NCT02860546

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Taiho Oncology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Refractory Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	TAS-102	One Arm Only (of TAS 102 plus nivolumab)
DRUG	nivolumab	One Arm Only (of TAS 102 plus nivolumab)

Timeline

• Start date: 2016-08-29
• Primary completion: 2017-08-01
• Completion: 2017-09-07
• First posted: 2016-08-09
• Last updated: 2024-09-03
• Results posted: 2021-07-26

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study