127TiP PROPEL: A phase I/II trial of bempegaldesleukin (NKTR-214) in combination with pembrolizumab (pembro) in patients (pts) with advanced solid tumours

AbstractBackgroundCheckpoint Inhibitors (CPIs), are now part of standard treatment in many advanced solid tumors, including metastatic non-small cell lung cancer (mNSCLC). However, novel, more effective CPI combinations are needed to broaden, deepen, and prolong responses, especially for pts with poor prognostic features or negative predictive clinical factors for CPI benefit, including PD-L1 negative (-) status. Bempegaldesleukin (BEMPEG; NKTR-214) is a CD122-preferential IL-2 pathway agonist designed to provide sustained signaling through the IL-2 βγ receptor. BEMPEG + CPI has demonstrated promising efficacy and can convert PD-L1(-) tumors to PD-L1(+) in pts with multiple solid tumors (Diab A, ASCO 2018; Siefker-Radtke A, ASCO-GU 2019). Given the early efficacy data and favorable safety profile of BEMPEG + nivolumab, PROPEL will evaluate th e clinical benefit, safety and tolerability of BEMPEG combined with another CPI, pembrolizumab (PEMBRO).Trial DesignThis phase I/II multinational trial evaluates BEMPEG + PEMBRO in pts with locally advanced or metastatic solid tumors. There are two key components to the study: 1) Dose optimization: which includes 3  + 3 and step-up dosing (U.S. enrollment only) and will include ∼40 pts with first- and second-line melanoma, NSCLC, urothelial carcinoma, head and neck squamous cell carcinoma, and hepatocellular carcinoma, regardless of PD-L1 status; 2) Dose expansion: which includes ∼58 first-line mNSCLC pts (enrolling globally). ...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research