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A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Treatment

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 1, 2026 to Jun 9, 2026
    v4
  2. Notable Start date: Jan 1, 2026 to Dec 1, 2026v3
  3. Minor Re-verified, no change to tracked fieldsv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if the combination of cemiplimab and fianlimab can improve outcomes compared to cemiplimab alone in adults with Human Papillomavirus Positive HPV-positive head and neck cancer who have detectable minimal-residual disease after definitive treatment. The main question(s) it aims to answer are: * Does combining cemiplimab with fianlimab provide better results in preventing cancer recurrence than cemiplimab alone? * Is the combination treatment safe and well-tolerated by patients? Researchers will compare the group receiving cemiplimab alone to the group receiving the combination of cemiplimab and fianlimab to see if the combination leads to improved treatment outcomes, such as better disease control and longer survival. Participants will: * Receive either cemiplimab alone or a combination of cemiplimab and fianlimab. * Attend regular follow-up visits for monitoring of treatment efficacy and side effects. * Undergo assessments to measure disease progression and response to treatment.
Trial Details
NCT Number NCT07179315
Lead Sponsor University of Chicago
Conditions
(from sponsor)
Head and Neck Cancer
Related terms Head and Neck Neoplasms
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov