ACTIVE_NOT_RECRUITING

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)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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%

Quick Facts

Study Start:2023-04-21
Study Completion:2028-05-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05557591

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

The Oncology Institute of Hope and Innovation
Los Angeles, California, 90033
United States
UCLA Medical Center
Santa Monica, California, 90095
United States
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202
United States
San Juan Oncology Associates
Farmington, New Mexico, 87401
United States
Weill Cornell Medicine
New York, New York, 10065
United States
FirstHealth of the Carolinas Outpatient Cancer Center
Pinehurst, North Carolina, 28374
United States
Millenium Research & Clinical Development
Houston, Texas, 77090
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-21
Study Completion Date2028-05-16

Study Record Updates

Study Start Date2023-04-21
Study Completion Date2028-05-16

Terms related to this study

Keywords Provided by Researchers

  • Cancer Vaccine
  • Immunotherapy
  • Programmed cell death ligand-1 (PD-L1) monoclonal antibody
  • Treatment naïve Advanced Non-Small Cell Lung Cancer (NSCLC)
  • EMPOWERVAX Lung 1

Additional Relevant MeSH Terms

  • Advanced Non-Small Cell Lung Cancer