Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04701476 | RECRUITING | Colorectal Cancer; Lung Cancer

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC
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.

Condition or disease

Colorectal Cancer; Lung Cancer

Intervention/treatment

TATE and pembrolizumab

TAS-102 pill

Regorafenib Pill

Phase

PHASE2

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 Type : INTERVENTIONAL
Estimated Enrollment : 110 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2021-05-20
Estimated Primary Completion Date : 2025-12-30
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Location Details

NCT04701476

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of California, Irvine Medical Center

Orange, California, United States, 92868

RECRUITING

Taiwan,

China Medical University Hsinchu Hospital

H die N places, Taiwan,

RECRUITING

Taiwan,

Chung Shan Medical University Hospital

Taichung, Taiwan,