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TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04701476
Recruitment Status : Recruiting
First Posted : January 8, 2021
Last Update Posted : August 25, 2021
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Teclison Ltd.

Study Description
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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 Intervention/treatment Phase
Colorectal Cancer; Lung Cancer Drug: TATE and pembrolizumab Phase 2

Detailed Description:
This study is an open-label single-arm study to treat patients with refractory metastatic colorectal cancer and non-small cell lung cancer with liver metastasis. Patients' metastatic liver lesions will be treated with Trans-arterial Tirapazamine Embolization (TATE) for maximal tumor debulking along with IV injection of Pembrolizumab every three weeks until disease progression or maximally two years.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, single-arm in two disease indications
Masking: None (Open Label)
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 : May 20, 2021
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: colorectal cancer
metastatic colorectal cancer progressed on at least two lines of chemotherapy
 Drug: TATE and pembrolizumab
All liver metastatic lesions will be treated with TATE for maximally debulking. Pembrolizumab IV infusion every 3 weeks until progression or maximally 2 years.
Experimental: NSCLC
Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy
 Drug: TATE and pembrolizumab
All liver metastatic lesions will be treated with TATE for maximally debulking. Pembrolizumab IV infusion every 3 weeks until progression or maximally 2 years.


Outcome Measures
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Primary Outcome Measures :
  1. ORR [ Time Frame: 24 months ]
    per RECIST 1.1


Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: 24 months ]
    per RECIST 1.1

  2. Response rate [ Time Frame: 24 months ]
    in TATE treated or TATE-untreated lesions by RECIST and mRECIST

  3. PFS [ Time Frame: 24 months ]
    Progression Free Survival

  4. TTP [ Time Frame: 24 months ]
    Time to Progression

  5. OS [ Time Frame: 36 months ]
    Overall Survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04701476


Contacts
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Contact: Ray Lee, MD. PhD. 8043341076 ray.lee01@teclison.com

Locations
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United States, California
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Cindy Duong       duongca@hs.uci.edu   
Contact: Jasmine Balangue       balanguj@hs.uci.edu   
Taiwan
China Medical University Hsinchu Hospital Recruiting
Hsinchu, Taiwan
Contact: sandy Lai       sandy6618@teclison.com   
Chung Shan Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Sandy Lai       sandy6618@teclison.com   
Sponsors and Collaborators
Teclison Ltd.
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Ray Lee Teclison Limited
More Information
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Responsible Party: Teclison Ltd.
ClinicalTrials.gov Identifier: NCT04701476    
Other Study ID Numbers: LT-007
KEYNOTE-A91 ( Other Identifier: Merck & Co. )
First Posted: January 8, 2021    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: International meeting report or medical Journal publication

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teclison Ltd.:
colorectal cancer
NSCLC
pembrolizumab
tirapazamine
Additional relevant MeSH terms:
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Lung Neoplasms
Colorectal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents