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)

Phase 2

Recruiting

• Conditions: Advanced Non-Small Cell Lung Cancer
• Interventions: Drug: BNT116; Drug: Cemiplimab

• 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

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-23
• Study First Posted: 2022-09-28
• Study Start: 2023-04-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2027-03-02
• Study Completion: 2027-06-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

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 event
Incidences 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 (≥ Grade 3 or higher)

Trial Locations

Locations (57)

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

Ankara Bilkent Sehir Hastanesi; 🇹🇷 Ankara, Turkey

LLC Todua Clinic; 🇬🇪 Tbilisi, Georgia

Bezmialem Foundation University Medical Faculty; 🇹🇷 Istanbul, Turkey

IAU VM Medical Park Hospital; 🇹🇷 Istanbul, Turkey

Virginia Cancer Specialists; 🇺🇸 Fairfax, Virginia, United States

San Juan Oncology Associates; 🇺🇸 Farmington, New Mexico, United States

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

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

Weill Cornell Medicine; 🇺🇸 New York, New York, United States

Oncology Specialists of Charlotte PA; 🇺🇸 Charlotte, North Carolina, United States

FirstHealth of the Carolinas Outpatient Cancer Center; 🇺🇸 Pinehurst, North Carolina, United States

Millenium Research & Clinical Development; 🇺🇸 Houston, Texas, United States

Northwest Medical Specialties, PLLC; 🇺🇸 Tacoma, Washington, United States

LTD High Technology Hospital Medcenter; 🇬🇪 Batumi, Georgia

LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic; 🇬🇪 Tbilisi, Georgia

LTD New Hospitals; 🇬🇪 Tbilisi, Georgia

LTD Cancer Research Centre; 🇬🇪 Tbilisi, Georgia

Caucasus Medical Centre; 🇬🇪 Tbilisi, Georgia

Staedtisches Klinikum Muenchen Bogenhausen; 🇩🇪 Munchen, Bavaria, Germany

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

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, Barcelona, Spain

Althaia Xarxa Assistencial Universitaria Manresa; 🇪🇸 Manresa, Barcelona, Spain

Consorcio Hospitalario Provincial de Castellon; 🇪🇸 Castello de la Plana, Castellon, Spain

Hospital General Universitario Gregorio Marañon (HGUGM); 🇪🇸 Madrid, Spain

Kaohsiung Medical University - Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Taipei Tzu Chi Hospital; 🇨🇳 New Taipei City, Taiwan

Taipei Medical University - Shuang Ho Hospital; 🇨🇳 New Taipei City, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei City, Taiwan

Baskent University; 🇹🇷 Yuregir, Adana, Turkey

Yeditepe University Kosuyolu Hospital; 🇹🇷 Kadikoy, Istanbul, Turkey

Ege University Medical Faculty; 🇹🇷 Bornova, Izmir, Turkey

Adana Medical Park Seyhan Hospital; 🇹🇷 Adana, Seyhan, Turkey

Ozel Liv Hospital; 🇹🇷 Ankara, Turkey

Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam; 🇹🇷 Ankara, Turkey

Istanbul Medeniyet University Prof. Dr. Suleyman Yalcin Sehir Hospital; 🇹🇷 Istanbul, Turkey

Izmir Medicalpark Hospital; 🇹🇷 Izmir, Turkey