FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC (NCT06788990)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-ฮฒ). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
Who can join: Review the eligibility criteria below.
Location: Site # 0137 โ Birmingham, Alabama
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (203 Sites)
Showing the first 25 of 203 sites.
- Site # 0137 โ Birmingham, Alabama
- Site #0147 โ Phoenix, Arizona
- Site #0107 โ La Jolla, California
- Site #0106 โ Los Angeles, California
- Site#0144 โ Sacramento, California
- Site #0130 โ San Francisco, California
- Site #0150 โ Stanford, California
- Site #0122 โ Aurora, Colorado
- Site #0124 โ Aurora, Colorado
- Site#0121 โ Aurora, Colorado
- Site #0148 โ Jacksonville, Florida
- Site #0136 โ Palm Bay, Florida
- Site #0105 โ Tampa, Florida
- Site#0140 โ Iowa City, Iowa
- Site #0149 โ Westwood, Kansas
- Site#0111 โ Louisville, Kentucky
- Site#0115 โ Louisville, Kentucky
- Site #0112 โ Baltimore, Maryland
- Site #0131 โ Boston, Massachusetts
- Site#0101 โ Boston, Massachusetts
- Site #0156 โ Maplewood, Minnesota
- Site #0146 โ Rochester, Minnesota
- Site #0114 โ St Louis, Missouri
- Site #0145 โ Newark, New Jersey
- Site #0155 โ New York, New York
๐ Contact the Study Coordinator
Phone: (617) 468-4219
Email: FORTIFI_inquiries@bicara.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Head and Neck Squamous Cell Carcinoma
- Sorafenib in Combination With Carboplatin and Paclitaxel in Treating Participants With Metastatic or Recurrent Head and Neck Squamous Cell Cancer โ Houston, Texas
- Cetuximab and Recombinant Interleukin-12 in Treating Patients With Squamous Cell Carcinoma of the Head and Neck That is Recurrent, Metastatic, or Cannot Be Removed by Surgery โ Washington D.C., District of Columbia
- Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment โ Little Rock, Arkansas
Explore by condition: All Metastatic Head and Neck Squamous Cell Carcinoma clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.