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Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC

NCT07465276 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-03-27

No results posted yet for this study

Summary

This trial is to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab prior to surgical resection in participants with resectable, high-risk, locoregionally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC).

The names of the study drugs used in this research study are:

* ficerafusp alfa (a type of bifunctional antibody and recombinant fusion protein)
* pembrolizumab (a type of monoclonal antibody)

Conditions

  • Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Ficerafusp alfa

Bifunctional antibody and recombinant fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.

DRUG

Pembrolizumab

Monoclonal antibody, single-dose vial, via intravenous infusion per protocol.

Sponsors & Collaborators

Principal Investigators

  • Glenn Hanna · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2028-04-30
Completion
2030-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT07465276 on ClinicalTrials.gov