RecruitingPhase IIEN originalHead and neck cancer

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Potwierdzony histologicznie rak płaskonabłonkowy gardła (okolicy orofaryngealnej)
  • Dodatni wynik na HPV (potwierdzone testami p16, PCR na HPV lub techniką ISH)
  • Ukończone leczenie celujące na wyleczenie (operacja, radioterapia i/lub chemioterapia) co najmniej 1 miesiąc przed zapisaniem się do badania
  • Wykrywalny ślad wirusa HPV we krwi (ctHPVDNA) potwierdzony badaniem NavDx
  • Zbadany poziom markera PD-L1 w biopsji za pomocą testu immunohistochemicznego
  • Brak widocznych śladów nowotworu w badaniach obrazowych (tomografia, rezonans lub PET) lub wyniki wątpliwe
  • Wiek minimum 18 lat
  • Dobry ogólny stan zdrowia (skala ECOG 0 lub 1, wyjątkowo 2)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 16, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

The University of Chicago

Chicago, United States

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/17/2026.

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