RecruitingPhase 2NCT07179315

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

A Randomized Phase II Trial of Cemiplimab With or Without Fianlimab in Patients With Detectable Minimal-residual Disease After Definitive Treatment for Human Papillomavirus Positive HPV(+) Head and Neck Cancer.


Sponsor

University of Chicago

Enrollment

68 participants

Start Date

Jun 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cemiplimab and a drug called cemiplimab+fianlimab for people with head and neck cancer. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcemiplimab+fianlimab

Fianlimab 1600 mg + Cemiplimab 350 mg FDC

DRUGCemiplimab

350 mg


Locations(1)

The University of Chicago

Chicago, Illinois, United States

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NCT07179315


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