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Clinical Trials in the USA / NCT04701476
Recruiting Phase 2

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 pill →Regorafenib 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
No
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)

FacilityCityRegionStatus
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