Ficerafusp Alfa + Pembrolizumab for Head and Neck Cancer
(FORTIFI-FLEX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
The study aims to demonstrate that the antitumor activity of an alternative dosing regimen of ficerafusp alfa in combination with pembrolizumab is comparable to the weekly ficerafusp alfa regimen in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).
Are You a Good Fit for This Trial?
This trial is for adults with head and neck squamous cell carcinoma that has come back or spread, who have not received prior treatment for advanced disease and whose tumors test positive for PD-L1. Participants should be in generally good health.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Ficerafusp alfa
- Pembrolizumab
Trial Overview
The study compares two ways of giving ficerafusp alfa (a drug targeting EGFR and TGF-β) combined with pembrolizumab. One group gets weekly doses; the other gets an alternative dosing schedule to see if both work equally well against cancer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Continuous ficerafusp alfa 1500 mg QW (standard dose) + pembrolizumab 200 mg Q3W.
Loading phase (12 weeks): Ficerafusp alfa 1500 mg QW (standard dose) + pembrolizumab 200 mg Q3W. Maintenance phase: Ficerafusp alfa 2250 mg Q3W (alternative dose) + pembrolizumab 200 mg Q3W.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bicara Therapeutics
Lead Sponsor
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