Clinical trial NCT04701476: TATE and Pembrolizumab (MK3475) in mCRC and NSCLC
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Colorectal Cancer; Lung Cancer
Keywords: colorectal cancer
NSCLC
pembrolizumab
tirapazamine
Liver metastasis
Lead sponsor: Teclison Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2021-01-08
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Overall Survival for the mCRC cohort
timeFrame: 24 months
measure: Overall Response Rate (ORR) for the NSCLC cohort
timeFrame: within 24 months
Secondary outcomes:
measure: Duration of Response
timeFrame: 24 months
measure: Response rate
timeFrame: 24 months
measure: PFS
timeFrame: 24 months
measure: TTP
timeFrame: 24 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Hsinchu
country: Taiwan
facility: China Medical University Hsinchu Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Teclison Limited
name: Ray Lee
role: STUDY_DIRECTOR
References: