Spots Global Cancer Trial Database for 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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Trial Identification
Brief Title: 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)
Official Title: A Phase 2 Study of Cemiplimab (Anti-PD-1 Antibody) in Combination With BNT116 (FixVac Lung) Versus Cemiplimab Monotherapy in First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With Tumors Expressing PD-L1 ≥50%
Study ID: NCT05557591
Conditions
Study Description
Brief Summary: This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a "study drug", and together be called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab is compared to cemiplimab by itself at treating cancer. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects)
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Oncology Institute of Hope and Innovation, Los Angeles, California, United States
University of California Irvine, Orange, California, United States
UCLA Medical Center, Santa Monica, California, United States
Norton Cancer Institute, Downtown, Louisville, Kentucky, United States
Dana Farber/Harvard Cancer Center, Boston, Massachusetts, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
Weill Cornell Medical College, New York, New York, United States
Oncology Specialists of Charlotte Pa, Charlotte, North Carolina, United States
FirstHealth of the Carolinas, Inc., Pinehurst, North Carolina, United States
Millenium Research & Clinical Development, Houston, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
LTD High Technology Hospital Medcenter, Batumi, , Georgia
LLC Todua Clinic, Tbilisi, , Georgia
LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic, Tbilisi, , Georgia
LTD New Hospitals, Tbilisi, , Georgia
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt, Frankfurt am Main, , Germany
Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen, Giessen, , Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH, Halle, , Germany
Klinikverbund Kempten-Oberallgäu, Kempten, , Germany
Staedtisches Klinikum Muenchen Bogenhausen, Muenchen, , Germany
Korea University Anam Hospital, Seoul, Gyeonggi, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, Jeonnam, Korea, Republic of
National Cancer Center Korea, Goyang, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Yonsei Severance, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Catalan Institute of Oncology Badalona, Badalona, , Spain
Althaia, Xarxa Assistencial Universitària Manresa, Barcelona, , Spain
Consorcio hospitalario provincial de castellon, Castello, , Spain
Hospital General Universitario Gregorio Marañon (HGUGM), Madrid, , Spain
Clinica Universidad de Navarra - Madrid, Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Regional Universitario de Málaga, Malaga, , Spain
Hospital Universitario Virgen del Rocio, Malaga, , Spain
Clinica Universidad de Navarra, Pamplona, , Spain
Instituto Valenciano de Oncologia, Valencia, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Taipei Medical University - Shuang Ho Hospital, New Taipei City, , Taiwan
Tri-Service General Hospital, Taipei City, , Taiwan
National Taiwan University Hosptial, Taipei, , Taiwan
Baskent University Faculty of Medicine Ankara Hospital, Ankara, Bahcelievler, Turkey
Yeditepe University Kosuyolu Hospital, Kadikoy, Istanbul, Turkey
Ege University Medical Faculty, Bornova, Izmir, Turkey
Sbu Dr. A.Y. Ankara Onkoloji Suam, Ankara, , Turkey
Liv Hospital, Ankara, , Turkey
Ankara Bilkent Sehir Hastanesi, Ankara, , Turkey
Bezmialem Foundation University Medical Faculty, Istanbul, , Turkey
IAU VM Medical Park Hospital, Istanbul, , Turkey
Istanbul Medeniyet University Prof. Dr. Suleyman Yalcin Sehir Hospital, Istanbul, , Turkey
Izmir Medicalpark Hospital, Izmir, , Turkey
Medical Park Seyhan Hospital, Seyhan, , Turkey
Contact Details
Name: Clinical Trial Management
Affiliation: Regeneron Pharmaceuticals
Role: STUDY_DIRECTOR
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