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A Clinical Trial Investigating the Safety, Tolerability, and Therapeutic Effects of BNT113 in Combination With Pembrolizumab Versus Pembrolizumab Alone for Patients With a Form of Head and Neck Cancer Positive for Human Papilloma Virus 16 and Expressing the Protein PD-L1
285 patients around the world
Available in Argentina, United States, Spain
BioNTech SE
28Research sites
285Patients around the world
This study is for people with
Head and neck cancer
Squamous cell carcinoma of the head and neck
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Pre-screening phase (optional - patients can alternatively perform tumor biomarker testing as part of the main screening phase): Patients must sign the written pre-screening informed consent form (ICF) before any pre-screening procedures.Pre-screening phase (optional - patients can alternatively perform tumor biomarker testing as part of the main screening phase): Patients must have histologically confirmed recurrent or metastatic HNSCC with no prior systemic anticancer therapy administered in the recurrent or metastatic (R/M) setting.Pre-screening phase (optional - patients can alternatively perform tumor biomarker testing as part of the main screening phase): Patients have a clinical situation at a relatively high risk of developing R/M disease.Pre-screening phase (optional - patients can alternatively perform tumor biomarker testing as part of the main screening phase): Patients do not meet any exclusion criteria for the main clinical trial, except for time-dependent (e.g., prior systemic treatment in the prior 6 months) or potentially reversible conditions that in the opinion of the investigator will be resolved prior to potential enrollment into the main phase.Main trial: Patients must sign the written informed consent form before any screening procedure. Informed consent must be documented before any trial-specific screening procedure is performed.Main trial: Patients must be aged ≥18 years on the date of signing the informed consent.Main trial: Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the trial.Main trial: Patients who present histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies.Main trial: Patients who have a tumor that expresses PD-L1 [CPS ≥1] as determined by the approved test PD-L1 IHC 22C3 pharmDx kit performed and evaluated according to the manufacturer's specifications and relevant regulatory approvals.Main trial: The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.Main trial: Patients must not have had prior systemic anticancer therapy administered in the incurable recurrent or metastatic setting. Systemic therapy which was completed more than 6 months prior to randomization, if given as part of multimodal treatment for locally advanced disease, is allowed.Main trial: Patients who have measurable disease based on RECIST 1.1 as determined by the site and confirmed by BICR. Tumor lesions situated in a previously irradiated area may be considered measurable, if progression has been demonstrated in such lesions disease by RECIST 1.1.Main trial: Patients have Eastern Cooperative Oncology Group (ECOG) performance status ≤1.Main trial: Patients have adequate bone marrow function as defined by hematological parameters.Main trial: Patients have adequate hepatic function.Main trial: Patients should have adequate kidney function, assessed by the estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m^2 using the Chronic Kidney Disease Epidemiology Collaboration (CPK-EPI) equation.Main trial: Patients should be stable with adequate coagulation, as determined by the investigator.Main trial: All patients must provide a tumor tissue sample (formalin fixed paraffin embedded [FFPE] blocks or both slides and curls) from archival tissue, or fresh biopsy if a biopsy is performed as part of the patient's standard clinical practice before the first dose of trial treatment.Main trial: Women of childbearing potential (WOCBP) must not be pregnant. WOCBP, male patients who are sexually active with WOCBP and female partners of male patients should use a highly effective method of contraception up to at least 6 months after receiving the last dose of trial treatment, and should agree not to donate eggs (ova, oocytes) or sperm.
- Medical conditions: Patients are pregnant or breastfeeding.Medical conditions: Patients present primary tumor site of nasopharynx (any histology).Medical conditions: Patients with uncontrolled intercurrent illness, including but not limited to: Ongoing or active infection which requires systemic treatment with antibiotics on the first dose of trial treatment.Medical conditions: Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), myocardial infarction within 3 months before screening, unstable angina pectoris, or cardiac arrhythmia.Medical conditions: Arterial thrombosis or pulmonary embolism within ≤6 months before the start of trial treatment, if not on a stable dose of anticoagulants or if in the opinion of the investigator contra-indicates trial inclusion.Medical conditions: Evidence or history of interstitial lung disease that, in the opinion of the investigator, is a contraindication for treatment with pembrolizumab, or active non-infectious pneumonitis.Medical conditions: Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg, despite optimal medical management. Patients with arterial hypertension need to be on stable anti-hypertensive medication for at least 4 weeks prior to trial entry.Medical conditions: Known primary immunodeficiencies.Medical conditions: Evidence or history of significant autoimmune disease that (a) required treatment with systemic immunosuppressive treatments, (b) was associated with ongoing treatment with corticosteroids, or (c) was associated with a record of significant end-organ dysfunction (even if transient), which in the opinion of the investigator may suggest increased risk for immune-related AEs.Medical conditions: Patients with prior allogeneic stem cell or solid organ transplantation.Medical conditions: Any other disease, metabolic dysfunction, physical examination finding, and/or laboratory finding giving reasonable suspicion of a disease or condition that in the opinion of the investigator contraindicates the use of an investigational drug or may render the patient at high risk for complications.Medical conditions: Patients with a known allergy, hypersensitivity, or intolerance to BNT113 or its excipients, or to pembrolizumab or its excipients.Medical conditions: Patients who have had a splenectomy.Medical conditions: Patients who have had major surgery (e.g., requiring general anesthesia) within 4 weeks before screening, or have not fully recovered from surgery, or have major surgery planned during the time of trial participation.Medical conditions: Patients who have a known history or a positive test at screening of any of the following: Human immunodeficiency virus (HIV) 1 or 2. Inclusion is allowed if HIV 1/2 infection is adequately controlled and stable on a highly effective antiviral regimen.Medical conditions: Patients with another primary malignancy that has not been in complete remission for at least 2 years, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, non-invasive basal or non-invasive squamous cell skin cancer, localized prostate cancer, non-invasive superficial bladder cancer or breast ductal carcinoma in situ).Medical conditions: Patients with any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.Prior/concomitant therapy: Patients who have received or currently receive the following therapy/medication: Chronic systemic immunosuppressive treatment including corticosteroid treatment (prednisone >10 mg daily orally [PO] or intravenously [IV], or equivalent) in the 7 days prior to the first dose of trial treatment.Prior/concomitant therapy: Prior treatment with other immune modulating agents that was (a) within fewer than 4 weeks (28 days) or 5 half-lives of the agent (whichever is longer) prior to the first dose of BNT113, or (b) associated with immune-mediated AEs that have not resolved prior to the first dose of BNT113 or that pose an additional risk of on-trial complications, per investigator's assessment, or (c) associated with toxicity that resulted in discontinuation of the immune-modulating agent and that poses an additional risk of on-trial complications, per investigator's assessment.Prior/concomitant therapy: Patients who have previously been enrolled in this trial (rescreening is allowed once).Other comorbidities: Current evidence of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade >1 toxicity before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria. Patients with Grade 2 neuropathy may be eligible at investigator's discretion.Other comorbidities: Current evidence of new or growing brain or spinal metastases during screening. Patients with known brain or spinal metastases may be eligible if they: had radiotherapy or another appropriate therapy for the brain or spinal metastases, have no neurological symptoms (excluding Grade ≤2 neuropathy), have no evidence of clinical or radiological progression within 4 weeks before signing the informed consent, do not require steroid therapy within 7 days before randomization or are undergoing slow steroid tapering, currently at doses ≤10 mg and neurologically stable, spinal bone metastases are allowed, unless imminent fracture or cord compression is anticipated.Other exclusions: Patients with substance abuse or known medical, psychological, or social conditions that in the opinion of the investigator may interfere with the patient's participation in the trial or evaluation of the trial results.Tumor-related conditions: Patients that have disease suitable for local therapy administered with curative intent.Tumor-related conditions: Patients that have a life expectancy of less than 3 months and/or have rapidly progressive disease, as assessed by the treating investigator.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Recruiting
Centro de Oncología e Investigación Buenos Aires COIBA
Recruiting
Centro de Investigación Pergamino SA
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Sanatorio Británico - Rosario
Recruiting
Centro Médico Caipo (centro para la atención integral de pacientes oncológicos)
Recruiting
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
StudyAHEAD-MERIT
SponsorBioNTech SE
Study typeInterventional
Conditions
Head and neck cancerSquamous cell carcinoma of the head and neck
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04534205
