/NCT03784040

Nivolumab, Ipilimumab and OTSGC-A24 Therapeutic Peptide Vaccine in Gastric Cancer - a Combination Immunotherapy Phase Ib Study.

Trial number:: NCT03784040

Trial phase:: 1

Study type:: Immunotherapy

Overall status:: Recruiting

Study start date

February, 2019

Scientific title

da VINci Study (OTSGC-A24 Therapeutic Peptide Vaccine + Ipilimumab + Nivolumab) Nivolumab, Ipilimumab and OTSGC-A24 Therapeutic Peptide Vaccine in Gastric Cancer - a Combination Immunotherapy Phase Ib Study.

Summary

The primary hypothesis is that cancer vaccine can convert non-immunogenic gastric cancer into immunogenic phenotype susceptible to PD1 inhibition. This would lead to an improved radiological response rate and favorable immune contexture for immune checkpoint blockade

1. Histologically or cytologically confirmed inoperable or metastatic gastric cancer that has failed or demonstrated intolerance to standard therapy - which includes platinum or fluoropyrimidine or taxane based chemotherapy.2. Patients must have measurable disease. 3. Age ≥ 21 years 4. ECOG performance status (PS) of 0 to 1 5. Life expectancy at least 3 months 6. Patients must have normal organ and marrow function as defined below:

* Absolute neutrophil count (ANC) ≥ 1,500/mcL * Platelets ≥ 100,000/mcL * Total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) ≤ 2.5 X institutional upper limit of normal * Creatinine \<1.5x normal institutional limits 7. Patients must be HLA-A\*24:02 8. Patients must have recovered (\< grade 1) from all reversible treatment toxicity from prior chemotherapy, radiotherapy or surgery. 9. Ability to understand and the willingness to sign a written informed consent document.

Study design

Primary purpose: TREATMENT, Allocation: NON_RANDOMIZED, Intervention model: PARALLEL, Masking: NONE,

Conditions

Gastric Cancer

Other study ID numbers

2018/00422; GA01/03/18

Choose trial site (1)

National University Hospital 119074

5 Lower Kent Ridge Rd, Singapore 119074