drugset / Trial / NCT04428047

Evaluation of Bintrafusp Alfa in Operable and Untreated Head and Neck Squamous Cell Carcinoma

NCT04428047

Phase 2 Terminated 7 enrolled UNICANCER Merck KGaA, Darmstadt, Germany · collab
NaSingle-groupOpen-labelTreatment

Summary

This study is a prospective open label, multicenter, phase II, window-of-opportunity preoperative, single-agent trial. This study aims to evaluate the efficacy, the safety and tolerability profile of bintrafusp alfa in patients with histologically or cytologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, previously untreated, with indication of primary surgery. Patients with a diagnosis of head and neck squamous cell carcinoma (HNSCC) from unknown primary will not be enrolled.

Timeline

Start
2021-02-04
Primary completion
2021-09-04
Completion
2022-01-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bintrafusp alfa Protein / enzyme biologic 1200 mg Intravenous