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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Randomized Arm: This is a prospective, open label, randomized, controlled, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System in patients enrolled with NYHA Class II Heart Failure. Single Arm:This is a prospective, open label, single arm, controlled, multicenter clinical trial to evaluate the safety and effectiveness of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in patients enrolled with NYHA Class III Heart Failure comparedto a Performance Goal (PG).
Study LTI-401 is an open-label, multicenter study which will evaluate the safety and tolerability of LIQ861 in subjects who have WHO Group 1 & 3 PH.
Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression.