MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

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.

Primary Outcome Measures

Objective response rate (ORR) [ Time Frame: 3 months-2 years ]Percentage of subjects with complete or partial response

Secondary Outcome Measures

  1. duration of response (DUR) [ Time Frame: up to 2 years ]measured from first observation of response to disease progression
  2. progression free survival (PFS) [ Time Frame: up to 2 years ]measured from start of study to date of progression or death

Other Outcome Measures

  1. Incidence of adverse events [ Time Frame: up to 2 years ]description of adverse events by frequency, severity and causality
  2. 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

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

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Source: the U.S. National Institutes of Health via ClinicalTrials.gov. Last updated: July 12th, 2019.

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Last update: May 07, 2019. 08:38:48 pm.