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
Study Director
Regeneron Pharmaceuticals
Kontakt
Kontakt:
E-Mail: clinicaltrials@regeneron.com» Kontaktdaten anzeigen
Studienlocations
(3 von 95)
Hoppe-Seyler-Straße 3
72076 Tübingen
DeutschlandRekrutierend» Google-Maps
80337 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandAbgeschlossen» Google-Maps
Hufelandstraße 55
45147 Essen
DeutschlandAktiv, nicht rekrutierend» Google-Maps
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
24105 Kiel
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
07548 Gera
(Thüringen)
GermanyRekrutierend» Google-Maps
85004 Phoenix
United StatesAktiv, nicht rekrutierend» Google-Maps
85054 Phoenix
United StatesAbgeschlossen» Google-Maps
91010 Duarte
United StatesAktiv, nicht rekrutierend» Google-Maps
90095 Los Angeles
United StatesAktiv, nicht rekrutierend» Google-Maps
94063 Redwood City
United StatesAktiv, nicht rekrutierend» Google-Maps
92161 San Diego
United StatesAktiv, nicht rekrutierend» Google-Maps
80045 Aurora
United StatesAktiv, nicht rekrutierend» Google-Maps
33140 Miami Beach
United StatesAktiv, nicht rekrutierend» Google-Maps
33612 Tampa
United StatesAktiv, nicht rekrutierend» Google-Maps
60611 Chicago
United StatesAktiv, nicht rekrutierend» Google-Maps
40202 Louisville
United StatesAbgeschlossen» Google-Maps
02114 Boston
United StatesAbgeschlossen» Google-Maps
02130 Boston
United StatesAktiv, nicht rekrutierend» Google-Maps
48201 Detroit
United StatesAktiv, nicht rekrutierend» Google-Maps
63104 Saint Louis
United StatesAbgeschlossen» Google-Maps
63110 Saint Louis
United StatesAktiv, nicht rekrutierend» Google-Maps
68114 Omaha
United StatesAbgeschlossen» Google-Maps
10016 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
10021 New York
United StatesAbgeschlossen» Google-Maps
14623 Rochester
United StatesAbgeschlossen» Google-Maps
44195 Cleveland
United StatesAktiv, nicht rekrutierend» Google-Maps
18015 Easton
United StatesAktiv, nicht rekrutierend» Google-Maps
17033 Hershey
United StatesAbgeschlossen» Google-Maps
29407 Charleston
United StatesAktiv, nicht rekrutierend» Google-Maps
77030 Houston
United StatesAktiv, nicht rekrutierend» Google-Maps
84112 Salt Lake City
United StatesAktiv, nicht rekrutierend» Google-Maps
Garran
AustraliaNoch nicht rekrutierend» Google-Maps
Camperdown
AustraliaNoch nicht rekrutierend» Google-Maps
Gosford
AustraliaRekrutierend» Google-Maps
Kogarah
AustraliaZurückgezogen» Google-Maps
Liverpool
AustraliaNoch nicht rekrutierend» Google-Maps
2065 St Leonards
AustraliaRekrutierend» Google-Maps
Waratah
AustraliaRekrutierend» Google-Maps
Bundaberg
AustraliaNoch nicht rekrutierend» Google-Maps
4029 Herston
AustraliaRekrutierend» Google-Maps
Southport
AustraliaNoch nicht rekrutierend» Google-Maps
Urraween
AustraliaNoch nicht rekrutierend» Google-Maps
Woolloongabba
AustraliaRekrutierend» Google-Maps
5037 Kurralta Park
AustraliaRekrutierend» Google-Maps
Hobart
AustraliaNoch nicht rekrutierend» Google-Maps
3000 Melbourne
AustraliaRekrutierend» Google-Maps
Wodonga
AustraliaNoch nicht rekrutierend» Google-Maps
6009 Nedlands
AustraliaRekrutierend» Google-Maps
Lismore
AustraliaNoch nicht rekrutierend» Google-Maps
Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Curitiba
BrazilNoch nicht rekrutierend» Google-Maps
Ipatinga
BrazilNoch nicht rekrutierend» Google-Maps
Lages
BrazilNoch nicht rekrutierend» Google-Maps
Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
São Paulo
BrazilNoch nicht rekrutierend» Google-Maps
59037 Lille
FranceRekrutierend» Google-Maps
93000 Bobigny
FranceRekrutierend» Google-Maps
33000 Bordeaux
FranceRekrutierend» Google-Maps
21079 Dijon
FranceRekrutierend» Google-Maps
38043 Grenoble
FranceRekrutierend» Google-Maps
13009 Marseille
FranceRekrutierend» Google-Maps
44093 Nantes
FranceRekrutierend» Google-Maps
75014 Paris
FranceRekrutierend» Google-Maps
75475 Paris
FranceRekrutierend» Google-Maps
69495 Pierre Bénite
FranceRekrutierend» Google-Maps
51092 Reims
FranceZurückgezogen» Google-Maps
94085 Villejuif
FranceRekrutierend» Google-Maps
16121 Athens
GreeceRekrutierend» Google-Maps
Napoli
ItalyRekrutierend» Google-Maps
Genova
ItalyNoch nicht rekrutierend» Google-Maps
Milano
ItalyNoch nicht rekrutierend» Google-Maps
Rozzano
ItalyZurückgezogen» Google-Maps
Padova
ItalyNoch nicht rekrutierend» Google-Maps
Bergamo
ItalyZurückgezogen» Google-Maps
Brescia
ItalyRekrutierend» Google-Maps
L'Aquila
ItalyRekrutierend» Google-Maps
20141 Milano
ItalyRekrutierend» Google-Maps
Roma
ItalyNoch nicht rekrutierend» Google-Maps
Torino
ItalyNoch nicht rekrutierend» Google-Maps
Hamilton
New ZealandNoch nicht rekrutierend» Google-Maps
Rotorua
New ZealandNoch nicht rekrutierend» Google-Maps
08908 L'Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
08036 Barcelona
SpainRekrutierend» Google-Maps
08035 Barcelona
SpainRekrutierend» Google-Maps
08916 Barcelona
SpainRekrutierend» Google-Maps
14004 Cordoba
SpainRekrutierend» Google-Maps
28034 Madrid
SpainRekrutierend» Google-Maps
28040 Madrid
SpainRekrutierend» Google-Maps
28041 Madrid
SpainRekrutierend» Google-Maps
39008 Santander
SpainRekrutierend» Google-Maps
46009 Valencia
SpainRekrutierend» Google-Maps
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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