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)

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)

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Abstract Objective APPEASE is a phase I study to assess the safety, dosing, and efficacy of rivoceranib (a selective, small-molecule inhibitor of VEGFR2) in combination with pembrolizumab.We aimed to treat patients with metastatic malignancies who have progressed through at least first-line therapy, with pembrolizumab 200 mg every 3 weeks, as well as escalating doses of rivoceranib until disease progression or unacceptable toxicity.Results Five patients were enrolled on the starting dose of rivoceranib 300 mg once daily.

There were no dose-limiting toxicities read more observed in combination with pembrolizumab.The dose of rivoceranib was not escalated due to study closure.We note a truvisionhealthftp.com treatment related grade 3 adverse event (AE) rate of 40%, predominantly in urothelial cancer patients, with no deaths related to treatment related AEs.

The disease control rate was 75% (3 of 4) and the median progression free survival (PFS) was 3.6 months.Tumor shrinkage was noted in patients who were previously progressing on pembrolizumab alone.

Apatinib 300 mg is safe and demonstrates anti-tumor activity in advanced solid tumors in combination with pembrolizumab.Further dose escalation and efficacy need to be investigated in larger disease-specific patient populations.Trial registration number: Clinical trial registration number: NCT03407976.

Date of registration: January 17, 2018.