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).
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.
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.
Parallel
Ficerafusp alfa
Druginvestigational agent
Pembrolizumab (KEYTRUDA®)
Drugimmunotherapy agent used in combination with investigational agent
Proportion of participants in maintenance phase who are progression-free as assessed by blinded independent central review (BICR) per RECIST 1.1 and alive.
Serum exposure of ficerafusp alfa.
Pre- and post-infusion serum concentrations and area under the curve (AUC) for ficerafusp alfa.
Objective response rate (ORR) per RECIST 1.1 by blinded independent central review (BICR).
ORR is defined as the proportion of subjects who have a confirmed CR or PR per RECIST 1.1. by BICR.
Disease control rate (DCR) per RECIST 1.1 by blinded independent central review (BICR)
DCR is defined as the proportion of subjects who have a SD, CR or PR per RECIST 1.1. by BICR
Clinical Benefit Rate (CBR) per RECIST 1.1 by blinded independent central review (BICR)
CBR is defined as the proportion of subjects who demonstrated CR + PR + SD\>6 months per RECIST 1.1 by BICR.
Click on the lead sponsor to view all of their trials.
