Spots Global Cancer Trial Database for Peri-operative Zimberelimab (Anti-PD-1) vs Zimberelimab in Combination With Domvanalimab (Anti-TIGIT) in Resectable Mismatch Repair Deficient/Micro-satellite Unstable Gastric and Gastro-oesophageal Junctional Adenocarcinoma (ZODIAC)

Study Description

Brief Summary: A phase II study of peri-operative anti-PD1 (Zimberelimab) +/- anti-TIGIT (Domvanalimab) in resectable mismatch repair deficient (MMRd)/ high micro-satellite instability (MSI-H) gastric/gastro-oesophageal junctional (GOJ) adenocarcinoma (AC)

Detailed Description: Primary objective The primary objective of the trial is to evaluate the efficacy of zimberelimab +/- domvanalimab as preoperative treatment in improving the pathological complete response (pCR) rate as compared to standard FLOT chemotherapy in resectable dMMR/MSI-H gastric/GOJ AC and to identify the most promising experimental arm. Secondary objectives * To assess the safety and tolerability of zimberelimab+/- domvanalimab in this disease setting * To further assess the efficacy of zimberelimab+/- domvanalimab in terms of radiological response rate, R0 resection rate, progression free survival (PFS) and overall survival (OS) * To evaluate surgical outcomes following treatment with zimberelimab +/- domvanalimab Translational analyses on tissue and blood biomarkers aimed at identifying those who derive the most benefit from this immunotherapy combination, and those who are non/poor responders.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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