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.
- Added: July 12th, 2019.
- Last updated: July 12th, 2019.
Primary Outcome Measures
Objective response rate (ORR) [ Time Frame: 3 months-2 years ]Percentage of subjects with complete or partial response
Secondary Outcome Measures
- duration of response (DUR) [ Time Frame: up to 2 years ]measured from first observation of response to disease progression
- progression free survival (PFS) [ Time Frame: up to 2 years ]measured from start of study to date of progression or death
Other Outcome Measures
- Incidence of adverse events [ Time Frame: up to 2 years ]description of adverse events by frequency, severity and causality
- change from baseline in liver transaminases, ALT and AST [ Time Frame: up to 2 years ]changes in liver transaminases from prior to first study drug treatment to various timepoints throughout the treatment and follow-up period
- 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
- 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
Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: July 12th, 2019.
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