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)

Advanced Non-Small Cell Lung Cancer Clinical Trial

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%

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557591
• Other study ID #: R2810-ONC-2045
• Secondary ID: 2021-006901-3120
• Status: Recruiting
• Phase: Phase 2
• Start date: April 21, 2023
• Est. completion date: June 7, 2027

Study information

• Verified date: May 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 7, 2027
• Est. primary completion date: March 2, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria

1. Participants with non-squamous or squamous histology NSCLC with stage IIIB or stage IIIC disease who are not candidates for surgical resection or definitive chemoradiation per investigator assessment or stage IV (metastatic) disease who received no prior systemic treatment for recurrent or metastatic NSCLC

2. Availability of an archival or on-study obtained formalin-fixed, paraffin-embedded tumor tissue sample as defined in the protocol.

3. Expression of Programmed cell death ligand-1 (PD-L1) =50%, as described in the protocol.

4. Participants must have at least 1 radiographically measurable lesion by computerized tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria

5. Eastern Cooperative Oncology Group (ECOG) performance status =1 Key Exclusion Criteria

1. Participants who have never smoked, defined as smoking =100 cigarettes in a lifetime

2. Active or untreated brain metastases or spinal cord compression. Participants are eligible if central nervous system (CNS) metastases are adequately treated and patients have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to enrollment

3. Participants with tumors tested positive for epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations, or C-ros oncogene receptor tyrosine kinase 1 (ROS1) fusions

4. Encephalitis, meningitis, or uncontrolled seizures in the year prior to enrollment

5. Participants with history of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years

6. Prior splenectomy

7. Uncontrolled infection with human immunodeficiency virus (HIV), HBV or hepatitis C infection (HCV); or diagnosis of immunodeficiency as defined in the protocol

8. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk of immune-related treatment-emergent adverse events (imTEAEs)

9. Participants requiring corticosteroid therapy (>5 mg prednisone/day or equivalent) within 14 days of randomization

10. Another malignancy that is progressing or requires treatment, except for non melanomatous skin cancer that has undergone potentially curative therapy, in situ cervical carcinoma, or any other localized tumor that has been treated, and the participant is deemed to be in complete remission for at least 2 years prior to enrollment, and no additional therapy is required during the study period

11. Documented or suspected ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as defined in the protocol

12. Patients who have received prior systemic therapies for NSCLC are excluded except for

of the following:

1. Adjuvant or neoadjuvant platinum-based doublet chemotherapy (after surgery and/or radiation therapy) if recurrent or metastatic disease develops more than 6 months after completing therapy if toxicities have resolved to CTCAE grade =1 or baseline except for alopecia and peripheral neuropathy.

2. Anti-PD-(L)1 with or without LAG-3 as an adjuvant or neoadjuvant therapy as long as the last dose is >12 months prior to enrollment.

3. Prior exposure to other immunomodulatory or vaccine therapies as an adjuvant or neoadjuvant therapy such as anti-cytotoxic T lymphocyte-associated antigen (anti-CTLA-4) antibodies if the last dose is >6 months prior to enrollment

13. History or current evidence of significant cardiovascular disease including, myocarditis, congestive heart failure (as defined by New York Heart Association Functional Classification III and IV), unstable angina, serious uncontrolled arrhythmia, and myocardial infarction 6 months prior to study enrollment.

14. Hypersensitivity to cemiplimab or BNT116 or any of their excipients, or contraindicated to cemiplimab per approved local labeling.

15. Patients treated with immunostimulatory agents that may influence the efficacy of the investigational medicinal products (IMPs) are not allowed if they received such agents within 6 weeks or five halve lives of the drug. Note: Other protocol-defined Inclusion/Exclusion criteria apply

Related Conditions & MeSH terms

• Advanced Non-Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• BNT116
BNT116 is administered by IV injection.
• Cemiplimab
Cemiplimab is administered Q3W by IV infusion

Locations

Country	Name	City	State
Georgia	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
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	Staedtisches Klinikum Muenchen Bogenhausen	Muenchen
Korea, Republic of	National Cancer Center Korea	Goyang
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeonnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul	Gyeonggi
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei Severance	Seoul
Spain	Catalan Institute of Oncology Badalona	Badalona
Spain	Althaia, Xarxa Assistencial Universitària Manresa	Barcelona
Spain	Consorcio hospitalario provincial de castellon	Castello
Spain	Clinica Universidad de Navarra - Madrid	Madrid
Spain	Hospital General Universitario Gregorio Marañon (HGUGM)	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	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Instituto Valenciano de Oncologia	Valencia
Taiwan	Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University - Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Taipei Medical University - Shuang Ho Hospital	New Taipei City
Taiwan	National Taiwan University Hosptial	Taipei
Taiwan	Tri-Service General Hospital	Taipei City
Turkey	Adana Medical Park Seyhan Hospital	Adana	Seyhan
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara
Turkey	Baskent University Faculty of Medicine Ankara Hospital	Ankara	Bahcelievler
Turkey	Liv Hospital	Ankara
Turkey	Sbu Dr. A.Y. Ankara Onkoloji Suam	Ankara
Turkey	Ege University Medical Faculty	Bornova	Izmir
Turkey	Bezmialem Foundation University Medical Faculty	Istanbul
Turkey	IAU VM Medical Park Hospital	Istanbul
Turkey	Istanbul Medeniyet University Prof. Dr. Suleyman Yalcin Sehir Hospital	Istanbul
Turkey	Izmir Medicalpark Hospital	Izmir
Turkey	Yeditepe University Kosuyolu Hospital	Kadikoy	Istanbul
United States	Dana Farber/Harvard Cancer Center	Boston	Massachusetts
United States	Oncology Specialists of Charlotte Pa	Charlotte	North Carolina
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	San Juan Oncology Associates	Farmington	New Mexico
United States	Millenium Research & Clinical Development	Houston	Texas
United States	The Oncology Institute of Hope and Innovation	Los Angeles	California
United States	Norton Cancer Institute, Downtown	Louisville	Kentucky
United States	Weill Cornell Medical College	New York	New York
United States	University of California Irvine	Orange	California
United States	FirstHealth of the Carolinas, Inc.	Pinehurst	North Carolina
United States	UCLA Medical Center	Santa Monica	California
United States	Northwest Medical Specialties, PLLC	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	BioNTech SE

Countries where clinical trial is conducted

United States,  Georgia,  Germany,  Korea, Republic of,  Spain,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Proportion of patients with a best overall response of confirmed complete response (CR) or partial response (PR)	Up to 136 weeks from randomization
Secondary	ORR by investigator assessment	Proportion of patients with a best overall response of confirmed CR or PR	Up to 136 weeks from randomization
Secondary	Duration of Response (DOR) as assessed by BIRC using RECIST 1.1	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	Up to 3 years from last patient randomized
Secondary	DOR by investigator assessment	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	Up to 3 years from last patient randomized
Secondary	Progression Free Survival (PFS) as assessed by BIRC using RECIST 1.1	The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier	Up to 3 years from last patient randomized
Secondary	PFS by investigator assessment	The time from randomization to the date of the first radiographic progression or death due to any cause, whichever occurred earlier	Up to 3 years from last patient randomized
Secondary	Overall Survival (OS)	The time from enrollment to the date of death due to any cause	Up to 3 years from last patient randomized
Secondary	Incidence of treatment-emergent adverse events (TEAEs)	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.	Up to 3 years
Secondary	Incidences of serious adverse events (SAEs)	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	Up to 3 years
Secondary	Incidences of deaths		Up to 3 years
Secondary	Incidences of laboratory abnormalities	According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Causality grading system (= Grade 3 or higher)	Up to 3 years