๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-02-27

Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01 (NCT06727565)

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Gilead Sciences

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Siteman Cancer Center โ€” St Louis, Missouri

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

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Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (23 Sites)

  • Siteman Cancer Center โ€” St Louis, Missouri
  • Tennessee Oncology, PLLC - Greco-Hainsworth Centers for Research โ€” Nashville, Tennessee
  • The University of Texas, MD Anderson Cancer Center โ€” Houston, Texas
  • Westmead Hospital โ€” Sydney, New South Wales
  • ICON Cancer Center โ€” Kurralta Park, South Australia
  • Monash Health โ€” Clayton, Victoria
  • Alfred Health โ€” Melbourne, Victoria
  • Sichuan Cancer Hospital โ€” Chengdu,
  • Zhejiang Cancer Hospital โ€” Hangzhou,
  • Guangxi Medical University Cancer Hospital โ€” Nanning,
  • Shanghai East Hospital โ€” Shanghai,
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology โ€” Wuhan,
  • CHU de Bordeaux โ€” Pessac,
  • Fondazione IRCCS Istituto Nazionale dei Tumori โ€” Milan,
  • Istituto Nazionale Tumori Fondazione G. Pascale โ€” Naples,
  • Sarawak General Hospital โ€” Sarawak,
  • Hospital Universitario Virgen del Rocio โ€” Seville,
  • Kaohsiung Medical University Chung-Ho Memorial Hospital โ€” Kaohsiung City,
  • China Medical University Hospital โ€” Taichung,
  • Taipei Veterans General Hospital โ€” Taipei,
  • Chang Gung Memorial Hospital, Linkou โ€” Taoyuan,
  • Barts Health NHS Foundation Trust โ€” London,
  • The Royal Marsden NHS Foundation Trust โ€” London,

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
๐Ÿ›๏ธ View Official NIH Record โ†—