Immunotherapy and Nodal-Sparing Irradiation for T-Cell Induction and Unmasking of Tumor Antigenicity in the Microenvironment for Head and Neck Cancer

Study acronym: INITIUM
StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Recruitment opened
    • Start date changed from estimate of Oct 2026 to Oct 8, 2026
    • Eligibility criteria expanded, about 18 words
    • Site details revised
  2. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
This is a non-comparative randomized Phase 2 study using the INITIUM regimen with or without elective nodal irradiation (ENI) delivered before surgery for resectable head and neck squamous cell carcinoma (HNSCC).
Trial Details
NCT Number NCT07773987
Lead Sponsor Medical College of Wisconsin
Conditions
(from sponsor)		 Head and Neck Cancer Squamous Cell Carcinoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov