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TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

Primary Purpose

Colorectal Cancer; Lung Cancer

Status

Recruiting

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

TATE and pembrolizumab

TAS-102 pill

Regorafenib Pill

About this trial

This is an interventional treatment trial for Colorectal Cancer; Lung Cancer focused on measuring colorectal cancer, NSCLC, pembrolizumab, tirapazamine, Liver metastasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of California, Irvine Medical CenterRecruiting
China Medical University Hsinchu HospitalRecruiting
Chung Shan Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

colorectal cancer

NSCLC

Arm Description

metastatic colorectal cancer progressed on at least two lines of chemotherapy

Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy

Outcomes

Primary Outcome Measures

Overall Survival for the mCRC cohort

From the first day of treatment to death

Overall Response Rate (ORR) for the NSCLC cohort

Per RECIST 1.1 criteria

Secondary Outcome Measures

Duration of Response

per RECIST 1.1

Response rate

in TATE treated or TATE-untreated lesions by RECIST and mRECIST

PFS

Progression Free Survival

TTP

Time to Progression

Full Information

NCT ID

NCT04701476

First Posted

January 6, 2021

Last Updated

September 18, 2023

Sponsor

Teclison Ltd.

Collaborators

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT04701476

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 20, 2021 (Actual)

Primary Completion Date

October 30, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teclison Ltd.

Collaborators

Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer; Lung Cancer

Keywords

colorectal cancer, NSCLC, pembrolizumab, tirapazamine, Liver metastasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

colorectal cancer

Arm Type

Experimental

Arm Description

metastatic colorectal cancer progressed on at least two lines of chemotherapy

Arm Title

NSCLC

Arm Type

Experimental

Arm Description

Liver metastatic NSCLC progressed on immune checkpoint inhibitors and chemotherapy

Intervention Type

Drug

Intervention Name(s)

TATE and pembrolizumab

Other Intervention Name(s)

TATE: Trans-arterial Tirapazamine Embolization;

Intervention Description

All liver metastatic lesions will be treated with TATE for maximally debulking. Pembrolizumab IV infusion per standard schedule every 3 or 6 weeks until progression or maximally 2 years.

Intervention Type

Drug

Intervention Name(s)

TAS-102 pill

Other Intervention Name(s)

LONSURF

Intervention Description

The comparator of the mCRC arm is TAS-102 at 60 mg BID 5 days per week for 2 weeks then 2 weeks off.

Intervention Type

Drug

Intervention Name(s)

Regorafenib Pill

Other Intervention Name(s)

STIVARGA

Intervention Description

As an alternative to TAS-102 per treating physician's discretion. If selected, Regorafenib 160 mg oral daily for 3 weeks on and one week off, every 4 weeks per cycle. Do not take Regoarefnib if taking TAS-102.

Primary Outcome Measure Information:

Title

Overall Survival for the mCRC cohort

Description

From the first day of treatment to death

Time Frame

24 months

Title

Overall Response Rate (ORR) for the NSCLC cohort

Description

Per RECIST 1.1 criteria

Time Frame

within 24 months

Secondary Outcome Measure Information:

Title

Duration of Response

Description

per RECIST 1.1

Time Frame

24 months

Title

Response rate

Description

in TATE treated or TATE-untreated lesions by RECIST and mRECIST

Time Frame

24 months

Title

PFS

Description

Progression Free Survival

Time Frame

24 months

Title

TTP

Description

Time to Progression

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ray Lee, MD. PhD.

Phone

8043341076

ray.lee01@teclison.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chiwei Lu

chiwei.lu4@teclison.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ray Lee

Organizational Affiliation

Teclison Limited

Official's Role

Study Director

Facility Information:

Facility Name

University of California, Irvine Medical Center

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miranda Duron

mnduron@hs.uci.edu

Facility Name

China Medical University Hsinchu Hospital

City

Hsinchu

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

sandy Lai

sandy6618@teclison.com

Facility Name

Chung Shan Medical University Hospital

City

Taichung

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sandy Lai

sandy6618@teclison.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

International meeting report or medical Journal publication

Learn more about this trial

TATE and Pembrolizumab (MK3475) in mCRC and NSCLC

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