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)
- Conditions
- Advanced Non-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05557591
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase 2: BNT116 + Cemiplimab BNT116 Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W. Phase 2: Cemiplimab Cemiplimab Arm A: Cemiplimab is administered by IV infusion Q3W Phase 2: BNT116 + Cemiplimab Cemiplimab Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.
- Primary Outcome Measures
Name Time Method 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) 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 Measures
Name Time Method Duration of Response (DOR) as assessed by BIRC using RECIST 1.1 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
DOR by investigator assessment 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
Progression Free Survival (PFS) as assessed by BIRC using RECIST 1.1 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
ORR by investigator assessment Up to 136 weeks from randomization Proportion of patients with a best overall response of confirmed CR or PR
Incidence of treatment-emergent adverse events (TEAEs) 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.
PFS by investigator assessment 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
Overall Survival (OS) Up to 3 years from last patient randomized The time from enrollment to the date of death due to any cause
Incidences of serious adverse events (SAEs) 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 eventIncidences of deaths Up to 3 years Incidences of laboratory abnormalities Up to 3 years According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Causality grading system (โฅ Grade 3 or higher)
Trial Locations
- Locations (57)
Clinica Universidad de Navarra - Madrid
๐ช๐ธMadrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
๐ช๐ธMadrid, Spain
Hospital Regional Universitario de Mรกlaga
๐ช๐ธMalaga, Spain
Hospital Universitario Virgen del Rocio
๐ช๐ธMalaga, Spain
Clinica Universidad de Navarra
๐ช๐ธPamplona, Spain
Instituto Valenciano de Oncologia
๐ช๐ธValencia, Spain
Hospital Universitari i Politecnic La Fe de Valencia
๐ช๐ธValencia, Spain
Ankara Bilkent Sehir Hastanesi
๐น๐ทAnkara, Turkey
LLC Todua Clinic
๐ฌ๐ชTbilisi, Georgia
Bezmialem Foundation University Medical Faculty
๐น๐ทIstanbul, Turkey
IAU VM Medical Park Hospital
๐น๐ทIstanbul, Turkey
Virginia Cancer Specialists
๐บ๐ธFairfax, Virginia, United States
San Juan Oncology Associates
๐บ๐ธFarmington, New Mexico, United States
National Taiwan University Hospital
๐จ๐ณTaipei, Taiwan
The Oncology Institute of Hope and Innovation
๐บ๐ธLos Angeles, California, United States
University of California Irvine
๐บ๐ธOrange, California, United States
UCLA Medical Center
๐บ๐ธSanta Monica, California, United States
Norton Cancer Institute, Downtown
๐บ๐ธLouisville, Kentucky, United States
Dana Farber/Harvard Cancer Center
๐บ๐ธBoston, Massachusetts, United States
Weill Cornell Medicine
๐บ๐ธNew York, New York, United States
Oncology Specialists of Charlotte PA
๐บ๐ธCharlotte, North Carolina, United States
FirstHealth of the Carolinas Outpatient Cancer Center
๐บ๐ธPinehurst, North Carolina, United States
Millenium Research & Clinical Development
๐บ๐ธHouston, Texas, United States
Northwest Medical Specialties, PLLC
๐บ๐ธTacoma, Washington, United States
LTD High Technology Hospital Medcenter
๐ฌ๐ชBatumi, Georgia
LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
๐ฌ๐ชTbilisi, Georgia
LTD New Hospitals
๐ฌ๐ชTbilisi, Georgia
LTD Cancer Research Centre
๐ฌ๐ชTbilisi, Georgia
Caucasus Medical Centre
๐ฌ๐ชTbilisi, Georgia
Staedtisches Klinikum Muenchen Bogenhausen
๐ฉ๐ชMunchen, Bavaria, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
๐ฉ๐ชFrankfurt am Main, Germany
Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen
๐ฉ๐ชGiessen, Germany
Krankenhaus Martha-Maria Halle-Doelau gGmbH
๐ฉ๐ชHalle, Germany
Klinikverbund Kempten-Oberallgรคu
๐ฉ๐ชKempten, Germany
Korea University Anam Hospital
๐ฐ๐ทSeoul, Gyeonggi, Korea, Republic of
Chonnam National University Hwasun Hospital
๐ฐ๐ทHwasun, Jeonnam, Korea, Republic of
National Cancer Center Korea
๐ฐ๐ทGoyang, Korea, Republic of
Seoul National University Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Asan Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Yonsei Severance
๐ฐ๐ทSeoul, Korea, Republic of
Samsung Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Catalan Institute of Oncology Badalona
๐ช๐ธBadalona, Barcelona, Spain
Althaia Xarxa Assistencial Universitaria Manresa
๐ช๐ธManresa, Barcelona, Spain
Consorcio Hospitalario Provincial de Castellon
๐ช๐ธCastello de la Plana, Castellon, Spain
Hospital General Universitario Gregorio Maraรฑon (HGUGM)
๐ช๐ธMadrid, Spain
Kaohsiung Medical University - Chung-Ho Memorial Hospital
๐จ๐ณKaohsiung, Taiwan
Taipei Tzu Chi Hospital
๐จ๐ณNew Taipei City, Taiwan
Taipei Medical University - Shuang Ho Hospital
๐จ๐ณNew Taipei City, Taiwan
Tri-Service General Hospital
๐จ๐ณTaipei City, Taiwan
Baskent University
๐น๐ทYuregir, Adana, Turkey
Yeditepe University Kosuyolu Hospital
๐น๐ทKadikoy, Istanbul, Turkey
Ege University Medical Faculty
๐น๐ทBornova, Izmir, Turkey
Adana Medical Park Seyhan Hospital
๐น๐ทAdana, Seyhan, Turkey
Ozel Liv Hospital
๐น๐ทAnkara, Turkey
Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam
๐น๐ทAnkara, Turkey
Istanbul Medeniyet University Prof. Dr. Suleyman Yalcin Sehir Hospital
๐น๐ทIstanbul, Turkey
Izmir Medicalpark Hospital
๐น๐ทIzmir, Turkey