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JOURNAL ONKOLOGIE – STUDIE

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Rekrutierend

NCT-Nummer:
NCT06054555

Studienbeginn:
November 2023

Letztes Update:
21.06.2024

Wirkstoff:
ABP 206, Nivolumab

Indikation (Clinical Trials):
Melanoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Amgen

Collaborator:
-

Studienleiter

MD
Study Director
Amgen

Kontakt

Studienlocations
(3 von 100)

Goethe University Hospital
60590 Frankfurt/Main
(Hessen)
GermanyRekrutierend» Google-Maps
University Hospital Cologne AöR
50937 Köln
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Cancer and Blood Specialty Clinic
90806 Long Beach
United StatesRekrutierend» Google-Maps
Ft Wayne Med Oncology Hematology
46804 Fort Wayne
United StatesRekrutierend» Google-Maps
Our Lady of the Lake Physician Grp MO
70805 Baton Rouge
United StatesRekrutierend» Google-Maps
University of Maryland Medical Center-Greenebaum Cancer Ctr
21201 Baltimore
United StatesRekrutierend» Google-Maps
Oncology Hematology Associates
65807-5287 Springfield
United StatesRekrutierend» Google-Maps
Hematology-Oncology Associates-CNY
13057 East Syracuse
United StatesRekrutierend» Google-Maps
University Clinical Center of Republic of Srpska
78000 Banja Luka
Bosnia and HerzegovinaRekrutierend» Google-Maps
University Clinical Hospital Mostar
88000 Mostar
Bosnia and HerzegovinaRekrutierend» Google-Maps
Clinical Center University of Sarajevo
71000 Sarajevo
Bosnia and HerzegovinaRekrutierend» Google-Maps
University Clinical Center Tuzla
75000 Tuzla
Bosnia and HerzegovinaRekrutierend» Google-Maps
Cantonal hospital Zenica
72000 Zenica
Bosnia and HerzegovinaRekrutierend» Google-Maps
Dr. Everett Chalmers Hospital
E3B 5N5 Fredericton
CanadaRekrutierend» Google-Maps
University Hospital Centre Zagreb
10 000 Zagreb
CroatiaRekrutierend» Google-Maps
Klinicki bolnicki centar Osijek
31000 Osijek
CroatiaRekrutierend» Google-Maps
Vseobecna fakultni nemocnice v Praze
128 08 Praha 2
CzechiaRekrutierend» Google-Maps
C.H.R.U Hopital Claude Huriez - Dermatologie
59037 Lille
FranceRekrutierend» Google-Maps
ISR-GEO Med Res Clin Healthycore
0112 Tbilisi
GeorgiaRekrutierend» Google-Maps
JSC KE Nat Ctr of Exp and Clin Surg
0159 Tbilisi
GeorgiaRekrutierend» Google-Maps
Multprofil Clinic Consilium Medulla
0186 Tbilisi
GeorgiaRekrutierend» Google-Maps
Istituto dei Tumori "Giovanni Paolo II"
70124 Bari
ItalyRekrutierend» Google-Maps
IEO - Istituto Europeo di Oncologia, IRCCS
20141 Milano
ItalyRekrutierend» Google-Maps
Azienda Ospedaliera Universitaria Federico II
80131 Napoli
ItalyRekrutierend» Google-Maps
Fondazione IRCCS Policlinico San Matteo
27100 Pavia
ItalyRekrutierend» Google-Maps
IRCCS IFO, Istituto Nazionale dei Tumori Regina Elena (IRE)
00144 Roma
ItalyRekrutierend» Google-Maps
Istituto Dermopatico dell'Immacolata (IDI) - IRCCS
00167 Roma
ItalyRekrutierend» Google-Maps
AOU Senese, Policlinico Le Scotte
53100 Siena
ItalyRekrutierend» Google-Maps
Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi
21100 Varese
ItalyRekrutierend» Google-Maps
National Cancer Institute
LT-08660 Vilnius
LithuaniaRekrutierend» Google-Maps
Hospital Universiti Sains Malaysia
16150 Kubang Kerian
MalaysiaRekrutierend» Google-Maps
Hospital Canselor Tuanku Muhriz UKM
56000 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps
Pantai Hospital Kuala Lumpur
59100 Kuala Lumpur
MalaysiaRekrutierend» Google-Maps
Preparaciones Oncologicas SC
C. P. 37178 Leon
MexicoRekrutierend» Google-Maps
Centro Inmuno Oncolog de Occidente
44630 Guadalajara
MexicoRekrutierend» Google-Maps
I CAN ONCOLOGY CENTER SA de CV
64710 Monterrey
MexicoRekrutierend» Google-Maps
Cent de Estud y Prev del Cancer AC
70000 Juchitan
MexicoRekrutierend» Google-Maps
Ctro At Inv Cardio Potosi
78200 San Luis Potosi
MexicoRekrutierend» Google-Maps
Neurociencias Estudios Clínicos SC
80020 Culiacan
MexicoRekrutierend» Google-Maps
Centro De Atenc E Inv Clín En Onco
97134 Merida
MexicoRekrutierend» Google-Maps
Centro de Inv Medica Aguascalientes
20115 Aguascalientes
MexicoRekrutierend» Google-Maps
Clinica Integral Internac Oncologia
72530 Puebla
MexicoRekrutierend» Google-Maps
Althian Research Management Center
66278 San Pedro Garza Garcia
MexicoRekrutierend» Google-Maps
Centro Medico Zambrano Hellion
66278 San Pedro Garza García
MexicoRekrutierend» Google-Maps
Clinical Research Institute S.C.
Tlalnepantla de Baz
MexicoRekrutierend» Google-Maps
Baguio General Hospital and Medical Center
2600 Baguio City
PhilippinesRekrutierend» Google-Maps
Center for Skin Research Testing
1229 Makati City
PhilippinesRekrutierend» Google-Maps
Cardinal Santos Madical Center
1502 San Juan City
PhilippinesRekrutierend» Google-Maps
Cebu Doctors' University Hospital
1000 Cebu City
PhilippinesRekrutierend» Google-Maps
Unidade Local de Saúde da Arrábida, E. P. E.
Setubal
PortugalRekrutierend» Google-Maps
Champalimaud Foundation - Champalimaud Centre for the Unknown (Champalimaud Cancer Center)
1400-038 Lisboa
PortugalRekrutierend» Google-Maps
Hospital de São Francisco Xavier
1449-005 Lisboa
PortugalRekrutierend» Google-Maps
Instituto Portugues de Oncologia de Lisboa Francisco Gentil
Lisboa
PortugalRekrutierend» Google-Maps
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
400015 Cluj-Napoca
RomaniaRekrutierend» Google-Maps
Centrul de Oncologie Sf. Nectarie
200746 Craiova
RomaniaRekrutierend» Google-Maps
Oncocenter-Oncologie Clinica
300166 Timisoara
RomaniaRekrutierend» Google-Maps
Centrul de Oncologie Euroclinic
700106 Iasi
RomaniaRekrutierend» Google-Maps
Spitalul Clinic Judetean De Urgenta Sibiu
550245 Sibiu
RomaniaRekrutierend» Google-Maps
Vojvodina Institute for Oncology
21204 Sremska Kamenica
SerbiaRekrutierend» Google-Maps
University Clinical Center Kragujevac
34000 Kragujevac
SerbiaRekrutierend» Google-Maps
Hospital Universitario Virgen De La Macarena
41009 Sevilla
SpainRekrutierend» Google-Maps
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
08916 Badalona
SpainRekrutierend» Google-Maps
Hospital San Pedro de Alcántara
10003 Caceres
SpainRekrutierend» Google-Maps
Hospital de La Santa Creu i Sant Pau
08025 Barcelona
SpainRekrutierend» Google-Maps
Hospital Universitari Vall D Hebron
08035 Barcelona
SpainRekrutierend» Google-Maps
Hospital Regional Universitario de Malaga
29010 Málaga
SpainRekrutierend» Google-Maps
Consorcio Hospital General Universitario de Valencia
46014 Valencia
SpainRekrutierend» Google-Maps
Changhua Christian Medical Foundation Changhua Christian Hospital
50006 Changhua
TaiwanRekrutierend» Google-Maps
Khon Kaen University, Srinagarind Hospital
40002 Khonkaen
ThailandRekrutierend» Google-Maps
King Chulalongkorn Memorial Hospital [Medical Oncology]
10330 Bangkok
ThailandRekrutierend» Google-Maps
Ramathibodi Hospital, Mahidol University
10400 Bangkok
ThailandRekrutierend» Google-Maps
Prince of Songkla University
90110 Songkhla
ThailandRekrutierend» Google-Maps
Gulhane Egitim ve Arastirma Hastanesi Tibbi Onkoloji Klinigi
06010 Ankara
TurkeyRekrutierend» Google-Maps
Medical Point Gaziantep Hospital
27010 Gaziantep
TurkeyRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Detailed Description:

Eligible subjects will be randomized (1:1) to receive investigational product (ABP 206 or

nivolumab).

All subjects will be treated until disease progression, unacceptable toxicity, or subject

withdrawal of consent for a maximum of 24 months of treatment.

The total duration of study participation for each subject will be approximately 26 months.

Ein-/Ausschlusskriterien

Key Inclusion Criteria:

- At least 18 years of age.

- Histologically confirmed unresectable or metastatic melanoma.

- Subject has no prior systemic treatment for advanced disease.

- Subject must have measurable disease according to Response Evaluation Criteria in

Solid Tumors (RECIST version 1.1).

- Tumor tissue from site of unresectable or metastatic melanoma must be available for

biomarker analyses in order to be randomized.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Key Exclusion Criteria:

- Subject has had any prior systemic anti-cancer therapy for the treatment of advanced

melanoma.

- Known hypersensitivity to monoclonal antibodies or to any of the excipients of the

study drug.

- Subject has active central nervous system (CNS) metastases not previously treated.

- Ocular melanoma.

- Subject has active or known immune-mediated disorders.

- Subject has had prior treatment with PD-1/PD-L1 and cytotoxic T lymphocyte- associated

protein 4 inhibitors, or other antibodies targeting immune checkpoint pathways.

- Subject has medical conditions requiring systemic immunosuppression with either

corticosteroids or other immunosuppressive medications within 14 days of the first

dose of investigational product.

Other protocol-defined inclusion/exclusion criteria apply.

Studien-Rationale

Primary outcome:

1. Objective response by Week 49 (Time Frame - Week 49)

2. Objective response at Week 17 (Time Frame - Week 17)

3. Progression-free survival (PFS) (Time Frame - From Randomization until Follow-up or End of treatment (EOT) or Early termination (ET) (Approximately 105 Weeks))

4. Overall survival (OS) (Time Frame - From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks))

5. Duration of response (DOR) (Time Frame - From Randomization until Follow-up or EOT or ET (Approximately 105 Weeks))

Secondary outcome:

1. Number of subjects with treatment-emergent adverse events (Time Frame - Week 1 until Week 105)

2. Number of subjects with treatment-emergent serious adverse events (Time Frame - Week 1 until Week 105)

3. Number of subjects with treatment-emergent adverse events of interest (Time Frame - Week 1 until Week 105)

4. Number of subjects with anti-drug antibodies (Time Frame - Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105)

5. Serum concentrations of ABP 206 and nivolumab (Ctrough) (Time Frame - Predose on Week 1 (Baseline), Weeks 9, 17, 29, 41, 53, 65, 77, 89, 101 and Week 105)

Studien-Arme

  • Experimental: ABP 206
    Subjects will receive Dose A of ABP 206 via intravenous (IV) infusion.
  • Active Comparator: Nivolumab
    Subjects will receive Dose A of Nivolumab via IV infusion.

Geprüfte Regime

  • ABP 206:
    ABP 206 will be given intravenously over a period of 30 or 60 minutes, every 4 weeks (Q4W) for a total of 24 months.
  • Nivolumab (OPDIVO®):
    Nivolumab will be given intravenously over a period of 30 or 60 minutes, Q4W for a total of 24 months.

Quelle: ClinicalTrials.gov


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