NCT02661659

A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Malignant Pleural Mesothelioma (MPM)

Interventions

Type	Name	Description
BIOLOGICAL	Multipeptide vaccine S-588210

Timeline

• Start date: 2016-06-12
• Primary completion: 2017-10-03
• Completion: 2017-10-03
• First posted: 2016-01-22
• Last updated: 2018-05-14

Locations

1 site across 1 country: United States