NCT 06256588
Brief Summary
The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with HNSCC (Head and Neck Squamous Cell Carcinomacancer arising from tissues that line organs)
Intervention / Treatment
- Drug: Dostarlimab
- Drug: Placebo
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
- Has newly diagnosed unresected LA histologically confirmed HNSCC of the oral cavity, oropharynx, hypopharynx or larynx and completed cisplatin plus radiotherapy (termed “CRT” in this protocol) with curative intent and has no evidence of distant metastatic disease.
- Has provided acceptable core or excisional tissuea group of cells that work together to perform a function demonstrating:
- PD-L1 positive tumor status
- If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 IHC testing.
- Has an Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0 or 1
- Has adequate organ function.