A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
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ClinicalTrials.gov Identifier: NCT02661659 |
Recruitment Status :
Withdrawn
(PI stopped study due to inability to accrue.)
First Posted : January 22, 2016
Last Update Posted : May 14, 2018
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Condition or disease | Intervention/treatment | Phase |
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Malignant Pleural Mesothelioma (MPM) | Biological: Multipeptide vaccine S-588210 | Phase 1 |
Primary Objective:
To 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.
Secondary Objectives:
- To evaluate the safety of S-588210 in HLA-A*02:01-positive patients with MPM treated with S-588210
- To determine the disease control rate (DCR) in HLA-A*02:01-positive patients with MPM treated with S-588210
- 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
- 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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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 |
Actual Study Start Date : | June 12, 2016 |
Actual Primary Completion Date : | October 3, 2017 |
Actual Study Completion Date : | October 3, 2017 |

Arm | Intervention/treatment |
---|---|
Weekly Vaccination
Maintenance multipeptide vaccine (S-588210) administered every week
|
Biological: Multipeptide vaccine S-588210 |
Every other Week Vaccination
Maintenance multipeptide vaccine (S-588210) administered every other week
|
Biological: Multipeptide vaccine S-588210 |
- 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 [ Time Frame: Within 8 months from initiation of vaccination ]
- Toxicity per Common Terminology Criteria for Adverse Events (CTCAE) v4.03 [ Time Frame: Up to 4 weeks ]
- 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) [ Time Frame: 6 months ]
- 6-month progression-free survival (PFS) rate [ Time Frame: 6 months ]
- Peptide-specific cytotoxic T lymphocyte response determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay [ Time Frame: At 2, 3, 4, 6 and 8 months of vaccination ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- Age>18
- Able to provide informed consent for the study
- HLA-A*02:01 positive
- ECOG PS=0-1 at enrollment
- Measurable indicator lesion by modified RECIST criteria
- 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)
- Archival tumor tissue available for IHC (1 paraffin-embedded block)
- Epithelioid or biphasic histology
Exclusion Criteria:
- Chemotherapy or investigational antineoplastic drug within 1 month of planned initiation of vaccine therapy
- Patients who received DEPDC1, MPHOSPH1, URLC10, CDCA1, or KOC1 peptide vaccines before
- Active treatment with corticosteroids or other immunosuppressive agents
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Patients who are expected to require any of the following therapies between enrollment and completion or discontinuation of the study treatment:
- 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)
- radiotherapy for the target disease
- surgical therapy for the target disease
- History of bone marrow transplantation
- Active infection
- Human immunodeficiency virus infection
- History of or active systemic autoimmune disorder or immunodeficiency syndromes
- History of severe (CTCAE v.4.03 grade 3 or higher) allergic reaction to a drug, vaccination, or biological preparation.
- Pregnancy
- Patients who cannot or do not intend to practice effective contraception
- Severe illness requiring hospitalization
- Lymphocytes <15% of total WBCs at baseline
- Sarcomatoid histology
- Severe (CTCAE v.4.03 grade 3 or higher) concurrent hepatic impairment, renal impairment, heart disease, hematological disease, respiratory disease, or metabolic disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02661659
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 |
Responsible Party: | University of Chicago |
ClinicalTrials.gov Identifier: | NCT02661659 |
Other Study ID Numbers: |
IRB14-1519 |
First Posted: | January 22, 2016 Key Record Dates |
Last Update Posted: | May 14, 2018 |
Last Verified: | May 2018 |
mesothelioma multipeptide vaccine S-588210 |
Mesothelioma Mesothelioma, Malignant Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Pleural Neoplasms Lung Diseases Respiratory Tract Diseases |