Safety, feasibility and pharmacodynamic activity of intratumoral injections of the agonist anti-CD137 (4-1BB) mAb urelumab in combination with nivolumab

Intravenous dosing of the anti-CD137 (4-1BB) agonist monoclonal antibody urelumab is limited to 8 mg flat doses due to liver toxicity, thus reducing bioavailability. Here we explored intratumoral delivery of urelumab to increase bioavailability at the tumor, while reducing systemic exposure, in combination with systemic nivolumab (clinical trial INTRUST, NCT03792724). Overall design: Bulk RNA-seq of biopsy samples from clinical trial patients at different timepoints.