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RecruitingPhase 2

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a treatment called trans-arterial tirapazamine embolization (TATE) together with pembrolizumab. It is for people with colorectal cancer or non-small cell lung cancer that has spread to the liver and has gotten worse despite treatment.

Patients with refractory metastatic colorectal cancer or non-small cell lung cancer with liver metastasis treated with Trans-arterial Tirapazamine Embolization along with Pembrolizumab.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have colorectal cancer that has spread to the liver and is MSS (a type with stable DNA), or non-small cell lung cancer that has spread to the liver without EGFR or AKT gene changes.
  • For colorectal cancer: cancer got worse after at least two rounds of different standard chemotherapy treatments.
  • For lung cancer: cancer got worse after chemotherapy and an immune checkpoint inhibitor, a drug that helps the immune system fight cancer.
  • Have cancer that can be measured.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Have finished chemotherapy at least 4 weeks ago and have no remaining side effects from it.
  • Have organs that work well enough for the study.

Who can't join

  • Have had an organ transplant.
  • Cancer covers more than half of the liver.
  • Have a blood oxygen level below 92% when breathing without extra oxygen.
  • Have a history of an autoimmune disorder, in which the immune system attacks the body.
  • Have cancer that has spread to the brain or spinal cord.
  • Have had major bleeding in the stomach or intestines in the past 2 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

CA