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TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

NCT04701476 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-04-16

No results posted yet for this 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.

Conditions

  • Colorectal Cancer; Lung Cancer

Interventions

DRUG

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.

DRUG

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.

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Ray Lee · Teclison Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2027-03-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04701476 on ClinicalTrials.gov