Apatinib With Pembrolizumab in Previously Treated Advanced Malignancies

Summary

This is an open label nonrandomized Phase I/ IIA trial designed to assess the safety, tolerability, and efficacy of apatinib in combination with pembrolizumab. Phase I will assess the safety of combining increasing oral daily doses of apatinib with a fixed dose of IV pembrolizumab every three weeks and will determine the RP2D (Recommended Phase 2 Dose). Phase II will assess the efficacy of the RP2D of apatinib in combination with pembrolizumab and provide additional safety and tolerability data in three disease-specific cohorts

Timeline

Start

2018-06-19

Primary completion

2019-08-19

Completion

2020-07-02

Publications

• Gumbleton M, Allan S, Conway H, Boucher K, Marvin J, Hawks J, Burnett W, Van Brocklin M, Whisenant J, Gilcrease G, Gupta S. A phase I open-label study of the safety and efficacy of apatinib (rivoceranib) administered to patients with advanced malignancies to improve sensitivity to pembrolizumab in the second- or later-line setting (APPEASE). BMC Res Notes. 2023 Feb 16;16(1):16. doi: 10.1186/s13104-023-06283-5.

Drugs

Indications