Actively Recruiting
Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable Squamous Cell Carcinoma of the Head and Neck: a Phase 2 Trial
Led by Dana-Farber Cancer Institute · Updated on 2026-03-27
32
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
B
Bicara Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of ficerafusp alfa combined with pembrolizumab before surgery in people with resectable, high-risk, locally advanced, PD-L1-positive squamous cell carcinoma of the head and neck (HNSCC). This phase 2, open-label trial focuses on this specific cancer type to better understand treatment responses prior to surgical removal of tumors. The trial is supported by Bicara Therapeutics and led by Dana-Farber Cancer Institute. Participants will receive two cycles of treatment over 42 days. In the first cycle, pembrolizumab is given on day 1, and ficerafusp alfa is administered on days 1, 8, and 15. The second cycle includes both drugs given on day 1. After completing these cycles, participants will undergo standard surgical removal of their tumors. Following surgery, they will have an end-of-treatment visit and will be monitored for up to two years. Throughout the study, participants attend clinic visits for screening, treatment, surgery, and follow-up. They will have blood and urine tests, tumor biopsies, and imaging scans such as CT, MRI, or PET to assess their condition. Researchers will measure treatment response at surgery, track event-free and overall survival every three months for two years, and evaluate safety and other health outcomes. Participants are closely monitored to understand how well the treatments work and their side effects over time.
CONDITIONS
Brief Title
Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed, untreated, locoregionally advanced head and neck squamous cell carcinoma (HNSCC) from oral cavity, oropharynx (HPV-negative if oropharyngeal), larynx, or hypopharynx.
- Resectable disease at baseline as determined by surgical oncologist.
- Clinical stage III or IVA/IVB as defined by AJCC 8th edition TNM staging (T1-2 N1-3, T3 any N, T4 any N).
- Tumor PD-L1 positive with CPS score of 1 or greater.
- Willing to provide blood and tumor tissue samples before treatment and at surgery.
- Age 18 years or older.
- ECOG performance status of 0 or 1.
- Adequate organ and marrow function as defined by blood counts and liver/kidney tests.
- Negative pregnancy test for females of childbearing potential before study and treatment.
- Agree to use effective contraception during and after treatment as specified.
- Ability to understand and sign informed consent.
You will not qualify if you...
- Recurrent, metastatic, or very early-stage (I or II) HNSCC or head and neck cancers from other primary sites like skin, sinuses, nasal cavity, or salivary glands.
- HPV-associated oropharyngeal cancer.
- Inoperable or unresectable disease at baseline.
- ECOG performance status 2 or greater.
- Prior anti-EGFR antibody or anti-PD-1 immunotherapy.
- Significant bleeding risk or recent major bleeding episode.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- Active systemic infection requiring hospitalization or IV antibiotics within 2 weeks before treatment.
- Psychiatric, behavioral, or substance abuse disorders interfering with study compliance.
- Active hepatitis B or C infection not controlled by treatment.
- Known HIV infection.
- History of organ transplantation requiring immunosuppression.
- Other recent malignancies within 2 years except specified low-risk cancers.
- Use of systemic corticosteroids or immunosuppressive drugs within 7 days before treatment, except specified exceptions.
- Use of live vaccines within 4 weeks before screening.
- Active pregnancy or breastfeeding.
- Unwillingness to provide tumor or blood samples for research.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks (2 cycles of 21 days each)
Participants receive neoadjuvant treatment with ficerafusp alfa and pembrolizumab prior to surgery.
Multiple visits on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycle 2 for drug infusions
Duration - 1 day
Participants undergo standard of care surgical resection of the tumor.
1 visit (in-person) for surgical procedure
Duration - Up to 2 years
Participants are monitored for safety and disease status after surgery and treatment for up to 2 years.
Visits every 3 months for up to 24 months
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
G
Glenn Hanna
G
Glenn Hanna
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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