A Study of Dostarlimab vs Placebo After Chemoradiation in Adult Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma (JADE)

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 Carcinoma)

Intervention / Treatment 

  • DrugDostarlimab
  • DrugPlacebo

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 tissue 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 Oncology Group (ECOG) performance status of 0 or 1
  • Has adequate organ function.

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