Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-02-24 @ 5:04 AM
Study NCT ID:
NCT02661659
Status:
WITHDRAWN
Last Update Posted:
2018-05-14
First Post:
2016-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}, {'id': 'D008654', 'term': 'Mesothelioma'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI stopped study due to inability to accrue.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-07', 'studyFirstSubmitDate': '2016-01-20', 'studyFirstSubmitQcDate': '2016-01-20', 'lastUpdatePostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who show in vitro cytotoxic T lymphocyte induction to at least 2 of the 5 antigens determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay', 'timeFrame': 'Within 8 months from initiation of vaccination'}], 'secondaryOutcomes': [{'measure': 'Toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v4.03', 'timeFrame': 'Up to 4 weeks'}, {'measure': 'Disease control rate defined as the proportion of patients who are assessed as having complete response (CR), partial response (PR), or stable disease (SD) (>3 months)', 'timeFrame': '6 months'}, {'measure': '6-month progression-free survival (PFS) rate', 'timeFrame': '6 months'}, {'measure': 'Peptide-specific cytotoxic T lymphocyte response determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay', 'timeFrame': 'At 2, 3, 4, 6 and 8 months of vaccination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mesothelioma', 'multipeptide vaccine', 'S-588210'], 'conditions': ['Malignant Pleural Mesothelioma (MPM)']}, 'descriptionModule': {'briefSummary': 'A phase Ib study investigating the safety, the immunogenicity and the optimal administration frequency of the S-588210 5-peptide vaccine in MPM patients without progression after pemetrexed-based chemotherapy will be conducted. Additionally, to identify more accurate predictive biomarkers of response to S-588210, T-cell-receptor-sequencing (TCR) pre- and post-vaccination will be performed in blood samples of patients treated with the vaccine. Immunohistochemical analysis of the vaccine oncoantigens will also be correlated with induction of antigen-specific T-cell responses. Finally, to explore the infiltration of tumors with T-cells and the potential presence of an immunosuppressive tumor microenvironment, immunohistochemistry for immune checkpoints (including PDL1/PD1, CTLA4) and immune suppressive cell subsets (T-regs, macrophages) will be performed.', 'detailedDescription': 'Primary Objective:\n\nTo evaluate the rate of peptide-specific CTL induction to S-588210 within the first 8 months in HLA-A\\*02:01-positive patients with MPM who have not progressed on first-line pemetrexed-based chemotherapy treated on a weekly or every other week vaccination schedule.\n\nSecondary Objectives:\n\n1. To evaluate the safety of S-588210 in HLA-A\\*02:01-positive patients with MPM treated with S-588210\n2. To determine the disease control rate (DCR) in HLA-A\\*02:01-positive patients with MPM treated with S-588210\n3. To determine the progression-free-survival (PFS) in HLA-A\\*02:01-positive patients with MPM who have not progressed on first-line pemetrexed-based chemotherapy and who are treated with S-588210\n4. To evaluate the peptide-specific CTL response to S-588210 over time up to 8 months in HLA-A\\*02:01-positive patients with MPM who have not progressed on first-line pemetrexed-based chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with unresectable MPM that have completed 4-6 cycles of standard first-line pemetrexed-based chemotherapy for at least 1 month and have not progressed\n* Age\\>18\n* Able to provide informed consent for the study\n* HLA-A\\*02:01 positive\n* ECOG PS=0-1 at enrollment\n* Measurable indicator lesion by modified RECIST criteria\n* Adequate bone marrow (ANC \\> 1000cells/ml, PLT \\> 50,000/ml, Hg \\> 8gr/dL), renal (Cr \\> 2.5xUNL) and liver function (AST, ALT\\< 3x UNL, total bilirubin \\< 2x UNL, ALP \\< 3x UNL)\n* Archival tumor tissue available for IHC (1 paraffin-embedded block)\n* Epithelioid or biphasic histology\n\nExclusion Criteria:\n\n* Chemotherapy or investigational antineoplastic drug within 1 month of planned initiation of vaccine therapy\n* Patients who received DEPDC1, MPHOSPH1, URLC10, CDCA1, or KOC1 peptide vaccines before\n* Active treatment with corticosteroids or other immunosuppressive agents\n* Patients who are expected to require any of the following therapies between enrollment and completion or discontinuation of the study treatment:\n\n 1. immunosuppressive drugs, including corticosteroids, methotrexate, mercaptopurine, azathioprine, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, ATG (anti-thymoglobulin), IL2-receptor antibodies (basiliximab, daclizumab), TNF-a antibodies (infliximab, etanercept, adalimumab)\n 2. radiotherapy for the target disease\n 3. surgical therapy for the target disease\n* History of bone marrow transplantation\n* Active infection\n* Human immunodeficiency virus infection\n* History of or active systemic autoimmune disorder or immunodeficiency syndromes\n* History of severe (CTCAE v.4.03 grade 3 or higher) allergic reaction to a drug, vaccination, or biological preparation.\n* Pregnancy\n* Patients who cannot or do not intend to practice effective contraception\n* Severe illness requiring hospitalization\n* Lymphocytes \\<15% of total WBCs at baseline\n* Sarcomatoid histology\n* Severe (CTCAE v.4.03 grade 3 or higher) concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease'}, 'identificationModule': {'nctId': 'NCT02661659', 'briefTitle': 'A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy', 'orgStudyIdInfo': {'id': 'IRB14-1519'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Weekly Vaccination', 'description': 'Maintenance multipeptide vaccine (S-588210) administered every week', 'interventionNames': ['Biological: Multipeptide vaccine S-588210']}, {'type': 'OTHER', 'label': 'Every other Week Vaccination', 'description': 'Maintenance multipeptide vaccine (S-588210) administered every other week', 'interventionNames': ['Biological: Multipeptide vaccine S-588210']}], 'interventions': [{'name': 'Multipeptide vaccine S-588210', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Every other Week Vaccination', 'Weekly Vaccination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}