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

NCT07552558 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-04-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

Hypofractionated Stereotactic Body Radiotherapy (SBRT)

1-3 fractions given over 1 week as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II

BIOLOGICAL

Pembrolizumab

200 mg intravenously (IV) given on Day 1 or Days 1 and 22 as assigned in phase I and as determined to be the maximum tolerated dose (MTD) in phase II.

DRUG

Ficerafusp alfa

750mg intravenously (IV) on Days 1, 8, 15, and 22.

Sponsors & Collaborators

  • Bicara Therapeutics

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Sana Karam, MD, PhD · Washington University School of Medicine

  • Sidharth Puram, MD, PhD · Washington University School of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-08-31
Completion
2033-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07552558 on ClinicalTrials.gov