Clinical Trials /

MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

NCT04013334

Description:

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.

Related Conditions:
  • Pleural Mesothelioma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
  • Official Title: A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma

Clinical Trial IDs

  • ORG STUDY ID: MTG201-MPM-001
  • NCT ID: NCT04013334

Conditions

  • Malignant Pleural Mesothelioma

Interventions

DrugSynonymsArms
MTG201MTG201 plus Nivolumab
Nivolumab Injection [Opdivo]MTG201 plus Nivolumab

Purpose

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.

Detailed Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
MTG201 plus NivolumabExperimentalSingle arm, open-label, patients receive both MTG201 and nivolumab
  • MTG201
  • Nivolumab Injection [Opdivo]

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:3 months-2 years
Safety Issue:
Description:Percentage of subjects with complete or partial response

Secondary Outcome Measures

Measure:duration of response (DUR)
Time Frame:up to 2 years
Safety Issue:
Description:measured from first observation of response to disease progression
Measure:progression free survival (PFS)
Time Frame:up to 2 years
Safety Issue:
Description:measured from start of study to date of progression or death

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Momotaro-Gene Inc.

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