Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-24 @ 2:53 PM
NCT ID:
NCT02661659
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02661659
Study Brief:
Protocol Section:
NCT02661659