A Study Evaluating TAS-102 Plus Nivolumab in Patients With MSS CRC

Phase 2 Completed 18 enrolled Taiho Oncology, Inc.

NaSingle-groupOpen-labelTreatment

Summary

A Phase 2 Study with Safety Lead-in, Evaluating TAS-102 Plus Nivolumab in Participants with Microsatellite Stable Refractory Metastatic Colorectal Cancer

Timeline

Start: 2016-08-29
Primary completion: 2017-08
Completion: 2017-09-07

Outcome

Missed primary endpoint

paper No patient achieved a tumor response (either per Response Evaluation Criteria in Solid Tumors [RECIST] or irRC) PMID 33544407 ↗

Publications

Patel MR, Falchook GS, Hamada K, Makris L, Bendell JC. A phase 2 trial of trifluridine/tipiracil plus nivolumab in patients with heavily pretreated microsatellite-stable metastatic colorectal cancer. Cancer Med. 2021 Feb;10(4):1183-1190. doi: 10.1002/cam4.3630. Epub 2021 Feb 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nivolumab	Monoclonal antibody	3 mg/kg	Intravenous
Subject	TAS-102	Small molecule	35 mg/m2	Oral