TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Sponsor: Teclison Ltd.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04701476

Patient View

This open-label study evaluates TATE and pembrolizumab in patients with liver metastatic MSS-mCRC or NSCLC. mCRC patients are randomized to TATE+pembrolizumab or standard care, assessing OS. NSCLC patients receive TATE+pembrolizumab, focusing on ORR. Eligibility includes prior treatment progression, measurable disease, and adequate organ function. Exclusions include prior transplants and significant liver metastasis.

Patient Parameters

Program Overview

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 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.

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

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