drugset / Trial / NCT06727565
Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01
RandomizedParallel-groupOpen-labelTreatment
Summary
Master protocol: The main goal of this master clinical study is to evaluate the efficacy and safety of multiple novel combination therapies in participants with head and neck squamous cell carcinoma (HNSCC) in various substudies. Substudy-01 will evaluate the efficacy and safety of novel combination of treatment regimens, domvanalimab (DOM) and zimberelimab (ZIM) combined with chemotherapy vs ZIM combined with chemotherapy. The primary objective is to assess the efficacy of DOM and ZIM in combination with chemotherapy versus ZIM in combination with chemotherapy.
Timeline
- Start
- 2025-02-18
- Primary completion
- 2026-08
- Completion
- 2026-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Domvanalimab | Monoclonal antibody | — | Intravenous |
| Background | Carboplatin | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Zimberelimab | Monoclonal antibody | — | Intravenous |