TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Colorectal Cancer; Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04701476
• Other study ID #: LT-007
• Secondary ID: KEYNOTE-A91
• Status: Recruiting
• Phase: Phase 2
• Start date: May 20, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Teclison Ltd.
• Contact: Ray Lee, MD. PhD.
• Phone: 8043341076
• Email: ray.lee01[@]teclison.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: December 31, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer; Lung Cancer
• Colorectal Neoplasms
• Lung Neoplasms

Intervention

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.
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Teclison Ltd.	Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival for the mCRC cohort	From the first day of treatment to death	24 months
Primary	Overall Response Rate (ORR) for the NSCLC cohort	Per RECIST 1.1 criteria	within 24 months
Secondary	Duration of Response	per RECIST 1.1	24 months
Secondary	Response rate	in TATE treated or TATE-untreated lesions by RECIST and mRECIST	24 months
Secondary	PFS	Progression Free Survival	24 months
Secondary	TTP	Time to Progression	24 months