advanced-stage melanoma, advanced-stage renal cell carcinoma Neoantigen peptide vaccine, Immunotherapy, Metastatic cancer
Conditions
Interventions
Personalized neoantigen peptide vaccine consists of 15-30 long peptides combined into four distinct immunizing peptide pools with 0.3 mg of each peptide admixed with 0.5 mg poly-ICLC per pool in a vol
Experimental Biological/Vaccine
Sponsors
Chulalongkorn University
King Chulalongkorn Memorial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age > 18 years - Metastatic or unresectable melanoma or renal cell carcinoma who had progressed on prior therapy or lacked access to further reimbursed standard systemic treatments - Written consent on an IRB/IEC-approved Informed Consent Form (ICF) prior to any study-specific evaluation - The life expectancy of at least 3 months - Eastern Cooperative Oncology (ECOG) performance status of 0 to 1 - Provide either a newly obtained or archival tissue sample sufficient for neoantigen peptide vaccine development. Newly obtained tissue is preferred. - Adequate organ function
Exclusion criteria
Exclusion criteria: - History of severe hypersensitivity reaction to any peptide vaccines. - Any active or suspected autoimmune diseases or a documented history of autoimmune disease, or history of a syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate at week 9, 18 on treatment period and every 12 weeks until disease progression or up to 12 months modified RECIST 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival at 6 month and 12 month modified RECIST 1.1,The incidence of grade 3 or 4 or greater toxicity During treatment and follow-up period NCI CTCAE v4.0,Overall survival at 6 month and 12 month medical record | — |
Countries
Thailand
Contacts
Public ContactVirote Sriuranpong
King Chulalongkorn Memorial Hospital
Outcome results
None listed