NCT04701476PHASE2Recruiting

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Teclison Ltd.

Start Date

5/20/2021

Completion Date

9/30/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

TATE and pembrolizumab

DRUG

TAS-102 pill

DRUG

Regorafenib Pill

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Conditions

Colorectal Cancer; Lung Cancer

Locations

University of California, Irvine Medical Center

Orange, California 92868

United States

China Medical University Hsinchu Hospital

Hsinchu,

Taiwan

Chung Shan Medical University Hospital

Taichung,

Taiwan