This trial has two parts. Part A, an initial non-randomized Safety Run-In Phase to confirm the safety and tolerability at the selected dose range level of BNT113 in combination with pembrolizumab. Part B, the Randomized Phase of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy to generate pivotal efficacy and safety data in the first line setting in patients with unresectable recurrent or metastatic HPV16+ HNSCC expressing PD-L1 with CPS ≥1. Randomization will be stratified by PDL1 CPS <20 vs PD-L1 CPS ≥20, and prior chemotherapy (yes vs no).
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Working closely together, our clinical teams care for patients from birth through their late teenage years. At Tufts Medical Center in Boston, we strive to keep the children and adolescents of our community healthy by providing routine primary care as well as emergency care and day surgery.
Originally founded in 1893, we are a 234-bed general hospital offering a wide range of services, including expert cardiac care, 24-hour emergency care, wound care management and maternity services with an on-site Level II Special Care Nursery. We are the only hospital in the area offering an emergency cardiac catheterization lab, a life-saving procedure to open blocked arteries and limit heart damage. We are supported by over 700 affiliated physicians and have access to advanced specialty care with our clinical affiliation with Tufts Medical Center.
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Tufts Medicine Specialty Pharmacy is here to help you manage your disease and the specialty medications used to treat it. We provide you with services beyond just filling your prescriptions. We will guide you through your treatment plan and work with you and your doctors to achieve the best possible treatment outcome. We use the most current treatment information for common conditions, diagnoses, diagnostic procedures and medical interventions to ensure safe and effective drug therapy.