A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt 60590 Frankfurt am Main (Hessen) GermanyNoch nicht rekrutierend» Google-MapsUniversitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen 80336 Giessen (Hessen) GermanyNoch nicht rekrutierend» Google-MapsKrankenhaus Martha-Maria Halle-Doelau gGmbH 6120 Halle (Sachsen-Anhalt) GermanyNoch nicht rekrutierend» Google-Maps
Klinikverbund Kempten-Oberallgäu 87439 Kempten (Bayern) GermanyNoch nicht rekrutierend» Google-MapsStaedtisches Klinikum Muenchen Bogenhausen 81925 Muenchen (Bayern) GermanyNoch nicht rekrutierend» Google-MapsThe Oncology Institute of Hope and Innovation 90033 Los Angeles United StatesRekrutierend» Google-MapsUniversity of California Irvine 92697 Orange United StatesZurückgezogen» Google-MapsUCLA Medical Center 90095 Santa Monica United StatesRekrutierend» Google-MapsNorton Cancer Institute, Downtown 40202 Louisville United StatesRekrutierend» Google-MapsDana Farber/Harvard Cancer Center 02215 Boston United StatesRekrutierend» Google-MapsSan Juan Oncology Associates 87401 Farmington United StatesRekrutierend» Google-MapsWeill Cornell Medical College 10065 New York United StatesNoch nicht rekrutierend» Google-MapsOncology Specialists of Charlotte Pa 28204 Charlotte United StatesRekrutierend» Google-MapsFirstHealth of the Carolinas, Inc. 28374 Pinehurst United StatesRekrutierend» Google-MapsMillenium Research & Clinical Development 77090 Houston United StatesAbgeschlossen» Google-MapsVirginia Cancer Specialists 22031 Fairfax United StatesRekrutierend» Google-MapsNorthwest Medical Specialties, PLLC 98405 Tacoma United StatesRekrutierend» Google-MapsLTD High Technology Hospital Medcenter 6000 Batumi GeorgiaRekrutierend» Google-MapsLLC Todua Clinic 0112 Tbilisi GeorgiaRekrutierend» Google-MapsLTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic 0144 Tbilisi GeorgiaRekrutierend» Google-MapsLTD New Hospitals 0162 Tbilisi GeorgiaRekrutierend» Google-MapsKorea University Anam Hospital 2841 Seoul Korea, Republic ofNoch nicht rekrutierend» Google-MapsChonnam National University Hwasun Hospital 58128 Hwasun Korea, Republic ofNoch nicht rekrutierend» Google-MapsNational Cancer Center Korea 10408 Goyang Korea, Republic ofNoch nicht rekrutierend» Google-MapsSeoul National University Hospital 03080 Seoul Korea, Republic ofNoch nicht rekrutierend» Google-MapsAsan Medical Center 05505 Seoul Korea, Republic ofNoch nicht rekrutierend» Google-MapsYonsei Severance 3722 Seoul Korea, Republic ofNoch nicht rekrutierend» Google-MapsSamsung Medical Center 6351 Seoul Korea, Republic ofNoch nicht rekrutierend» Google-MapsCatalan Institute of Oncology Badalona 08916 Badalona SpainNoch nicht rekrutierend» Google-MapsAlthaia, Xarxa Assistencial Universitària Manresa 08243 Barcelona SpainRekrutierend» Google-MapsConsorcio hospitalario provincial de castellon 12002 Castello SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Marañon (HGUGM) 28007 Madrid SpainNoch nicht rekrutierend» Google-MapsClinica Universidad de Navarra - Madrid 28027 Madrid SpainRekrutierend» Google-MapsHospital Universitario Fundacion Jimenez Diaz 28040 Madrid SpainRekrutierend» Google-MapsHospital Regional Universitario de Málaga 29010 Malaga SpainNoch nicht rekrutierend» Google-MapsHospital Universitario Virgen del Rocio 29010 Malaga SpainRekrutierend» Google-MapsClinica Universidad de Navarra 31008 Pamplona SpainRekrutierend» Google-MapsInstituto Valenciano de Oncologia 46009 Valencia SpainNoch nicht rekrutierend» Google-MapsHospital Universitari i Politecnic La Fe de Valencia 46026 Valencia SpainRekrutierend» Google-MapsChung-Ho Memorial Hospital 807 Kaohsiung TaiwanNoch nicht rekrutierend» Google-MapsKaohsiung Medical University - Chung-Ho Memorial Hospital 807 Kaohsiung TaiwanNoch nicht rekrutierend» Google-MapsTaipei Medical University - Shuang Ho Hospital 23561 New Taipei City TaiwanNoch nicht rekrutierend» Google-MapsTri-Service General Hospital 114 Taipei City TaiwanNoch nicht rekrutierend» Google-MapsNational Taiwan University Hosptial 100 Taipei TaiwanNoch nicht rekrutierend» Google-MapsBaskent University Faculty of Medicine Ankara Hospital 06490 Ankara TurkeyNoch nicht rekrutierend» Google-MapsYeditepe University Kosuyolu Hospital 34718 Kadikoy TurkeyNoch nicht rekrutierend» Google-MapsEge University Medical Faculty 35040 Bornova TurkeyNoch nicht rekrutierend» Google-MapsAdana Medical Park Seyhan Hospital 01140 Adana TurkeyNoch nicht rekrutierend» Google-MapsSbu Dr. A.Y. Ankara Onkoloji Suam 06100 Ankara TurkeyAktiv, nicht rekrutierend» Google-MapsLiv Hospital 06680 Ankara TurkeyNoch nicht rekrutierend» Google-MapsAnkara Bilkent Sehir Hastanesi 06800 Ankara TurkeyNoch nicht rekrutierend» Google-MapsBezmialem Foundation University Medical Faculty 34093 Istanbul TurkeyNoch nicht rekrutierend» Google-MapsIAU VM Medical Park Hospital 34295 Istanbul TurkeyNoch nicht rekrutierend» Google-MapsIstanbul Medeniyet University Prof. Dr. Suleyman Yalcin Sehir Hospital 81450 Istanbul TurkeyNoch nicht rekrutierend» Google-MapsIzmir Medicalpark Hospital 35000 Izmir TurkeyNoch nicht rekrutierend» Google-Maps
1. Objective response rate (ORR) as assessed by blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) (Time Frame - Up to 136 weeks from randomization): Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)
Secondary outcome:
1. ORR by investigator assessment (Time Frame - Up to 136 weeks from randomization): Proportion of patients with a best overall response of confirmed CR or PR
2. Duration of Response (DOR) as assessed by BIRC using RECIST 1.1 (Time Frame - Up to 3 years from last patient randomized): The time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR
3. DOR by investigator assessment (Time Frame - Up to 3 years from last patient randomized): The time from first response of CR or PR to first radiographic progression or death due to any cause for patients with confirmed CR or PR
4. Progression Free Survival (PFS) as assessed by BIRC using RECIST 1.1 (Time Frame - Up to 3 years from last patient randomized): The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier
5. PFS by investigator assessment (Time Frame - Up to 3 years from last patient randomized): The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier
6. Overall Survival (OS) (Time Frame - Up to 3 years from last patient randomized): The time from enrollment to the date of death due to any cause
7. Incidence of treatment-emergent adverse events (TEAEs) (Time Frame - Up to 3 years): A TEAE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
8. Incidences of serious adverse events (SAEs) (Time Frame - Up to 3 years): An SAE is any untoward medical occurrence that at any dose:
Results in death - includes all deaths, even those that appear to be completely unrelated to study drug (eg, a car accident in which a patient is a passenger)
Is life-threatening
Requires in-patient hospitalization or prolongation of existing hospitalization
Results in persistent or significant disability/incapacity
Is a congenital anomaly/birth defect
Is an important medical event
9. Incidences of deaths (Time Frame - Up to 3 years)
10. Incidences of laboratory abnormalities (Time Frame - Up to 3 years): According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Causality grading system (≥ Grade 3 or higher)
Cemiplimab (REGN2810 / Libtayo / ): Cemiplimab is administered Q3W by IV infusion
Quelle: ClinicalTrials.gov
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"A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)"
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