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RECRUITING
NCT04701476
PHASE2

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Sponsor: Teclison Ltd.

View on ClinicalTrials.gov

Summary

Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.

Official title: An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2021-05-20

Completion Date

2025-12-31

Last Updated

2024-11-22

Healthy Volunteers

No

Interventions

DRUG

TATE and pembrolizumab

All liver metastatic lesions will be treated with TATE for maximally debulking. Pembrolizumab IV infusion per standard schedule every 3 or 6 weeks until progression or maximally 2 years.

DRUG

TAS-102 pill

The comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.

DRUG

Regorafenib Pill

As an alternative to TAS-102 per treating physician's discretion. If selected, Regorafenib 160 mg oral daily for 3 weeks on and one week off, every 4 weeks per cycle. Do not take Regoarefnib if taking TAS-102.

Locations (3)

University of California, Irvine Medical Center

Orange, California, United States

China Medical University Hsinchu Hospital

Hsinchu, Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan