FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC
Phase 2/3
650
about 4.5 years
18+
51 sites in AL, AZ, CA +24
What this study is about
Researchers are testing a treatment with ficerafusp alfa and pembrolizumab versus placebo with pembrolizumab for people with recurrent or metastatic head and neck squamous cell carcinoma who have high PD-L1 levels. The trial will last about 1645 days.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Ficerafusp alfa
- 2.Take Pembrolizumab (KEYTRUDA®)
- 3.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
immunotherapy (PD-1 inhibitor immunotherapy (pembrolizumab)), pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion
Primary: Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation., Phase 2 - Objective Response Rate (ORR) per RECIST 1.1 by blinded independent central review (BICR), Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR., Phase 3 - Overall Survival (OS)
Secondary: Phase 2 - Duration of Response (DOR) per RECIST 1.1 by BICR., Phase 3 - 14. Time to deterioration (TTD) in global health status measured by the EORTC QLQ C30 items for global health status and quality of life scale (item 29/30), Phase 3 - DOR, per RECIST 1.1 by investigator's assessment., Phase 3 - Duration of Response (DOR) per RECIST 1.1 by BICR., Phase 3 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation., Phase 3 - ORR, per RECIST 1.1 by investigator's assessment., Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR., Phase 3 - PFS, per RECIST 1.1 by investigator's assessment.
Oncology