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

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Trial Identification

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

Official 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.

Study ID: NCT03784040

Conditions

Gastric Cancer

Interventions

OTSGC-A24

Nivolumab

Ipilimumab

Study Description

Brief 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

Detailed Description: Primary Objectives 1. Safety cohorts: To evaluate the safety of OTSGC-A24 and nivolumab (+ ipilimumab) in patients with refractory gastric cancer. 2. Arm A: To determine the objective response rate of OTSGC-A24 and nivolumab in advanced gastric cancer. 3. Arm B: To determine the objective response rate of OTSGC-A24 and nivolumab + ipilimumab in advanced gastric cancer. Secondary Objectives 1. To compare the difference in objective response rates between Arm A and Arm B 2. To compare the tumoral immune contexture and PDL-1 expression before treatment, after OTSGC-A24, and after nivolumab (+ ipilimumab) in combination with OTSGC-A24. 3. To determine the serum cytotoxic T-cell response using enzyme-linked immunospot assay (ELISPOT) in PBMC. 4. To determine the progression-free survival (PFS) and overall survival (OS) of Arm A and Arm B. 5. To evaluate the effect of OTSGC-A24 and nivolumab + ipilimumab on clinical and immune PD markers. 6. Evaluate the effects of treatment on peripheral T-cell phenotypic profiles with epitope-specificities by coupling mass cytometric analyses with highly-multiplexed peptide-MHC tetramer staining technology. 7. Identify potential biomarkers for treatment response and mechanisms of secondary resistance by studying gene expression profiles and phenotypic/functional markers of tumour and infiltrating immune cells. End Points - Efficacy The endpoints for efficacy are: * Induction of specific CTL response after vaccination * Response rate * Progression-free survival * Overall survival End Points - Safety The endpoints for safety are: • overall adverse events observed, treatment-related adverse events, and category (eg percentage of patients with any-grade treatment-related adverse events and grade 3-4 treatment-related adverse events).