MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

Malignant Pleural Mesothelioma Clinical Trial

Official title:

A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04013334
• Other study ID #: MTG201-MPM-001
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 15, 2019
• Est. completion date: January 1, 2023

Study information

• Verified date: June 2022
• Source: Momotaro-Gene Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: January 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Mesothelioma
• Mesothelioma
• Mesothelioma, Malignant

Intervention

Drug:
• MTG201
MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50
• Nivolumab Injection [Opdivo]
Nivolumab 480 mg by IV infusion every 4 weeks

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Momotaro-Gene Inc.	Baylor College of Medicine, Synteract, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of adverse events	description of adverse events by frequency, severity and causality	up to 2 years
Other	change from baseline in liver transaminases	changes in liver transaminases from prior to first study drug treatment to various timepoints throughout the treatment and follow-up period	up to 2 years
Primary	Objective response rate (ORR)	Percentage of subjects with complete or partial response	3 months-2 years
Secondary	duration of response (DUR)	measured from first observation of response to disease progression	up to 2 years
Secondary	progression free survival (PFS)	measured from start of study to date of progression or death	up to 2 years