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.
University of Chicago
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have history of histologically confirmed squamous cell carcinoma of the oropharynx. * Must be HPV positive; testing must be compliant with meeting any one or more of the following criteria: * p16 IHC positivity (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al.37). * HPV PCR positivity. * HPV in situ hybridization (ISH) positivity. * Completed curative intent therapy. Acceptable curative intent therapies may include any combination of surgery, radiotherapy, and/or chemotherapy is eligible. Curative intent therapy must be completed at l…