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

Withdrawn before enrolling · Phase 1

Conditions studied: Malignant Pleural Mesothelioma (MPM)

In brief

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.

Key facts

Study ID

NCT02661659

Run by

University of Chicago

People needed

0

Starts

2016-06-12

Expected to finish

2017-10-03

Last updated by the study team

2018-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• 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)
• radiotherapy for the target disease
• 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

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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