At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Single agent zimberelimab (drug), Combination zimberelimab + domvanalimab (drug)
- How long the study runs
- Study runs about 79 months (dates as stated)
- About the drug or intervention
- Single agent zimberelimab — drug: Single agent zimberelimab (PD-1 inhibitor) Q3W · Combination zimberelimab + domvanalimab — drug: Combination zimberelimab + domvanalimab (TIGIT inhibitor) Q3W
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 50
- Started
- 2025-02-20
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for locally advanced gastric adenocarcinoma
- • Phase2 - 50 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with locally advanced gastric adenocarcinoma
Where?
- • Cambridge - Addenbrooke's Hospital
- • Exeter - Royal Devon University Healthcare Foundation Trust
- • Canterbury - Kent & Canterbury Hospital
- • Leeds - St James's University hospital
- • +6 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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)
More detail
Primary objective The primary objective of the trial is to evaluate the efficacy of zimberelimab +/- domvanalimab as peri-operative treatment in resectable MMRd/MSI-H gastric/GOJ adenoca. A chemotherapy-sparing approach. The primary endpoint is pathological complete response rate at surgery, and to identify which is the most promising experimental arm (zimberelimab alone vs zimberelimab in combination with domvanalimab). 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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
- How fit you need to be: ECOG 0 or better
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ cancer immunotherapy including anti-PD-1
- ✓ systemic treatment in the past 2 years (i
- ✓ a baseline ophthalmologic exam to rule out ocular manifestations
- ✓ during the study
What the study is looking for
- ✓Inclusion criteria
- ✓Age: ≥18 years
- ✓confirmed by a biopsy gastric or gastro-oesophageal junctional (GOJ) adenocarcinoma (inclusive of Siewert-stein...
- ✓MMRd/MSI-H. There are three different methods validated for detection (63) :
- ✓Immunohistochemistry (IHC) staining for expression of MMR proteins (MLH1, MSH2, PMS2 and MSH6), MMRd defined as loss...
See the full criteria
Where Is This Study? (10 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
Royal Devon University Healthcare Foundation Trust
Exeter EX2 5DW, United Kingdom
Kent & Canterbury Hospital
Canterbury CT1 3NG, United Kingdom
St James's University hospital
Leeds LS9 7TF, United Kingdom
Ninewells hospital and Medical School
Dundee DD1 9SY, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
University College London Hospital NHS Foundation Trust
London N15 6UL, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825The Royal Free NHS Foundation Trust
London NW32QG, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
The Royal Marsden NHSFT
London SW3 6JJ, United Kingdom
