MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
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.
Checked against the public recordLast updated Jun 16, 2022 · Source: ClinicalTrials.gov
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]
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
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.