MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

• Status: Recruiting
• Trial end date: 2021-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Momotaro-Gene Inc.
• Collaborators: Baylor College of Medicine; Synteract, Inc.
• Treatments: Nivolumab

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