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

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT04534205

Title field or adapter rule

protocolSection.identificationModule.officialTitle

Ingested At

2026-04-25T22:27:54.681273+00:00

Published At

2026-04-15T00:00:00+00:00

Record Updated At

2026-04-15

Timestamp Basis

source retrieval time was not retained by the feed adapter

Date limitation

source retrieval time was not retained by the feed adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Unresectable Head and Neck Squamous Cell Carcinoma", "Metastatic Head and Neck Cancer", "Recurrent Head and Neck Cancer"]

protocolSection.statusModule.lastUpdatePostDateStruct.date

"2026-04-15"

protocolSection.identificationModule.nctId

"NCT04534205"

protocolSection.identificationModule.officialTitle

"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"

protocolSection.statusModule.overallStatus

"RECRUITING"

protocolSection.designModule.phases

["PHASE2", "PHASE3"]

protocolSection.statusModule.resultsFirstPostDateStruct.date

""

Study condition terms

• Unresectable Head and Neck Squamous Cell Carcinoma (protocolSection.conditionsModule.conditions)
• Metastatic Head and Neck Cancer (protocolSection.conditionsModule.conditions)
• Recurrent Head and Neck Cancer (protocolSection.conditionsModule.conditions)

Intervention details are not present in the imported fields for this record. No drug-condition relationship is inferred from co-listing.

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