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)

Trial status:Recruiting
Trial ID:
R2810-ONC-2045
NCT ID:
NCT05557591
EudraCT ID:
2021-006901-31
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
Regeneron Pharmaceuticals
Recruiting

Trial Details

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)
Medical Condition
  • Lung Cancer
    • Trial Drug
  • BNT116
    • See more
  • Cemiplimab
    • Phase
    Phase 2
    Type
    Interventional
    Estimated Enrolment
    100
    Estimated Trial Date
    Apr 2023 - Mar 2027

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female & Male
    Healthy Volunteers
    No

    Trial Locations

    Location
    Status
    Location
    The Oncology Institute of Hope and Innovation
    Los Angeles, California, United States, 90033
    Status
    Recruiting
    Location
    University of California Irvine
    Orange, California, United States, 92697
    Status
    Withdrawn
    Location
    UCLA Medical Center
    Santa Monica, California, United States, 90095
    Status
    Recruiting
    Location
    Norton Cancer Institute, Downtown
    Louisville, Kentucky, United States, 40202
    Status
    Recruiting
    Location
    Dana Farber/Harvard Cancer Center
    Boston, Massachusetts, United States, 02215
    Status
    Terminated
    Location
    San Juan Oncology Associates
    Farmington, New Mexico, United States, 87401
    Status
    Recruiting