FORTIFI-HN01: A Study of Ficerafusp Alfa with Pembrolizumab for Head and Neck Cancer
This study is testing a new investigational drug called ficerafusp alfa in combination with pembrolizumab (KEYTRUDA®) for people with recurrent (cancer that has come back) or metastatic (cancer that has spread) head and neck squamous cell carcinoma (HNSCC). Ficerafusp alfa works by targeting two proteins, EGFR and TGF-β, which are involved in cancer growth. You may be eligible if you are 18 or older with confirmed HNSCC that is PD-L1-positive. The study aims to see how safe and effective ficerafusp alfa is, looking at side effects and how many people respond to the treatment. The study plans to enroll 650 participants.
- Study design
- This is an interventional study that will compare ficerafusp alfa plus pembrolizumab to a placebo plus pembrolizumab. It has a Phase 2 part to find the best dose and a Phase 3 part to confirm effectiveness.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for side effects for up to 30 days after treatment ends (90 days for serious side effects). Response to treatment will be measured for approximately 1 to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06788990
FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Recruiting
PHASE2Ages 18+InterventionalTreatmentBicara Therapeutics
~650 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:Ficerafusp alfaPembrolizumab (KEYTRUDA®)Placebo
At a glance
Recruiting sites
203 of 203 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.
Measured over Up to 30 days post end of treatment for TEAEs (90 days for SAEs).
+3 more outcomes measured
Conditions
Where it's being run
203 sites across 56 statesItaly17
Germany15
United Kingdom14
Brazil12
France11
Spain11
Portugal8
Poland7
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥18 years on the day the Informed Consent Form is signed.
Histologically or cytologically confirmed R or M HNSCC. Eligible primary tumor locations are oral cavity, hypopharynx, larynx or oropharynx (with documented HPV-negative disease if presenting with OPSCC). Note: primary tumor location of paranasal sinuses and nasopharynx, any histology are excluded.
No prior systemic therapy administered in the R or M setting; and completed systemic therapy \>6 months prior if given as part of multimodal treatment for locoregionally advanced disease in the adjuvant or definitive setting.
Archival tumor tissue or willing to undergo pretreatment biopsy at Screening if archival tissue is insufficient or unavailable.
PD-L1 CPS ≥1.
Measurable disease based on RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function, as defined in the protocol.
Exclusion
Disease suitable for local therapy administered with curative intent.
Prior treatment with anti-TGFβ therapy.
Prior therapy with an anti-EGFR antibody (exception: radio sensitizing agents and multimodal treatment for locoregionally advanced disease).
Prior history of Grade ≥2 intolerance or hypersensitivity reaction to anti-EGFR therapy or other murine proteins.
Prior therapy with an immune checkpoint inhibitor completed within 6 months prior to study treatment initiation.
Progressive disease \<6 months from completion of curative intent systemic therapy for locoregionally advanced HNSCC.
Life expectancy less than 3 months.
Known active central nervous system metastases, history of spinal cord compression from tumor involvement, a history of carcinomatous meningitis, or leptomeningeal disease are excluded.
Current active major bleeding, or a recent major bleeding episode within 4 weeks prior to enrollment.
Subject participated in another clinical study or received treatment with another investigational drug must wait at least 5 half-lives of the treatment received or 4 weeks (whichever is shorter) following prior therapy.
Active autoimmune disease requiring systemic treatment in the past 2 years.
Subjects with chronic hepatitis B virus (HBV) infection with active disease who meet the criteria for anti-HBV therapy and are not on a suppressive antiviral therapy prior to initiation of study treatment.
Subjects with a known history of hepatitis C virus (HCV) who have not completed curative antiviral treatment or have an HCV viral load above the limit of quantification at Screening.
Known history of human immunodeficiency virus (HIV).
Receipt of any organ transplantation, including autologous and allogeneic stem cell transplantation, with the exception of transplants that do not require immunosuppression.
Known to be diagnosed and/or treated for any other additional malignancy within 2 years prior to randomization with the exception of the following: curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, and curatively resected in situ cervical cancer, and curatively resected in situ breast cancer, and low-risk early stage prostate cancer.
Any condition requiring systemic treatment with either corticosteroids (\>10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 7 days prior to the first dose of study treatment, except for topical, intranasal, intrabronchial, or ocular steroids.
Use of a live or live attenuated vaccine within 4 weeks prior to Screening.
What this trial measures
- Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.Up to 30 days post end of treatment for TEAEs (90 days for SAEs).
To assess safety and tolerability of ficerafusp alfa with pembrolizumab.
- Phase 2 - Objective Response Rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)Approximately 1 year.
ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
- Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.Approximately 2 years.
ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
- Phase 3 - Overall Survival (OS)Approximately 3 years.
OS: Defined as the time from the randomization to death due to any cause.