Status:
RECRUITING
TATE and Pembrolizumab (MK3475) in mCRC and NSCLC
Lead Sponsor:
Teclison Ltd.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Colorectal Cancer; Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04701476
Start Date
May 20 2021
End Date
December 31 2025
Last Update
November 22 2024
Active Locations (3)
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1
University of California, Irvine Medical Center
Orange, California, United States, 92868
2
China Medical University Hsinchu Hospital
Hsinchu, Taiwan
3
Chung Shan Medical University Hospital
Taichung, Taiwan