Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β).
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).
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
Pembrolizumab (KEYTRUDA®)
DrugImmunotherapy agent used in combination with investigational agent
Placebo
DrugPlacebo Control
Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation.
To assess safety and tolerability of ficerafusp alfa with pembrolizumab.
Phase 2 - Objective Response Rate (ORR) per RECIST 1.1 by blinded independent central review (BICR)
ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.
ORR is defined as the proportion of subjects in the DDS who have a confirmed CR or PR per RECIST 1.1. by BICR.
Phase 3 - Overall Survival (OS)
OS: Defined as the time from the randomization to death due to any cause.
Phase 2 - Duration of Response (DOR) per RECIST 1.1 by BICR.
DOR: For subjects who demonstrated CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death, whichever occurs first, 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.
To assess safety and tolerability of ficerafusp alfa with pembrolizumab.
Phase 3 - Progression-free survival (PFS) per RECIST 1.1 by BICR.
PFS: Defined as the time from randomization to the first documented PD per RECIST 1.1 as determined by BICR or death due to any cause, whichever occurs first.
Phase 3 - Objective Response Rate (ORR) per RECIST 1.1 by BICR.
ORR: Defined as confirmed CR + PR per RECIST 1.1 by BICR. (FAS).
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