– New expansion cohorts to be added to ongoing STELLAR-001 trial following dose-escalation phase –
San Francisco, CA (UroToday.com) — Exelixis, Inc. announced a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer for the ongoing phase 1b dose escalation study STELLAR-001 (previously called “XL092-001”), adding three new cohorts that will evaluate the safety and tolerability of XL092, Exelixis’ novel next-generation tyrosine kinase inhibitor (TKI), in combination with avelumab (BAVENCIO®), an anti-PD-L1 immune checkpoint inhibitor (ICI), in patients with locally advanced or metastatic urothelial carcinoma (UC). Avelumab is being co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer. Exelixis is sponsoring the STELLAR-001 clinical trial, and Merck KGaA, Darmstadt, Germany and Pfizer will provide avelumab for use in the trial.