Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250036
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-12-11
Brief Title:
Peri-operative Zimberelimab Anti-PD-1 vs Zimberelimab in Combination With Domvanalimab Anti-TIGIT in Resectable Mismatch Repair DeficientMicro-satellite Unstable Gastric and Gastro-oesophageal Junctional Adenocarcinoma ZODIAC
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Royal Marsden NHS Foundation Trust
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZODIAC
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 gastricgastro-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 dMMRMSI-H gastricGOJ 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 nonpoor responders
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 nonpoor responders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None