Inhibrx Biosciences, Inc
This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody ordastobart (INBRX-106) combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with recurrent or metastatic (R/M) HPV-positive Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) expressing PD-L1.
Inclusion Criteria: * Has histologically or cytologically confirmed diagnosis of recurrent/metastatic oropharyngeal squamous cell carcinoma (OPSCC) considered incurable by local therapies. * Has tumor PD-L1 expression with a combined proportion score (CPS) ≥1 by central testing. * HPV-positive tumor status as assessed locally by p16 immunohistochemistry (IHC). * Has measurable disease per RECIST 1.1 guidelines. * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Exclusion Criteria: * Has primary tumor site (any histology) of any other location than oropharynx. *…
INBRX-106 0.1 mg/kg by intravenous (IV) infusion, given every 3 weeks (QW3)
Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)