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MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

NCT04013334 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-06-16

No results posted yet for this study

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

Interventions

DRUG

MTG201

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

DRUG

Nivolumab Injection [Opdivo]

Nivolumab 480 mg by IV infusion every 4 weeks

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • Synteract, Inc.

    collaborator INDUSTRY

  • Momotaro-Gene Inc.

    lead INDUSTRY

Principal Investigators

  • Bryan Burt, MD · Baylor College of Medicine Thoracic Surgery

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2022-12-31
Completion
2023-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04013334 on ClinicalTrials.gov