Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07465276
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ficerafusp alfa — DRUG
    Bifunctional antibody and recombinant fusion protein, single-use vial, via intravenous (into the vein) infusion per protocol.
  • Pembrolizumab — DRUG
    Monoclonal antibody, single-dose vial, via intravenous infusion per protocol.

Study Details

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)

Key Dates

Start date
Mar 26, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2030

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ficerafusp Alfa plus Pembrolizumab
    32 participants will be enrolled and will complete: * Baseline visit * Cycle 1 (21 day cycle): * Day 1: predetermined dose of Prembrolizumab 1x daily. * Days 1, 8, and 15: predetermined dose of Ficerafusp Alfa 1x daily. * Cycle 2 (21 day cycle): * Day 1: predetermined dose of Prembrolizumab 1x daily. * Day 1: predetermined dose of Ficerafusp Alfa 1x daily. * Standard of care surgery * End of treatment visit * Follow up for up to 2 years

Primary Outcome Measure

Pathologic Treatment Response-2 (pTR-2) Rate [ Time Frame: Assessed at time of surgical resection, between days 30 and 42 from start of neoadjuvant treatment. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Glenn Hanna
[email protected]
617-632-3779
Dana-Farber Cancer InstituteBostonMassachusetts02215
Glenn Hanna
[email protected]
617-632-3779
Glenn Hanna (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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