Malignant Pleural Mesothelioma (MPM) Clinical Trial
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
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.
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:
1. To evaluate the safety of S-588210 in HLA-A*02:01-positive patients with MPM treated
with S-588210
2. To determine the disease control rate (DCR) in HLA-A*02:01-positive patients with MPM
treated with S-588210
3. 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
4. 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
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