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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 : April 21, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
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 Drug: TAS-102 pill Drug: Regorafenib Pill Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open-label study in two indications. The mCRC cohort will be a randomized trial for TATE+Pembrolizumab versus standard 3rd line therapy for mCRC. The NSCLC cohort will be single-arm study.
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 : October 30, 2024
Estimated Study Completion Date : December 31, 2024

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 per standard schedule every 3 or 6 weeks until progression or maximally 2 years.
Other Name: TATE: Trans-arterial Tirapazamine Embolization;

Drug: 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.
Other Name: LONSURF

Drug: 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 Name: STIVARGA
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 per standard schedule every 3 or 6 weeks until progression or maximally 2 years.
Other Name: TATE: Trans-arterial Tirapazamine Embolization;


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival for the mCRC cohort [ Time Frame: 24 months ]
    From the first day of treatment to death

  2. Overall Response Rate (ORR) for the NSCLC cohort [ Time Frame: within 24 months ]
    Per RECIST 1.1 criteria


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


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
  • 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
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 LLC
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: April 21, 2022
Last Verified: April 2022
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
Liver metastasis
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
Tirapazamine
Antineoplastic Agents, Immunological
Antineoplastic Agents