NCT04988074 Trial of Cemiplimab, or Cemip-Chemo Followed by Biomarker-guided Treatment for Pts w/HPV H&N Ca
| NCT ID | NCT04988074 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | HPV-Related Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2021-12-13 |
| Primary Completion | 2027-06-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
To determine if it is feasible to use neoadjuvant immunotherapy (or immunotherapy plus chemotherapy) to reduce treatment intensity and improve long-term quality of life while maintaining very high cure rates.
Eligibility Criteria
Inclusion Criteria: * Subjects must have pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible. * HPV testing must be compliant with the following criteria: * p16 IHC positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al89). * p16 IHC positivity is to be validated using an HPV nucleic acid based secondary assay (HPV ISH, HPV PCR, HPV cfDNA) before or during the neoadjuvant phase.\* * HPV DNA ISH is acceptable if positive, however a negative HPV DNA ISH should be confirmed by HPV RNA ISH or other nucleic acid based method. * HPV16 type (non-HPV16 related cancers are not eligible)\* * \*In the rare event that a subject starts treatment based on p16 IHC alone and HPV type determination is not yet available, subject may commence neoadjuvant treatment based on p16 IHC alone, as along as HPV nuclei