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
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.
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Objective response rate (ORR)
Secondary Outcome
duration of response (DUR)
Condition
Malignant Pleural Mesothelioma
Intervention
MTG201
Study Arms / Comparison Groups
MTG201 plus Nivolumab
Description: Single arm, open-label, patients receive both MTG201 and nivolumab
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
August 15, 2019
Completion Date
December 20, 2021
Primary Completion Date
September 20, 2020
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Bryan Burt, MD, 512-502-5353, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04013334
Organization ID
MTG201-MPM-001
Responsible Party
Sponsor
Study Sponsor
Momotaro-Gene Inc.
Collaborators
Baylor College of Medicine
Study Sponsor
Bryan Burt, MD, Principal Investigator, Baylor College of Medicine Thoracic Surgery
Verification Date
July 2019