drugset

drugset / Trial / NCT03406871

Regorafenib and Nivolumab Simultaneous Combination Therapy

NCT03406871 ↗

Phase 1 Completed 50 enrolled Kohei Shitara Bayer Yakuhin, Ltd. · collab Ono Pharmaceutical Co., Ltd. · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

the efficacy and safety ofhe use of regorafenib in combination with nivolumab

Timeline

Start: 2018-01-15
Primary completion: 2020-12-15
Completion: 2020-12-15

Publications

Fukuoka S, Hara H, Takahashi N, Kojima T, Kawazoe A, Asayama M, Yoshii T, Kotani D, Tamura H, Mikamoto Y, Hirano N, Wakabayashi M, Nomura S, Sato A, Kuwata T, Togashi Y, Nishikawa H, Shitara K. Regorafenib Plus Nivolumab in Patients With Advanced Gastric or Colorectal Cancer: An Open-Label, Dose-Escalation, and Dose-Expansion Phase Ib Trial (REGONIVO, EPOC1603). J Clin Oncol. 2020 Jun 20;38(18):2053-2061. doi: 10.1200/JCO.19.03296. Epub 2020 Apr 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Comparator	Regorafenib	Small molecule	80 mg	Oral
Comparator	Regorafenib	Small molecule	120 mg	Oral
Comparator	Regorafenib	Small molecule	160 mg	Oral

Indications

No indication recorded.