TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

NCT04701476 · tracked via the Priya Life Science USA tracker

Sponsor

Teclison Ltd.

Phase

Phase 2

Started

2021-05-20

Last updated

2026-04-16

Condition(s) studied

Colorectal Cancer; Lung Cancer

Investigational drug(s) / intervention(s)

TATE and pembrolizumabTAS-102 pillRegorafenib Pill

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.

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.

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Liver metastatic MSS-mCRC or NSCLC without EGFR or AKT mutations * mCRC progressed on at least two lines of standard chemotherapy; or * NSCLC progressed on chemotherapy and an immune checkpoint inhibitor * Measurable disease * ECOG 0-1 * At least 4 weeks from prior chemotherapy and free from chemo-related toxicity * Adequate organ function Exclusion Criteria: * Prior organ transplantation * Liver metastasis more than 50% * Oxygen saturation less than 92% in room air * Prior autoimmune disorder * CNS metastasis * Major GI bleeding in the last 2 months

Primary outcome measure(s)

Overall Survival for the mCRC cohort — 24 months
From the first day of treatment to death
Overall Response Rate (ORR) for the NSCLC cohort — within 24 months
Per RECIST 1.1 criteria

Trial sites (3)

Facility	City	Region	Status
University of California, Irvine Medical Center	Orange	California	Recruiting
China Medical University Hsinchu Hospital	Hsinchu	Taiwan	Recruiting
Chung Shan Medical University Hospital	Taichung	Taiwan	Recruiting

More Teclison Ltd. trials in the USA

Combination of TATE and PD-1 Inhibitor in Liver Cancer Recruiting

Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04701476 on ClinicalTrials.gov ↗ ← All trials in the USA