Evaluating ficerafusp alfa with pembrolizumab for advanced head and neck cancer

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 study evaluates the safety and efficacy of ficerafusp alfa, a dual-targeting agent, in combination with pembrolizumab for patients with PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The trial consists of two phases: Phase 2 focuses on determining the optimal biologic dose of ficerafusp alfa, while Phase 3 compares the efficacy of the selected dose against a placebo. Participants will be randomized into treatment arms receiving either ficerafusp alfa or placebo alongside pembrolizumab. The study aims to provide insights into a novel therapeutic approach for this challenging cancer type.

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.

Other Inclusion/Exclusion criteria may apply as defined in the protocol.

Where it's running

• University of Alabama Hospital (Site # 0137)
  Birmingham, Alabama, United States Recruiting
• Mayo Clinic Hospital (Site #0147)
  Phoenix, Arizona, United States Recruiting
• UC San Diego Moores Cancer Center (Site #0107)
  La Jolla, California, United States Recruiting
• UCLA Department of Medicine - Hematology/Oncology (Site #0106)
  Los Angeles, California, United States Recruiting
• UC Davis (Site#0144)
  Sacramento, California, United States Recruiting
• University of California San Francisco (Site #0130)
  San Francisco, California, United States Recruiting

+181 more sites. See ClinicalTrials.gov for the full list.

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.

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

  This study tests whether a different dosing approach of ficerafusp alfa plus pembrolizumab works as well as the standard weekly dosing in adults with newly diagnosed or recurrent/metastatic PD-L1-positive head and neck cancer.

  Recruiting at 7 sites Phase 2 Bicara Therapeutics · Fort Myers, Florida and 6 other locations · NCT07807163

• Autologous tumor membrane vesicle (TMV) vaccine alone or with pembrolizumab for recurrent or metastatic head and neck squamous cell carcinoma

  This trial tests whether a vaccine made from a patient's own tumor (TMV), given alone or with pembrolizumab, can help people with recurrent or metastatic head and neck squamous cell carcinoma who had tumor tissue banked at surgery.

  Recruiting at 2 sites Phase 1 Emory University · Atlanta, Georgia and 1 other locations · NCT06868433

• Combining lovastatin and pembrolizumab for advanced head and neck cancer treatment

  This study is testing if combining a cholesterol-lowering drug called lovastatin with an immunotherapy drug called pembrolizumab can help people with advanced head and neck cancer feel better and live longer.

  Recruiting at 2 sites Phase 2 Emory University · Atlanta, Georgia and 1 other locations · NCT06636734

• Combining cetuximab with pembrolizumab for advanced head and neck cancer

  This study is testing if adding cetuximab to pembrolizumab can help people with advanced head and neck cancer live longer and feel better compared to just using pembrolizumab alone.

  Recruiting at 192 sites Phase 3 National Cancer Institute (NCI) · Little Rock, Arkansas and 201 other locations · NCT06589804

• Morning versus afternoon immunotherapy for advanced or metastatic solid tumors

  This trial tests whether giving standard immune checkpoint inhibitor therapy in the morning versus the afternoon changes outcomes for adults with advanced or metastatic solid tumors.

  Recruiting Phase 4 OHSU Knight Cancer Institute · Portland, Oregon · NCT07405086

• Re‑radiation with chemotherapy plus pembrolizumab versus pembrolizumab (± chemotherapy) for recurrent PD‑L1 positive head and neck cancer

  This trial tests whether adding re‑radiation with chemotherapy followed by pembrolizumab helps people with PD‑L1 positive (CPS≥1) locoregionally recurrent head and neck cancer live longer than pembrolizumab alone (with or without chemotherapy).

  Recruiting at 20 sites Phase 3 Universität des Saarlandes · Berlin and 23 other locations · NCT07026474

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.