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.
Additional locations may be listed on ClinicalTrials.gov for NCT04013334.
See trial information on ClinicalTrials.gov for a list of participating sites.
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.
Lead OrganizationMomotaro-Gene Inc.
