ClinicaliQ Trial Snapshot
- A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma — Recruiting • Phase III • Oncology • NCT06256588.
- What is being tested: Dostarlimab (a PD-1 checkpoint inhibitor) versus placebo as maintenance therapy following chemoradiation in patients with locally advanced, unresectable head and neck squamous cell carcinoma, evaluating both safety and efficacy outcomes.
- Patient eligibility overview: Adult patients with locally advanced unresected HNSCC who have completed chemoradiation treatment are eligible; specific criteria regarding performance status, organ function, and prior treatment history would determine final inclusion.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The goal of this study is to assess the safety and effectiveness of Dostarlimab compared to Placebo in adult participants with Head and Neck Squamous Cell Carcinoma (HNSCC)
Eligibility Snapshot
- : Participants are eligible to be included in the study only if all of the following criteria apply: * Has newly diagnosed unresected Locally Advanced (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 biopsy obtained prior to CRT: * PD-L1 positive tumor status * If the primary tumor site is oropharyngeal carcinoma, the participant must have p16 immunohistochemistry (IHC) testing. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Has adequate organ function.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.