TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Teclison

Status and phase: Enrolling; Phase 2

Conditions: Colorectal Cancer; Lung Cancer

Treatments: Drug: TAS-102 pill; Drug: TATE and pembrolizumab; Drug: Regorafenib Pill

Study type: Interventional

Funder types: Industry

Identifiers

NCT04701476

LT-007

KEYNOTE-A91 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

colorectal cancer

Experimental group

Description:

metastatic colorectal cancer progressed on at least two lines of chemotherapy

Treatment:

Drug: Regorafenib Pill

Drug: TATE and pembrolizumab

Drug: TAS-102 pill

NSCLC

Experimental group

Description:

Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy

Treatment:

Drug: TATE and pembrolizumab