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MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

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ClinicalTrials.gov Identifier: NCT04013334
Recruitment Status : Recruiting
First Posted : July 9, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborators:
Baylor College of Medicine
Synteract, Inc.
Information provided by (Responsible Party):
Momotaro-Gene Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Malignant Pleural Mesothelioma Drug: MTG201 Drug: Nivolumab Injection [Opdivo] Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : September 20, 2020
Estimated Study Completion Date : December 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: MTG201 plus Nivolumab
Single arm, open-label, patients receive both MTG201 and nivolumab
Drug: MTG201
MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50

Drug: Nivolumab Injection [Opdivo]
Nivolumab 480 mg by IV infusion every 4 weeks




Primary Outcome Measures :
  1. 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 [ 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04013334


Contacts
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Contact: Ann Lowe, MD 512-502-5353 amlowe@earthlink.net
Contact: Lolita Sweidan 847-254-9633 Lolita.Sweidan@yourencore.com

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Bryan M Burt, MD    713-798-6376    Bryan.Burt@bcm.edu   
Contact: Michelle Almarez, BBA    713-798-3680    michelle.almarez@bcm.edu   
Sponsors and Collaborators
Momotaro-Gene Inc.
Baylor College of Medicine
Synteract, Inc.
Investigators
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Principal Investigator: Bryan Burt, MD Baylor College of Medicine Thoracic Surgery

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Responsible Party: Momotaro-Gene Inc.
ClinicalTrials.gov Identifier: NCT04013334     History of Changes
Other Study ID Numbers: MTG201-MPM-001
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents