado United States 80045
8 The Melanoma and Skin Cancer Institute Englewood Colorado United States 80113
9 Regional Cancer Care Associates, LLC Manchester Connecticut United States 06040
10 Integrity Clinical Research Delray Beach Florida United States 33745
11 Mayo Clinic Jacksonville Florida United States 32224
12 Regeneron Research Facility Largo Florida United States 33770
13 Regeneron Research Facility Miami Florida United States 33156
14 Miami Cancer Institute at Baptist Health, Inc. Miami Florida United States 33176
15 Moffitt Cancer Center Tampa Florida United States 33612
16 Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital Thomasville Georgia United States 31792
17 Northwestern University Chicago Illinois United States 60611
18 NorthShore University HealthSystem Evanston Illinois United States 60201
19 Reid Oncology Association Richmond Indiana United States 47374
20 CHRISTUS Highland Cancer Treatment Center Shreveport Louisiana United States 71105
21 Baltimore Veterans Affairs Medical Center Baltimore Maryland United States 21201
22 Frederick Health Frederick Maryland United States 21702
23 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
24 Lahey Hospital & Medical Center Burlington Massachusetts United States 01805
25 University of Michigan Ann Arbor Michigan United States 48109
26 Southeast Nebraska Hematology & Oncology Consultants, PC Lincoln Nebraska United States 68510
27 Optum Cancer Care Las Vegas Nevada United States 89102
28 Regeneron Research Facility Elizabeth New Jersey United States 07202
29 Montefiore Hospital Bronx New York United States 10461
30 Regeneron Research Facility New York New York United States 10016
31 Regeneron Research Facility New York New York United States 10032
32 Regeneron Research Facility Nyack New York United States 10960
33 New York Cancer and Blood Specialists Port Jefferson Station New York United States 11776
34 Oncology Specialists of Charlotte, PA Charlotte North Carolina United States 28204
35 Durham VA Medical Center Durham North Carolina United States 27705
36 Asante Rogue Regional Medical Center Medford Oregon United States 97504
37 Oregon Health & Science University Portland Oregon United States 97239
38 St. Luke's University Health Network Bethlehem Pennsylvania United States 18015
39 Clinical Research Center of the Carolinas Charleston South Carolina United States 29407
40 Charleston Hematology Oncology Associates, PA Charleston South Carolina United States 29414
41 University of Tennessee Medical Center Knoxville Tennessee United States 37920
42 Texas Oncology-Amarillo Cancer Center Amarillo Texas United States 79106
43 Texas Oncology Dallas Texas United States 75246
44 University of Texas Southwestern Dallas Texas United States 75390
45 MD Anderson Cancer Center Houston Texas United States 77030
46 Renovatio Clinical The Woodlands Texas United States 77380
47 University of Vermont Burlington Vermont United States 05401
48 University of Virginia Charlottesville Virginia United States 22908
49 Inova Schar Cancer Institute Fairfax Virginia United States 22031
50 Pan-American Center for Oncology Trials, LLC Rio Piedras Puerto Rico 00902
51 FDI Clinical Research San Juan Puerto Rico 00927

Sponsors and Collaborators

  • Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceutical, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03836105
Other Study ID Numbers:
  • R2810-ONC-1806
First Posted:
Feb 11, 2019
Last Update Posted:
Apr 26, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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:
Carcinoma
Carcinoma, Basal Cell
Cemiplimab

Study Results

No Results Posted as of Apr 26, 2022