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NCT Number: NCT04701476

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

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

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Key information

Conditions

Colorectal Cancer; Lung Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

China Medical University Hsinchu Hospital, Hsinchu, Taiwan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TATE and pembrolizumab

Drug

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.

Other names: TATE: Trans-arterial Tirapazamine Embolization;

TAS-102 pill

Drug

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

Other names: LONSURF

Regorafenib Pill

Drug

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.

Other names: STIVARGA

Primary outcomes

  1. Overall Survival for the mCRC cohort

    Time frame: 24 months

    From the first day of treatment to death

  2. Overall Response Rate (ORR) for the NSCLC cohort

    Time frame: within 24 months

    Per RECIST 1.1 criteria

Secondary outcomes

  1. Duration of Response

    Time frame: 24 months

    per RECIST 1.1

  2. Response rate

    Time frame: 24 months

    in TATE treated or TATE-untreated lesions by RECIST and mRECIST

  3. PFS

    Time frame: 24 months

    Progression Free Survival

  4. TTP

    Time frame: 24 months

    Time to Progression

Study contacts

Contact information is provided by the study sponsor or research team.

Chiwei Lu

CONTACT

[email protected]

Ray Lee, MD. PhD.

CONTACT

[email protected]

8043341076

Sponsors and collaborators

Lead sponsor

Teclison Ltd.

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2021
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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