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Head & NeckOpen to EnrollmentPhase 3

HEAD AND NECK: LOCALLY ADVANCED: POST-CRT: PD-L1 +: JADE

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate Dostarlimab as Sequential Therapy After Chemoradiation in Participants With Locally Advanced Unresected Head and Neck Squamous Cell Carcinoma

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Study snapshot

Title
GlaxoSmithKline 221530 Head and Neck post CRT
Malignancy
Head and Neck cancer, oropharyngeal oropharynx cancer, oral cavity cancer, larynx laryngeal cancer, hypopharynx hypopharyngeal cancer
Stage
Stage 3
Disease setting
Adjuvant, post radiation
Line of therapy
post-CRT
Investigational agent
dostarlimab
Drug class
anti PD-1
Principal investigator
Gary Tian MD, PhD
Sponsor
Glaxo Smith Kline
Path
squamous cell carcinoma
Randomized
No
ClinicalTrials.gov ID
NCT06256588

Eligibility and objectives

Key eligibility criteria details

  • 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.
  • ECOG PS 0-1
  • PD-L1 positive
  • Must not have received prior XRT, systemic therapy, targeted thyerapy, or radical surgery for management of head and neck cancer not considered part of CRT
  • No cirrhosis
  • No prior PD-1/PD-L1 or other immunotherapy

Objective

  • Primary
    • EFS by central review
  • Secondary
    • OS
    • EFS per investigator
    • Safety
    • PK

Treatment details