RecruitingPhase 2NCT06250036

Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer

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


Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

50 participants

Start Date

Feb 20, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding immune checkpoint drugs — zimberelimab (anti-PD1) alone or combined with domvanalimab — before surgery improves outcomes for people with resectable (surgically removable) stomach or gastroesophageal junction cancer that has a specific feature called microsatellite instability-high (MSI-H) or mismatch repair deficiency (MMRd). These cancers tend to respond especially well to immunotherapy. **You may be eligible if...** - You are 18 or older - You have confirmed stomach or gastroesophageal junction adenocarcinoma - Your cancer has been confirmed as MSI-H or MMRd - Your cancer is at a resectable stage (stage II-IIIB) with no distant spread - Your medical team believes surgery to completely remove the cancer is achievable **You may NOT be eligible if...** - Your cancer has spread to distant organs - Your cancer does not have the MSI-H/MMRd feature - You are not a surgical candidate - You have active autoimmune disease or prior immunotherapy treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSingle agent zimberelimab

Single agent zimberelimab (PD-1 inhibitor) Q3W

DRUGCombination zimberelimab + domvanalimab

Combination zimberelimab + domvanalimab (TIGIT inhibitor) Q3W


Locations(9)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Royal Devon University Healthcare Foundation Trust

Exeter, Devon, United Kingdom

Ninewells hospital and Medical School

Dundee, Dundee, United Kingdom

Kent & Canterbury Hospital

Canterbury, Kent, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, London, United Kingdom

The Royal Marsden NHSFT

London, London, United Kingdom

St James's University hospital

Leeds, Yorkshire, United Kingdom

St Bartholomew's Hospital

London, United Kingdom

University College London Hospital NHS Foundation Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06250036


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