A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
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.
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 14, 2018 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- University of Chicago
- Interventions being studied
- Biological: Multipeptide vaccine S-588210
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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
- Patients who are expected to require any of the following therapies between enrollment and completion or discontinuation of the study treatment: 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) 2. radiotherapy for the target disease 3. 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
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of ChicagoChicago, Illinois
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 14, 2018. Always confirm current availability with the study team.