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Clinical trial

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

NCT04534205 is registered in ClinicalTrials.gov with BioNTech SE as lead sponsor.

NCT NCT04534205
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
BioNTech SE
Phase
Phase 2/3
Overall status
Active, not recruiting
Start date
January 7, 2021
Completion date
August 31, 2028
Enrollment
358 (actual)
Sites
138

Conditions

As the registry lists them; a condition with its own page is linked.

metastatic head and neck cancer, recurrent head and neck cancer, unresectable head and neck squamous cell carcinoma