MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

Part of paid clinical trials in Houston, Texas.

Sponsor
Momotaro-Gene Inc.
Study ID
NCT04013334
Phase
PHASE2
Status
Unknown

Conditions

  • Malignant Pleural Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MTG201 — DRUG
    MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50
  • Nivolumab Injection [Opdivo] — DRUG
    Nivolumab 480 mg by IV infusion every 4 weeks

Study Details

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.

Key Dates

Start date
Aug 15, 2019
Status verified
Jun 2022
Primary completion
Dec 31, 2022
Completion
Jan 1, 2023

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MTG201 plus Nivolumab
    Single arm, open-label, patients receive both MTG201 and nivolumab

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 3 months-2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030-

Find similar trials in Houston, TX

By research site
Baylor College of Medicine· Houston, TX

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