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UnknownPhase 2NCT04013334
Official study title

MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMTG201 and Nivolumab Injection [Opdivo]

The study team can explain what participation involves.

Who it may be forMesothelioma · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 16, 2022 · Source: ClinicalTrials.gov

Is enrollment open?Unknown

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Momotaro-Gene Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Momotaro-Gene Inc.
Interventions being studied
Drug: MTG201; Drug: Nivolumab Injection [Opdivo]
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Mesothelioma→
Disease setting
Recurrent or relapsed→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Baylor College of MedicineHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 16, 2022. Always confirm current availability with the study team.

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