RecruitingPhase 2NCT04701476

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

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


Sponsor

Teclison Ltd.

Enrollment

110 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two treatments — TATE (a type of liver-directed therapy) and pembrolizumab (an immunotherapy drug) — for patients with colorectal cancer that has spread to the liver (MSS subtype) or non-small cell lung cancer that has stopped responding to standard therapy. **You may be eligible if...** - You have metastatic colorectal cancer (MSS type) that has spread to the liver and progressed on at least 2 prior chemotherapy regimens, OR non-small cell lung cancer that has progressed on chemotherapy and immunotherapy - Your cancer is measurable on imaging - Your general health is good (ECOG 0-1) - It has been at least 4 weeks since your last chemotherapy **You may NOT be eligible if...** - You have had a prior organ transplant - More than 50% of your liver is involved with cancer - Your oxygen levels are low (below 92% in room air) - You have significant heart or autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTATE 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.

DRUGTAS-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.

DRUGRegorafenib 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

View Full Details on ClinicalTrials.gov

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NCT04701476