Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT04013334
Status:
UNKNOWN
Last Update Posted:
2022-06-16
First Post:
2019-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm, open-label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-13', 'studyFirstSubmitDate': '2019-05-24', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'up to 2 years', 'description': 'description of adverse events by frequency, severity and causality'}, {'measure': 'change from baseline in liver transaminases', 'timeFrame': 'up to 2 years', 'description': 'changes in liver transaminases from prior to first study drug treatment to various timepoints throughout the treatment and follow-up period'}], 'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': '3 months-2 years', 'description': 'Percentage of subjects with complete or partial response'}], 'secondaryOutcomes': [{'measure': 'duration of response (DUR)', 'timeFrame': 'up to 2 years', 'description': 'measured from first observation of response to disease progression'}, {'measure': 'progression free survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'measured from start of study to date of progression or death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Pleural Mesothelioma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 IV infusions of nivolumab every 4 weeks. MTG201 is a replication incompetent adenovirus into which the gene for REIC/Dkk-3 has been inserted. The insertion of this gene has been shown to endow the adenovirus with anti-tumor activity and to result in enhanced anti-tumor immunity.\n\nMTG201, 3 x 10E12 vp, will be given by intratumoral injection on days 1, 8, 22 and 50. Nivolumab, 480 mg, will be given by IV infusion every 4 weeks until progression. Efficacy will be assessed by CT scans at 4 and 12 weeks, then every 3 months. Safety will be assessed by reported adverse events, periodic laboratory assessments, physical exams, vital signs. The pharmacokinetics and pharmacodynamics of MTG201 will be assessed periodically. Tumor biopsy will be obtained on Days 1, 8 and 50 prior to MTG201 administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed locally advanced or metastatic pleural mesothelioma\n* Failed one prior treatment regimen including cisplatin-based chemotherapy\n* Eastern cooperative oncology group (ECOG) performance status; 0,1\n* Adequate organ function\n* Measurable disease per RECIST\n\nExclusion Criteria:\n\n* Candidate for surgical resection\n* has active autoimmune disease, primary or acquired immunodeficiency\n* significant cardiovascular disease\n* has active interstitial lung disease\n* has active infection or HIV, hepatitis B or C\n* previous anti-PD-1, PD-L1 or CTLA-4 inhibitor immunotherapy\n* other clinical significant disorder that could affect conduct of study'}, 'identificationModule': {'nctId': 'NCT04013334', 'briefTitle': 'MTG201 Plus Nivolumab in Patients With Relapsed Pleural Mesothelioma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Momotaro-Gene Inc.'}, 'officialTitle': 'A Phase 2, Open-Label, Single-Center Study of MTG201 in Combination With Nivolumab in Patients With Relapsed Malignant Pleural Mesothelioma', 'orgStudyIdInfo': {'id': 'MTG201-MPM-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MTG201 plus Nivolumab', 'description': 'Single arm, open-label, patients receive both MTG201 and nivolumab', 'interventionNames': ['Drug: MTG201', 'Drug: Nivolumab Injection [Opdivo]']}], 'interventions': [{'name': 'MTG201', 'type': 'DRUG', 'otherNames': ['Ad-SGE-REIC/Dkk-3'], 'description': 'MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50', 'armGroupLabels': ['MTG201 plus Nivolumab']}, {'name': 'Nivolumab Injection [Opdivo]', 'type': 'DRUG', 'otherNames': ['Opdivo'], 'description': 'Nivolumab 480 mg by IV infusion every 4 weeks', 'armGroupLabels': ['MTG201 plus Nivolumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Bryan Burt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine Thoracic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Momotaro-Gene Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'Synteract, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}