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JOURNAL ONKOLOGIE – STUDIE

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)

Rekrutierend

NCT-Nummer:
NCT05557591

Studienbeginn:
April 2023

Letztes Update:
21.06.2024

Wirkstoff:
BNT116, Cemiplimab

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Regeneron Pharmaceuticals

Collaborator:
BioNTech SE

Studienleiter

Clinical Trial Management
Study Director
Regeneron Pharmaceuticals

Kontakt

Studienlocations
(3 von 55)

Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
60590 Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen
80336 Giessen
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Krankenhaus Martha-Maria Halle-Doelau gGmbH
6120 Halle
(Sachsen-Anhalt)
GermanyNoch nicht rekrutierend» Google-Maps
Klinikverbund Kempten-Oberallgäu
87439 Kempten
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Staedtisches Klinikum Muenchen Bogenhausen
81925 Muenchen
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
The Oncology Institute of Hope and Innovation
90033 Los Angeles
United StatesRekrutierend» Google-Maps
University of California Irvine
92697 Orange
United StatesZurückgezogen» Google-Maps
UCLA Medical Center
90095 Santa Monica
United StatesRekrutierend» Google-Maps
Norton Cancer Institute, Downtown
40202 Louisville
United StatesRekrutierend» Google-Maps
Dana Farber/Harvard Cancer Center
02215 Boston
United StatesRekrutierend» Google-Maps
San Juan Oncology Associates
87401 Farmington
United StatesRekrutierend» Google-Maps
Weill Cornell Medical College
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
Oncology Specialists of Charlotte Pa
28204 Charlotte
United StatesRekrutierend» Google-Maps
FirstHealth of the Carolinas, Inc.
28374 Pinehurst
United StatesRekrutierend» Google-Maps
Millenium Research & Clinical Development
77090 Houston
United StatesAbgeschlossen» Google-Maps
Virginia Cancer Specialists
22031 Fairfax
United StatesRekrutierend» Google-Maps
Northwest Medical Specialties, PLLC
98405 Tacoma
United StatesRekrutierend» Google-Maps
LTD High Technology Hospital Medcenter
6000 Batumi
GeorgiaRekrutierend» Google-Maps
LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
0144 Tbilisi
GeorgiaRekrutierend» Google-Maps
Korea University Anam Hospital
2841 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Hwasun
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
National Cancer Center Korea
10408 Goyang
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Seoul National University Hospital
03080 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Yonsei Severance
3722 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Samsung Medical Center
6351 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Catalan Institute of Oncology Badalona
08916 Badalona
SpainNoch nicht rekrutierend» Google-Maps
Althaia, Xarxa Assistencial Universitària Manresa
08243 Barcelona
SpainRekrutierend» Google-Maps
Consorcio hospitalario provincial de castellon
12002 Castello
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon (HGUGM)
28007 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Clinica Universidad de Navarra - Madrid
28027 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Fundacion Jimenez Diaz
28040 Madrid
SpainRekrutierend» Google-Maps
Hospital Regional Universitario de Málaga
29010 Malaga
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio
29010 Malaga
SpainRekrutierend» Google-Maps
Clinica Universidad de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps
Instituto Valenciano de Oncologia
46009 Valencia
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitari i Politecnic La Fe de Valencia
46026 Valencia
SpainRekrutierend» Google-Maps
Chung-Ho Memorial Hospital
807 Kaohsiung
TaiwanNoch nicht rekrutierend» Google-Maps
Kaohsiung Medical University - Chung-Ho Memorial Hospital
807 Kaohsiung
TaiwanNoch nicht rekrutierend» Google-Maps
Taipei Medical University - Shuang Ho Hospital
23561 New Taipei City
TaiwanNoch nicht rekrutierend» Google-Maps
Tri-Service General Hospital
114 Taipei City
TaiwanNoch nicht rekrutierend» Google-Maps
National Taiwan University Hosptial
100 Taipei
TaiwanNoch nicht rekrutierend» Google-Maps
Baskent University Faculty of Medicine Ankara Hospital
06490 Ankara
TurkeyNoch nicht rekrutierend» Google-Maps
Yeditepe University Kosuyolu Hospital
34718 Kadikoy
TurkeyNoch nicht rekrutierend» Google-Maps
Ege University Medical Faculty
35040 Bornova
TurkeyNoch nicht rekrutierend» Google-Maps
Adana Medical Park Seyhan Hospital
01140 Adana
TurkeyNoch nicht rekrutierend» Google-Maps
Sbu Dr. A.Y. Ankara Onkoloji Suam
06100 Ankara
TurkeyAktiv, nicht rekrutierend» Google-Maps
Ankara Bilkent Sehir Hastanesi
06800 Ankara
TurkeyNoch nicht rekrutierend» Google-Maps
Bezmialem Foundation University Medical Faculty
34093 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
IAU VM Medical Park Hospital
34295 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Istanbul Medeniyet University Prof. Dr. Suleyman Yalcin Sehir Hospital
81450 Istanbul
TurkeyNoch nicht rekrutierend» Google-Maps
Izmir Medicalpark Hospital
35000 Izmir
TurkeyNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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)

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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) (Time Frame - 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:

1. ORR by investigator assessment (Time Frame - Up to 136 weeks from randomization):
Proportion of patients with a best overall response of confirmed CR or PR

2. Duration of Response (DOR) as assessed by BIRC using RECIST 1.1 (Time Frame - 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

3. DOR by investigator assessment (Time Frame - 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

4. Progression Free Survival (PFS) as assessed by BIRC using RECIST 1.1 (Time Frame - 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

5. PFS by investigator assessment (Time Frame - 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

6. Overall Survival (OS) (Time Frame - Up to 3 years from last patient randomized):
The time from enrollment to the date of death due to any cause

7. Incidence of treatment-emergent adverse events (TEAEs) (Time Frame - 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.

8. Incidences of serious adverse events (SAEs) (Time Frame - 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

9. Incidences of deaths (Time Frame - Up to 3 years)

10. Incidences of laboratory abnormalities (Time Frame - Up to 3 years):
According to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Causality grading system (≥ Grade 3 or higher)

Studien-Arme

  • Experimental: Phase 2: Cemiplimab
    Arm A: Cemiplimab is administered by IV infusion Q3W
  • Experimental: Phase 2: BNT116 + Cemiplimab
    Arm B: BNT116 is administered by IV injection. Cemiplimab is administered by IV infusion Q3W.

Geprüfte Regime

  • BNT116:
    BNT116 is administered by IV injection.
  • Cemiplimab (REGN2810 / Libtayo / ):
    Cemiplimab is administered Q3W by IV infusion

Quelle: ClinicalTrials.gov


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