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)
Running, not enrolling · Phase 2
Conditions studied: Advanced Non-Small Cell Lung Cancer
In brief
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)
Key facts
- Study ID
- NCT05557591
- Run by
- Regeneron Pharmaceuticals
- People needed
- 51
- Starts
- 2023-04-21
- Expected to finish
- 2028-05-16
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA Medical Center — Santa Monica, California, United States
- Norton Cancer Institute, Downtown — Louisville, Kentucky, United States
- San Juan Oncology Associates — Farmington, New Mexico, United States
- Weill Cornell Medicine — New York, New York, United States
- FirstHealth of the Carolinas Outpatient Cancer Center — 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 New Hospitals — Tbilisi, Georgia
- LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic — Tbilisi, Georgia
- LTD Cancer Research Centre — Tbilisi, Georgia
- Caucasus Medical Centre — Tbilisi, Georgia
- Staedtisches Klinikum Muenchen Bogenhausen — München, Bavaria, Germany
- Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt — Frankfurt, Germany
- Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen — Giessen, Germany
- Krankenhaus Martha-Maria Halle-Doelau gGmbH — Halle, Germany
- Klinikverbund Kempten-Oberallgäu — Kempten, Germany
- Korea University Anam Hospital — Seoul, Gyeonggi-do, South Korea
- Chonnam National University Hwasun Hospital — Hwasun, Jeollanam-do, South Korea
- National Cancer Center Korea — Goyang, South Korea
- Asan Medical Center — Seoul, South Korea
- Yonsei Severance — Seoul, South Korea
- The Oncology Institute of Hope and Innovation — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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