FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Public ClinicalTrials.gov record NCT06788990. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Study identification
- NCT ID
- NCT06788990
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- Bicara Therapeutics
- Industry
- Enrollment
- 650 participants
Conditions and interventions
Conditions
Interventions
- Ficerafusp alfa Drug
- Pembrolizumab (KEYTRUDA®) Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 27, 2025
- Primary completion
- Mar 31, 2028
- Completion
- Jun 30, 2029
- Last update posted
- May 13, 2026
2025 – 2029
United States locations
- U.S. sites
- 53
- U.S. states
- 27
- U.S. cities
- 42
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site # 0137 | Birmingham | Alabama | 35233 | Recruiting |
| Site #0147 | Phoenix | Arizona | 85054 | Recruiting |
| Site #0107 | La Jolla | California | 92093 | Recruiting |
| Site #0106 | Los Angeles | California | 90095 | Recruiting |
| Site#0144 | Sacramento | California | 95817 | Recruiting |
| Site #0130 | San Francisco | California | 94143 | Recruiting |
| Site #0150 | Stanford | California | 94305 | Recruiting |
| Site #0122 | Aurora | Colorado | 80012 | Recruiting |
| Site #0124 | Aurora | Colorado | 80045 | Recruiting |
| Site#0121 | Aurora | Colorado | 80045 | Recruiting |
| Site#0127 | Newark | Delaware | 19713 | Recruiting |
| Site #0148 | Jacksonville | Florida | 32224 | Recruiting |
| Site #0136 | Palm Bay | Florida | 32901 | Recruiting |
| Site #0105 | Tampa | Florida | 33612 | Recruiting |
| Site #0133 | Chicago | Illinois | 60064 | Recruiting |
| Site#0140 | Iowa City | Iowa | 52242 | Recruiting |
| Site #0149 | Westwood | Kansas | 66205 | Recruiting |
| Site#0109 | Lexington | Kentucky | 40536 | Recruiting |
| Site#0111 | Louisville | Kentucky | 40202 | Recruiting |
| Site#0115 | Louisville | Kentucky | 40202 | Recruiting |
| Site #0112 | Baltimore | Maryland | 21201 | Recruiting |
| Site #0131 | Boston | Massachusetts | 02114 | Recruiting |
| Site#0101 | Boston | Massachusetts | 02136 | Recruiting |
| Site #0156 | Maplewood | Minnesota | 55109 | Recruiting |
| Site #0146 | Rochester | Minnesota | 55905 | Recruiting |
| Site #0114 | St Louis | Missouri | 63110 | Recruiting |
| Site #0119 | Hackensack | New Jersey | 07601 | Recruiting |
| Site #0145 | Newark | New Jersey | 07103 | Recruiting |
| Site #0155 | New York | New York | 10003 | Recruiting |
| Site#0142 | New York | New York | 10021 | Recruiting |
| Site#0118 | Durham | North Carolina | 27703 | Recruiting |
| Site#0154 | Canton | Ohio | 44708 | Recruiting |
| Site#0117 | Cincinnati | Ohio | 45221 | Recruiting |
| Site #0151 | Cleveland | Ohio | 44106 | Recruiting |
| Site #0108 | Cleveland | Ohio | 44195 | Recruiting |
| Site #0113 | Portland | Oregon | 97213 | Recruiting |
| Site #0103 | Pittsburgh | Pennsylvania | 15206 | Recruiting |
| Site #0123 | Pittsburgh | Pennsylvania | 15240 | Recruiting |
| Site #0132 | Providence | Rhode Island | 02903 | Recruiting |
| Site#0104 | Charleston | South Carolina | 29425 | Recruiting |
| Site#0126 | Nashville | Tennessee | 37203 | Recruiting |
| Site #0116 | Nashville | Tennessee | 37232 | Recruiting |
| Site#0102 | Houston | Texas | 77005 | Recruiting |
| Site #0152 | Waco | Texas | 676712 | Recruiting |
| Site#0134 | Charlottesville | Virginia | 22904 | Recruiting |
| Site #0129 | Richmond | Virginia | 23219 | Recruiting |
| Site #0138 | Richmond | Virginia | 23249 | Recruiting |
| Site # 0160 | Edmonds | Washington | 98026 | Recruiting |
| Site # 0159 | Seattle | Washington | 98104 | Recruiting |
| Site #0125 | Seattle | Washington | 98109 | Recruiting |
| Site#0120 | Vancouver | Washington | 98684 | Recruiting |
| Site #0141 | Madison | Wisconsin | 53705 | Recruiting |
| Site #0157 | Madison | Wisconsin | 53792 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 108 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06788990, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 13, 2026 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06788990 live on ClinicalTrials.gov.