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BNT113

DRUG3 trials

Sponsors

BioNTech SE, University of Southampton

Conditions

Cervical NeoplasmHead and Neck NeoplasmHuman Papilloma Virus Related CarcinomaMetastatic Head and Neck CancerPenile Neoplasms MalignantRecurrent Head and Neck CancerUnknown Primary TumorsUnresectable Head and Neck Squamous Cell Carcinoma

Phase 1

HARE-40: HPV Anti-CD40 RNA vaccinE
CompletedNCT03418480
University of SouthamptonCervical Neoplasm, Head and Neck Neoplasm, Human Papilloma Virus Related Carcinoma +2
Start: 2017-04-11End: 2024-01-24Updated: 2026-09-16

Phase 2

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
Active, not recruitingNCT04534205
BioNTech SEMetastatic Head and Neck Cancer, Recurrent Head and Neck Cancer, Unresectable Head and Neck Squamous Cell Carcinoma
Start: 2021-01-07End: 2028-08-01Updated: 2026-09-08
An open-label Phase II/III randomized trial of BNT113 in combination with pembrolizumab versus pembrolizumab monotherapy as a first line therapy in patients with unresectable recurrent, or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC) which is positive for human papilloma virus 16 (HPV16+) and expresses PD-L1
RecruitingCTIS2024-512671-12-00
BioNTech SEmetastatic head and neck cancer, recurrent head and neck cancer, Unresectable head and neck squamous cell carcinoma
Start: 2021-03-05Target: 98Updated: 2025-12-01

Related Papers

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CLDN6-specific CAR-T cells plus amplifying RNA vaccine in relapsed or refractory solid tumors: the phase 1 BNT211-01 trial
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