MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

NCT04013334 | Unknown Phase 2 FDA Drug

• 1 other identifier: MTG201-MPM-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Mesothelioma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Percentage of subjects with complete or partial response

  3 months-2 years

Secondary Outcomes (2)

• duration of response (DUR)

  up to 2 years

• progression free survival (PFS)

  up to 2 years

Other Outcomes (2)

• Incidence of adverse events

  up to 2 years

• change from baseline in liver transaminases

  up to 2 years

Study Arms (1)

MTG201 plus Nivolumab

EXPERIMENTAL

Single arm, open-label, patients receive both MTG201 and nivolumab

Drug: MTG201; Drug: Nivolumab Injection [Opdivo]

Interventions

MTG201 DRUG

MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50

Also known as: Ad-SGE-REIC/Dkk-3

MTG201 plus Nivolumab

Nivolumab Injection [Opdivo] DRUG

Nivolumab 480 mg by IV infusion every 4 weeks

Also known as: Opdivo

MTG201 plus Nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Momotaro-Gene Inc.: lead
• Baylor College of Medicine: collaborator
• Synteract, Inc.: collaborator

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bryan Burt, MD

  Baylor College of Medicine Thoracic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, open-label

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: July 9, 2019
• Study Start: August 15, 2019
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2023
• Last Updated: June 16, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)