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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) — ZODIAC  

Metastatic Gastric Cancer Clinical Trial

Official title:
A Randomised Phase II Study of Zimberelimab Anti-PD1 immunOtherapy +/- Domvanalimab Anti-TIGIT Immunotherapy in Resectable Mismatch Repair Deficient Gastric and Gastro-oesophageal Junctional AdenoCarcinoma

Clinical Trial 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)

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06250036
Study type Interventional
Source Royal Marsden NHS Foundation Trust
Contact Project Manager
Phone 02086613279
Email ZODIAC@rmh.nhs.uk
Status Not yet recruiting
Phase Phase 2
Start date April 1, 2024
Completion date September 1, 2031
View Details
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