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Clinical trialNCT07552558Not, yet, recruitingPhase 1/PHASE2Interventional

Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

SponsorWashington University School of MedicineEnrollment45HPV-Negative Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The study is an open-label phase I/II clinical trial. The study will enroll patients to receive neoadjuvant SBRT plus 1 or 2 doses of neoadjuvant pembrolizumab with concurrent ficerafusp alfa (4 doses) prior to definitive surgical resection for high-risk, locoregionally advanced HPV-negative head and neck squamous cell carcinoma (HNSCC). Approximately 6 weeks after end of SBRT, patients will undergo standard of care (SOC) surgical resection followed by SOC adjuvant chemoradiation per National Comprehensive Cancer Network (NCCN) guidelines. Adjuvant therapy is not part of this study and therefore is not dictated by study protocol.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Washington University School of Medicine

    St Louis, Missouri, United States

    Anthony J Apicelli, MD, PhDBrendan J Knapp, MDChristine Auberle, MDDaniel Miller, MD, PhDDouglas R Adkins, MDEsther Lu, PhDGregory R Vlacich, MD, PhDHiram Gay, MDJason T Rich, MDJennifer De Los Santos, MDJesse Zaretsky, MD, PhDLannis Hall, MD, MPHNikhil Rammohan, MD, PhDPatrick Pipkorn, MDPaul Zolkind, MDPeter Oppelt, MDR Alex Harbison, MD, MSRobert D Siegel, MDRyan S Jackson, MDSana Karam, MD, PhDSidharth Puram, MD, PhDWade L Thorstad, MDYao Hao, PhD

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Ficerafusp alfaPembrolizumab →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2026
Primary completion
30 Nov 2028
Completion
30 Nov 2033
Last update posted
13 Aug 2026
Registered enrollment
45
Registry id
NCT07552558
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.