Gastric Cancer Clinical Trial
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.
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
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:
ā€¢ 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).
;
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