TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Phase 2

Recruiting

• Conditions: Colorectal Cancer; Lung Cancer
• Interventions: Drug: TATE and pembrolizumab; Drug: TAS-102 pill; Drug: Regorafenib Pill

• Registration Number: NCT04701476
• Lead Sponsor: Teclison Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-05-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
colorectal cancer	TATE and pembrolizumab	metastatic colorectal cancer progressed on at least two lines of chemotherapy
colorectal cancer	Regorafenib Pill	metastatic colorectal cancer progressed on at least two lines of chemotherapy
NSCLC	TATE and pembrolizumab	Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy
colorectal cancer	TAS-102 pill	metastatic colorectal cancer progressed on at least two lines of chemotherapy

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Duration of Response	24 months	per RECIST 1.1
Response rate	24 months	in TATE treated or TATE-untreated lesions by RECIST and mRECIST
PFS	24 months	Progression Free Survival
TTP	24 months	Time to Progression

Trial Locations

Locations (3)

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan

China Medical University Hsinchu Hospital; 🇨🇳 Hsinchu, Taiwan