Clinical trial · Interventional
A Phase Ib Trial of a Maintenance Multipeptide Vaccine (S-588210) in Patients With Unresectable Malignant Pleural Mesothelioma Without Progression After First-Line Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI stopped study due to inability to accrue.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Pleural Mesothelioma (MPM) | Pleural Malignant Mesothelioma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multipeptide vaccine S-588210 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Weekly Vaccination
- description
- Maintenance multipeptide vaccine (S-588210) administered every week
- interventionNames
- Biological: Multipeptide vaccine S-588210
- type
- OTHER
- label
- Every other Week Vaccination
- description
- Maintenance multipeptide vaccine (S-588210) administered every other week
- interventionNames
- Biological: Multipeptide vaccine S-588210
Primary outcomes (1)
- measure
- Proportion of patients who show in vitro cytotoxic T lymphocyte induction to at least 2 of the 5 antigens determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available