Status:
UNKNOWN
MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
Lead Sponsor:
Momotaro-Gene Inc.
Collaborating Sponsors:
Baylor College of Medicine
Synteract, Inc.
Conditions:
Malignant Pleural Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 expr...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04013334
Start Date
August 15 2019
End Date
January 1 2023
Last Update
June 16 2022
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030