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Clinical Trial Summary

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


Clinical Trial Description

This is a multicenter, single arm, safety lead-in, Phase 2 study, using Simon's 2 stage design evaluating the safety and efficacy of TAS-102 plus nivolumab in participants with Microsatellite-stable refractory metastatic colorectal cancer Stage 1: Participants will be enrolled and after Cycle 1 treatment, they will be evaluated for the safety and tolerability of the combination therapy. Assuming a tolerated dose is confirmed additional participants evaluable for response will be enrolled and followed for a minimum of 6 months and there will be an interim analysis to assess the safety and efficacy to determine whether the second stage will open for enrollment. Stage 2: Additional participant evaluable for response assessment will be enrolled and followed for a minimum of 6 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02860546
Study type Interventional
Source Taiho Oncology, Inc.
Contact
Status Completed
Phase Phase 2
Start date August 29, 2016
Completion date September 7, 2017

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