MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
Primary Purpose
Malignant Pleural Mesothelioma
Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MTG201
Nivolumab Injection [Opdivo]
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Pleural Mesothelioma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed locally advanced or metastatic pleural mesothelioma
- Failed one prior treatment regimen including cisplatin-based chemotherapy
- Eastern cooperative oncology group (ECOG) performance status; 0,1
- Adequate organ function
- Measurable disease per RECIST
Exclusion Criteria:
- Candidate for surgical resection
- has active autoimmune disease, primary or acquired immunodeficiency
- significant cardiovascular disease
- has active interstitial lung disease
- has active infection or HIV, hepatitis B or C
- previous anti-PD-1, PD-L1 or CTLA-4 inhibitor immunotherapy
- other clinical significant disorder that could affect conduct of study
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MTG201 plus Nivolumab
Arm Description
Single arm, open-label, patients receive both MTG201 and nivolumab
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
Percentage of subjects with complete or partial response
Secondary Outcome Measures
duration of response (DUR)
measured from first observation of response to disease progression
progression free survival (PFS)
measured from start of study to date of progression or death
Full Information
NCT ID
NCT04013334
First Posted
May 24, 2019
Last Updated
June 13, 2022
Sponsor
Momotaro-Gene Inc.
Collaborators
Baylor College of Medicine, Synteract, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04013334
Brief Title
MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
Official Title
A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Momotaro-Gene Inc.
Collaborators
Baylor College of Medicine, Synteract, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Twelve patients with relapsed malignant pleural mesothelioma will be treated with intratumoral injections of MTG201, a replication incompetent adenovirus, modified by the insertion of the reduced expression in immortalized cells (REIC)/Dikkopf (Dkk)-3 gene, on Days 1, 8, 22, and 50. Patients will also receive every 4 weekly intravenous infusions of nivolumab, 480 mg, starting on Day 2. Safety and anti-tumor activity will be monitored at regular intervals throughout the study.
Detailed Description
This is a study of the efficacy and safety of MTG201 given by intratumoral injection to patients with malignant pleural mesothelioma who have failed front line chemotherapy. Patients will also receive IV infusions of nivolumab every 4 weeks. MTG201 is a replication incompetent adenovirus into which the gene for REIC/Dkk-3 has been inserted. The insertion of this gene has been shown to endow the adenovirus with anti-tumor activity and to result in enhanced anti-tumor immunity.
MTG201, 3 x 10E12 vp, will be given by intratumoral injection on days 1, 8, 22 and 50. Nivolumab, 480 mg, will be given by IV infusion every 4 weeks until progression. Efficacy will be assessed by CT scans at 4 and 12 weeks, then every 3 months. Safety will be assessed by reported adverse events, periodic laboratory assessments, physical exams, vital signs. The pharmacokinetics and pharmacodynamics of MTG201 will be assessed periodically. Tumor biopsy will be obtained on Days 1, 8 and 50 prior to MTG201 administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Mesothelioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single arm, open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MTG201 plus Nivolumab
Arm Type
Experimental
Arm Description
Single arm, open-label, patients receive both MTG201 and nivolumab
Intervention Type
Drug
Intervention Name(s)
MTG201
Other Intervention Name(s)
Ad-SGE-REIC/Dkk-3
Intervention Description
MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50
Intervention Type
Drug
Intervention Name(s)
Nivolumab Injection [Opdivo]
Other Intervention Name(s)
Opdivo
Intervention Description
Nivolumab 480 mg by IV infusion every 4 weeks
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Percentage of subjects with complete or partial response
Time Frame
3 months-2 years
Secondary Outcome Measure Information:
Title
duration of response (DUR)
Description
measured from first observation of response to disease progression
Time Frame
up to 2 years
Title
progression free survival (PFS)
Description
measured from start of study to date of progression or death
Time Frame
up to 2 years
Other Pre-specified Outcome Measures:
Title
Incidence of adverse events
Description
description of adverse events by frequency, severity and causality
Time Frame
up to 2 years
Title
change from baseline in liver transaminases
Description
changes in liver transaminases from prior to first study drug treatment to various timepoints throughout the treatment and follow-up period
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed locally advanced or metastatic pleural mesothelioma
Failed one prior treatment regimen including cisplatin-based chemotherapy
Eastern cooperative oncology group (ECOG) performance status; 0,1
Adequate organ function
Measurable disease per RECIST
Exclusion Criteria:
Candidate for surgical resection
has active autoimmune disease, primary or acquired immunodeficiency
significant cardiovascular disease
has active interstitial lung disease
has active infection or HIV, hepatitis B or C
previous anti-PD-1, PD-L1 or CTLA-4 inhibitor immunotherapy
other clinical significant disorder that could affect conduct of study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Burt, MD
Organizational Affiliation
Baylor College of Medicine Thoracic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
We'll reach out to this number within 24 hrs