Clinical trial · Interventional
MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MTG201 | Drug | — | UNRESOLVED |
| Nivolumab Injection [Opdivo] | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MTG201 plus Nivolumab
- description
- Single arm, open-label, patients receive both MTG201 and nivolumab
- interventionNames
- Drug: MTG201
- Drug: Nivolumab Injection [Opdivo]
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 3 months-2 years
- description
- Percentage of subjects with complete or partial response
Secondary outcomes (2)
- measure
- duration of response (DUR)
- timeFrame
- up to 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available