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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04701476

Enrollment

110

Registered

2021-01-08

Start date

2021-05-20

Completion date

2027-09-30

Last updated

2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer; Lung Cancer

Keywords

colorectal cancer, NSCLC, pembrolizumab, tirapazamine, Liver metastasis

Brief 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.

Detailed description

This study is an open-label study to treat patients with refractory metastatic colorectal cancer and non-small cell lung cancer with liver metastasis. Patients enrolled in the mCRC cohort will be randomized to receive study treatment Trans-arterial Tirapazamine Embolization (TATE)+Pembrolizumab or FDA-approved standard of care, such as TAS-102 or regorafenib, and their Overall Survival (OS) will be compared in the two cohorts as the primary endpoint. Patients enrolled in the NSCLC cohort will all receive study treatment TATE+Pembrolizaumb and Overall Response Rate (ORR) will be the primary endpoint.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Open-label study in two indications. The mCRC cohort will be a randomized trial for TATE+Pembrolizumab versus standard 3rd line therapy for mCRC. The NSCLC cohort will be single-arm study.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

Measure	Time frame	Description
Duration of Response	24 months	per RECIST 1.1
Response rate	24 months	in TATE treated or TATE-untreated lesions by RECIST and mRECIST
PFS	24 months	Progression Free Survival
TTP	24 months	Time to Progression

Countries

Taiwan, United States

Contacts

CONTACTRay Lee, MD. PhD.

ray.lee01@teclison.com8043341076

CONTACTChiwei Lu

chiwei.lu4@teclison.com

STUDY_DIRECTORRay Lee

Teclison Limited

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026