drugset / Trial / NCT05459129

A Study Evaluating Efficacy and Safety of Multiple Treatment Combinations in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck (Morpheus-Head and Neck Cancer)

NCT05459129

Phase 1/2 Completed 12 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase Ib/II, open-label, multicenter, randomized, umbrella study in participants with locally advanced squamous cell carcinoma of the head and neck (SCCHN). The study will enroll treatment-naive participants with resectable Stage III-IVA human papillomavirus (HPV)-negative, programmed death-ligand 1 (PD-L1)-positive SCCHN with measurable disease, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) who have not received systemic treatment for their disease.

Timeline

Start
2023-04-12
Primary completion
2024-08-15
Completion
2024-08-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Paclitaxel Small molecule 175 mg/m2 Intravenous
Subject Tiragolumab Monoclonal antibody 600 mg Intravenous