Trial Title:
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)
NCT ID:
NCT05557591
Condition:
Advanced Non-Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Cemiplimab
Conditions: Keywords:
Cancer Vaccine
Immunotherapy
Programmed cell death ligand-1 (PD-L1) monoclonal antibody
Treatment naïve Advanced Non-Small Cell Lung Cancer (NSCLC)
EMPOWERVAX Lung 1
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BNT116
Description:
BNT116 is administered by IV injection.
Arm group label:
Phase 2: BNT116 + Cemiplimab
Intervention type:
Drug
Intervention name:
Cemiplimab
Description:
Cemiplimab is administered Q3W by IV infusion
Arm group label:
Phase 2: BNT116 + Cemiplimab
Arm group label:
Phase 2: Cemiplimab
Other name:
REGN2810
Other name:
Libtayo
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)
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Oncology Institute of Hope and Innovation
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California Irvine
Address:
City:
Orange
Zip:
92697
Country:
United States
Status:
Withdrawn
Facility:
Name:
UCLA Medical Center
Address:
City:
Santa Monica
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Cancer Institute, Downtown
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber/Harvard Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Terminated
Facility:
Name:
San Juan Oncology Associates
Address:
City:
Farmington
Zip:
87401
Country:
United States
Status:
Recruiting
Facility:
Name:
Weill Cornell Medical College
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
Oncology Specialists of Charlotte Pa
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
FirstHealth of the Carolinas, Inc.
Address:
City:
Pinehurst
Zip:
28374
Country:
United States
Status:
Recruiting
Facility:
Name:
Millenium Research & Clinical Development
Address:
City:
Houston
Zip:
77090
Country:
United States
Status:
Terminated
Facility:
Name:
Virginia Cancer Specialists
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Medical Specialties, PLLC
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Facility:
Name:
LTD High Technology Hospital Medcenter
Address:
City:
Batumi
Zip:
6000
Country:
Georgia
Status:
Recruiting
Facility:
Name:
LLC Todua Clinic
Address:
City:
Tbilisi
Zip:
0112
Country:
Georgia
Status:
Recruiting
Facility:
Name:
LTD Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic
Address:
City:
Tbilisi
Zip:
0144
Country:
Georgia
Status:
Recruiting
Facility:
Name:
LTD New Hospitals
Address:
City:
Tbilisi
Zip:
0162
Country:
Georgia
Status:
Recruiting
Facility:
Name:
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Address:
City:
Frankfurt am Main
Zip:
60590
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitaetsklinikum Giessen Und Marburg Gmbh Standort Giessen
Address:
City:
Giessen
Zip:
80336
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Krankenhaus Martha-Maria Halle-Doelau gGmbH
Address:
City:
Halle
Zip:
6120
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Klinikverbund Kempten-Oberallgäu
Address:
City:
Kempten
Zip:
87439
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Staedtisches Klinikum Muenchen Bogenhausen
Address:
City:
Muenchen
Zip:
81925
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Korea University Anam Hospital
Address:
City:
Seoul
Zip:
2841
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Chonnam National University Hwasun Hospital
Address:
City:
Hwasun
Zip:
58128
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
National Cancer Center Korea
Address:
City:
Goyang
Zip:
10408
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Yonsei Severance
Address:
City:
Seoul
Zip:
3722
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
6351
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Catalan Institute of Oncology Badalona
Address:
City:
Badalona
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Althaia, Xarxa Assistencial Universitària Manresa
Address:
City:
Barcelona
Zip:
08243
Country:
Spain
Status:
Recruiting
Facility:
Name:
Consorcio hospitalario provincial de castellon
Address:
City:
Castello
Zip:
12002
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañon (HGUGM)
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra - Madrid
Address:
City:
Madrid
Zip:
28027
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Regional Universitario de Málaga
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Virgen del Rocio
Address:
City:
Malaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Universidad de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Instituto Valenciano de Oncologia
Address:
City:
Valencia
Zip:
46009
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Universitari i Politecnic La Fe de Valencia
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Facility:
Name:
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Taipei Tzu Chi Hospital
Address:
City:
New Taipei City
Zip:
231
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Taipei Medical University - Shuang Ho Hospital
Address:
City:
New Taipei City
Zip:
23561
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Tri-Service General Hospital
Address:
City:
Taipei City
Zip:
114202
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
National Taiwan University Hosptial
Address:
City:
Taipei
Zip:
100225
Country:
Taiwan
Status:
Not yet recruiting
Facility:
Name:
Baskent University Faculty of Medicine Ankara Hospital
Address:
City:
Ankara
Zip:
06490
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Yeditepe University Kosuyolu Hospital
Address:
City:
Kadikoy
Zip:
34718
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Ege University Medical Faculty
Address:
City:
Bornova
Zip:
35040
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Adana Medical Park Seyhan Hospital
Address:
City:
Adana
Zip:
01140
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Sbu Dr. A.Y. Ankara Onkoloji Suam
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Liv Hospital
Address:
City:
Ankara
Zip:
06680
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
Ankara Bilkent Sehir Hastanesi
Address:
City:
Ankara
Zip:
06800
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Bezmialem Foundation University Medical Faculty
Address:
City:
Istanbul
Zip:
34093
Country:
Turkey
Status:
Not yet recruiting
Facility:
Name:
IAU VM Medical Park Hospital
Address:
City:
Istanbul
Zip:
34295
Country:
Turkey
Status:
Withdrawn
Facility:
Name:
Istanbul Medeniyet University Prof. Dr. Suleyman Yalcin Sehir Hospital
Address:
City:
Istanbul
Zip:
81450
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Izmir Medicalpark Hospital
Address:
City:
Izmir
Zip:
35000
Country:
Turkey
Status:
Not yet recruiting
Start date:
April 21, 2023
Completion date:
June 7, 2027
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Collaborator:
Agency:
BioNTech SE
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05557591
