Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2021-05-20
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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colorectal cancer
metastatic colorectal cancer progressed on at least two lines of chemotherapy
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.
NSCLC
Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Teclison Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ray Lee
Role: STUDY_DIRECTOR
Teclison Limited
Locations
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University of California, Irvine Medical Center
Orange, California, United States
China Medical University Hsinchu Hospital
Hsinchu, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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KEYNOTE-A91
Identifier Type: OTHER
Identifier Source: secondary_id
LT-007
Identifier Type: -
Identifier Source: org_study_id
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