Ficerafusp alfa (BCA101) with pembrolizumab in first-line PD-L1-positive recurrent/metastatic HNSCC: alternative dosing vs weekly dosing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized study evaluating two dosing strategies of ficerafusp alfa in combination with pembrolizumab for first-line PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma. All participants receive ficerafusp alfa 1500 mg weekly with pembrolizumab every 3 weeks for 12 weeks, followed by randomization to either an alternative 2250 mg every 3 weeks or the standard 1500 mg weekly dosing, both with pembrolizumab Q3W. The trial focuses on comparing antitumor activity between the two regimens in patients whose disease is measurable and who have adequate organ function. Eligibility includes adults with histologically confirmed R/M HNSCC, no prior systemic therapy for R/M disease, surgical suitability of tumor specimens for biomarker analysis, PD-L1 CPS ≥1, ECOG 0-1, and adequate organ function. Exclusions include disease amenable to local therapy and other standard contraindications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Site US077
  Fort Myers, Florida, United States Recruiting
• Site US078
  Orlando, Florida, United States Recruiting
• Site US075
  St. Petersburg, Florida, United States Recruiting
• Site US076
  West Palm Beach, Florida, United States Recruiting
• Site US069
  Baton Rouge, Louisiana, United States Recruiting
• Site US074
  Tyler, Texas, United States Recruiting

Study contacts

• Study coordinator: Medical Affairs
• Email: FORTIFI_inquiries@bicara.com
• Phone: 1-617-468-4219

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.