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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - your organs (liver, kidneys, etc.) are working well enough based on blood tests Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (3)

University of California, Irvine Medical Center
Orange, California, United States
China Medical University Hsinchu Hospital
Hsinchu, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan