TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    60
  • sponsor
    Teclison Ltd.
Updated on 3 September 2021

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.

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.

Details
Condition Colorectal Cancer; Lung Cancer, Colorectal Cancer; Lung Cancer, Colorectal Cancer; Lung Cancer
Treatment TATE and pembrolizumab
Clinical Study IdentifierNCT04701476
SponsorTeclison Ltd.
Last Modified on3 September 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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