Study design
toxicity, Toxicity
This Phase 2, open-label, single-arm study (516-002 trial; clinicaltrials.gov identifier: NCT03680521) included two sequential preoperative treatment segments (Fig. Sitravatinib was administered orally once daily (QD) at the starting dose of 120 mg. The modified Toxicity Probability Interval (mTPI) method was used to set rules on a dose de-escalation plan to monitor and limit toxicity of the starting dose of sitravatinib in the combination regimen in the neoadjuvant setting