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JOURNAL ONKOLOGIE – STUDIE

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Rekrutierend

NCT-Nummer:
NCT02760498

Studienbeginn:
April 2016

Letztes Update:
26.01.2021

Wirkstoff:
Cemiplimab

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Regeneron Pharmaceuticals

Collaborator:
-

Studienleiter

Clinical Trial Management
Study Director
Regeneron Pharmaceuticals

Kontakt

Studienlocations
(3 von 95)

Viszeralonkologisches Zentrum Universitätsklinikum Tübingen
Hoppe-Seyler-Straße 3
72076 Tübingen
DeutschlandRekrutierend» Google-Maps
LMU Klinikum der Universität München
80337 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandAbgeschlossen» Google-Maps
Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
DeutschlandAktiv, nicht rekrutierend» Google-Maps
Universitätsklinikum Carl Gustav Carus
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Schleswig-Holstein
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Charitè Campus Mitte
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
SRH Wald-Klinikum Gera
07548 Gera
(Thüringen)
GermanyRekrutierend» Google-Maps
University of Arizona Cancer Center
85004 Phoenix
United StatesAktiv, nicht rekrutierend» Google-Maps
City of Hope Hospital
91010 Duarte
United StatesAktiv, nicht rekrutierend» Google-Maps
University of California, Los Angeles
90095 Los Angeles
United StatesAktiv, nicht rekrutierend» Google-Maps
Stanford University
94063 Redwood City
United StatesAktiv, nicht rekrutierend» Google-Maps
University of California, San Diego
92161 San Diego
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Colorado, Denver
80045 Aurora
United StatesAktiv, nicht rekrutierend» Google-Maps
Mount Sinai Comprehensive Cancer Center
33140 Miami Beach
United StatesAktiv, nicht rekrutierend» Google-Maps
H. Lee Moffitt Cancer Center
33612 Tampa
United StatesAktiv, nicht rekrutierend» Google-Maps
Northwestern University
60611 Chicago
United StatesAktiv, nicht rekrutierend» Google-Maps
Norton Cancer Institute
40202 Louisville
United StatesAbgeschlossen» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesAbgeschlossen» Google-Maps
Dana-Farber Cancer Institute
02130 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
Barbara Ann Karmanos Cancer Institute
48201 Detroit
United StatesAktiv, nicht rekrutierend» Google-Maps
St. Louis University
63104 Saint Louis
United StatesAbgeschlossen» Google-Maps
Washington University in St. Louis
63110 Saint Louis
United StatesAktiv, nicht rekrutierend» Google-Maps
Nebraska Methodist Hospital
68114 Omaha
United StatesAbgeschlossen» Google-Maps
New York University
10016 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10021 New York
United StatesAbgeschlossen» Google-Maps
University of Rochester Medical Center
14623 Rochester
United StatesAbgeschlossen» Google-Maps
Cleveland Clinic
44195 Cleveland
United StatesAktiv, nicht rekrutierend» Google-Maps
St. Luke's Hematology Oncology Specialists
18015 Easton
United StatesAktiv, nicht rekrutierend» Google-Maps
Penn State Hershey Medical Center
17033 Hershey
United StatesAbgeschlossen» Google-Maps
Dermatology and Laser Center of Charleston
29407 Charleston
United StatesAktiv, nicht rekrutierend» Google-Maps
MD Anderson Cancer Center
77030 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
Huntsman Cancer Institute
84112 Salt Lake City
United StatesAktiv, nicht rekrutierend» Google-Maps
Chris O'Brien Lifehouse Hospital
Camperdown
AustraliaNoch nicht rekrutierend» Google-Maps
Royal North Shore Hospital
2065 St Leonards
AustraliaRekrutierend» Google-Maps
Wide Bay Cancer Care Services
Bundaberg
AustraliaNoch nicht rekrutierend» Google-Maps
Royal Brisbane & Women's Hospital
4029 Herston
AustraliaRekrutierend» Google-Maps
Icon Cancer Care Southport
Southport
AustraliaNoch nicht rekrutierend» Google-Maps
Wide Bay Hospital and Health Services
Urraween
AustraliaNoch nicht rekrutierend» Google-Maps
Princess Alexandra Hospital
Woolloongabba
AustraliaRekrutierend» Google-Maps
Adelaide Cancer Centre
5037 Kurralta Park
AustraliaRekrutierend» Google-Maps
ICON Cancer Care Hobart
Hobart
AustraliaNoch nicht rekrutierend» Google-Maps
Peter MacCallum Cancer Centre
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Border Medical Oncology
Wodonga
AustraliaNoch nicht rekrutierend» Google-Maps
Sir Charles Gairdner Hospital
6009 Nedlands
AustraliaRekrutierend» Google-Maps
Lismore Base Hospital
Lismore
AustraliaNoch nicht rekrutierend» Google-Maps
Hospital de Clinicas de Porto Alegre
Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner
Curitiba
BrazilNoch nicht rekrutierend» Google-Maps
Fundação São Francisco Xavier-Hospital Márcio Cunha
Ipatinga
BrazilNoch nicht rekrutierend» Google-Maps
INCA Instituto Nacional de Cancer
Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Instituto do Cancer do Estado de São Paulo ICESP
Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Fundação Antônio Prudente - AC Camargo Câncer Center
São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire de Nantes
44093 Nantes
FranceRekrutierend» Google-Maps
Centre Hospitalier Lyon Sud
69495 Pierre Bénite
FranceRekrutierend» Google-Maps
Andreas Sygros Hosptial-University of Athen
16121 Athens
GreeceRekrutierend» Google-Maps
Istituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione Giovanni Pascale
Napoli
ItalyRekrutierend» Google-Maps
Istituto Europeo Di Oncologia
Genova
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Nazionale Dei Tumori
Milano
ItalyNoch nicht rekrutierend» Google-Maps
Istituto Oncologico Veneto - I.R.C.C.S.
Padova
ItalyNoch nicht rekrutierend» Google-Maps
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
Bergamo
ItalyZurückgezogen» Google-Maps
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia
ItalyRekrutierend» Google-Maps
Fondazione Policlinico Universitario A Gemelli
Roma
ItalyNoch nicht rekrutierend» Google-Maps
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino
ItalyNoch nicht rekrutierend» Google-Maps
ICO l'Hospitalet - Hospital Duran i Reynals
08908 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Hospital Clinic de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Vall d'Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitario Germans Trias i Pujol
08916 Barcelona
SpainRekrutierend» Google-Maps
C.H. Regional Reina Sofia - PPDS
14004 Cordoba
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Fundacion Jimenez Diaz
28040 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Marques de Valdecilla
39008 Santander
SpainRekrutierend» Google-Maps
Fundacion Instituto Valenciano de Oncología
46009 Valencia
SpainRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

For Groups 1 to 4, the primary objective of this study is to estimate the clinical benefit of

cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous

cell carcinoma (CSCC), or unresectable locally advanced CSCC. For Group 6, the primary

objective is to provide additional efficacy and safety data for cemiplimab monotherapy in

patients with advanced CSCC (metastatic [nodal or distant] or locally advanced. Clinical

benefit is measured by overall response rate (ORR) according to central review in each group.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

- At least 1 measurable lesion

- Eastern Cooperative Oncology Group (ECOG) performance status ≤1

- Adequate bone marrow function

- Adequate renal function

- Adequate hepatic function

- Archived or newly obtained tumor material

- Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4 and 6)

- Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

- Ongoing or recent (within 5 years) evidence of significant autoimmune disease that

required treatment with systemic immunosuppressive treatments, which may suggest risk

for immune-related adverse events

- Prior treatment with an agent that blocks the PD-1/PD-L1pathway

- Prior treatment with a BRAF inhibitor

- Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to

the first dose of cemiplimab, or associated with immune-mediated adverse events that

were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated

with toxicity that resulted in discontinuation of the immune-modulating agent.

Examples of immune-modulating agents include therapeutic vaccines, cytokine

treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB

(CD137), or OX-40.

- Untreated brain metastasis(es) that may be considered active

- Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within

4 weeks prior to the first dose of cemiplimab

- Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with

hepatitis B virus or hepatitis C virus

- History of non-infectious pneumonitis within the last 5 years

- Allergic reactions or acute hypersensitivity reaction attributed to antibody

treatments

- Known allergy to doxycycline or tetracycline

- Patients with a history of solid organ transplant

- Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or

clinical laboratory abnormality that renders the patient unsuitable

Other protocol-defined inclusion/exclusion criteria apply

Studien-Rationale

Primary outcome:

1. Overall Response Rate (Time Frame - 30 months):
Groups 1, 3, 4, and 6: RECIST version 1.1 will be used to determine ORR. Group 2: Clinical response criteria will be used to determine ORR



Secondary outcome:

1. Investigator Assessments of Overall Response Rate (Time Frame - Up to 30 months):
Groups 1-4 and 6

2. Duration of response (Time Frame - Up to 30 months):
Groups 1-4 and 6

3. PFS (progression-free survival) (Time Frame - Up to 30 months):
Groups 1-4 and 6

4. Overall Survival (Time Frame - Up to 30 months):
Groups 1-4 and 6

5. Complete Response (CR) Rate (Time Frame - Up to 30 months)

6. Change in scores of patient reported outcomes on EORTC QLQ-C30 (Time Frame - Up to 30 months)

7. Incidence of Treatment Emergent Adverse Events (TEAEs) (Time Frame - Up to 30 months)

8. Cemiplimab PK: Concentration at end-of-infusion (Ceoi) (IV) (Time Frame - Up to 24 months)

9. Cemiplimab PK: Peak concentrations (Cmax) (SC) (Time Frame - Up to 24 months)

10. Cemiplimab PK: Pre-infusion concentration (Ctrough) (Time Frame - Up to 24 months)

11. Cemiplimab PK: Time of end-of-infusion (teoi) (Time Frame - Up to 24 months)

12. Cemiplimab PK: Time to peak concentration (tmax) (SC) (Time Frame - Up to 24 months)

13. Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose (Time Frame - Up to 24 months)

14. Cemiplimab PK: Absolute bioavailability after SC administration (Time Frame - Up to 24 months)

15. Anti-cemiplimab antibodies (Time Frame - Up to 30 months)

16. Immunohistochemistry (IHC) assessment of correlation between PD-L1 status and ORR (Time Frame - Up to 30 months):
Group 6

17. IHC assessment of correlation between PD-L1 and DOR (Time Frame - Up to 30 months):
Group 6

18. IHC assessment of correlation between PD-L1 and PFS (Time Frame - Up to 30 months):
Group 6

Studien-Arme

  • Experimental: Group 1
    Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 2 weeks.
  • Experimental: Group 2
    Patients with unresectable locally advanced CSCC. Cemiplimab administered intravenously every 2 weeks.
  • Experimental: Group 3
    Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 3 weeks.
  • Experimental: Group 4
    Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered intravenously every 4 weeks.
  • Experimental: Group 6
    Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced). Cemiplimab administered IV every 3weeks.

Geprüfte Regime

  • cemiplimab (REGN2810 / Libtayo / )

Quelle: ClinicalTrials.gov


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