Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-25 @ 1:19 PM
Study NCT ID:
NCT02661659
Status:
WITHDRAWN
Last Update Posted:
2018-05-14
First Post:
2016-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
University of Chicago
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI stopped study due to inability to accrue.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: