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
- Conditions
- nresectable head and neck squamous cell carcinoma, metastatic head and neck cancer, recurrent head and neck cancerMedDRA version: 26.1Level: PTClassification code: 10060121Term: Squamous cell carcinoma of head and neck Class: 100000004864MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-512671-12-00
- Lead Sponsor
- BioNTech SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 277
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., Patients have adequate bone marrow function as defined by hematological parameters., Patients have adequate hepatic function., Patients should have adequate kidney function, assessed by the estimated glomerular filtration rate (eGFR) =30 mL/min/min/1.73m² using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation., Patients should be stable with adequate coagulation, as determined by the investigator., 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., 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., Patients must be aged =18 years on the date of signing the informed consent., Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the trial., Patients who present with histologically confirmed recurrent or metastatic HPV16+ HNSCC that is considered incurable by local therapies., 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., The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx., 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., 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 are considered measurable, if progression has been demonstrated in such lesions by RECIST 1.1., Patients have Eastern Cooperative Oncology Group (ECOG) performance status =1.
Patients are pregnant or breastfeeding., Patients who have received or currently receive the following therapy/medication: 1. 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. 2. 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 adverse events (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. 3. Prior treatment with live-attenuated vaccines within 4 weeks before the first dose of BNT113. 4. Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or 5 half-lives of the agent (whichever is longer) before the planned first dose of BNT113. 5. Ongoing treatment with therapeutic PO or IV antibiotics., Prior treatment with anti-cancer immunomodulating agents, such as blockers of programmed death receptor-1 (PD-1), PD-L1, tumor necrosis factor receptor superfamily member 9 (TNRSF9, 4 1BB, CD137), OX 40, therapeutic vaccines, cytokine treatments, or any investigational agent within 4 weeks or 5 half-lives of the agent (whichever is longer) before the first dose of BNT113., Treatment with non-systemic anti-cancer therapy (e.g., radiotherapy or surgery) within 2 weeks prior to randomization., 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., Current evidence of new or growing brain or spinal metastases during screening. Patients with known brain or spinal metastases may be eligible if they: 1. had radiotherapy or another appropriate therapy for the brain or spinal metastases, 2. have no neurological symptoms (excluding Grade =2 neuropathy), 3. have no evidence of clinical or radiological progression within 4 weeks before signing the informed consent, 4. do not require steroid therapy within 7 days before randomization or are undergoing slow steroid tapering, currently at doses =10 mg and neurologically stable. 5. spinal bone metastases are allowed, unless imminent fracture or cord compression is anticipated., Patients who have previously been enrolled in this trial (rescreening is allowed once)., 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., Patients affiliated with the investigational site (e.g., a close relative of the investigator or dependent person, such as an employee or student of the trial site) or sponsor. For patients meeting this criterion, a prospective exception and eventual contingencies to be put in place may be defined on a case-by-case basis by the local Institutional Review Board., Patients that have disease suitable for local therapy administer
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method