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.
Checked against the public recordLast updated May 14, 2018 · Source: ClinicalTrials.gov
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
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 * 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.