Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer (NCT06250036) | Clinical Trial Compass
RecruitingPhase 2
Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer
United Kingdom50 participantsStarted 2025-02-20
Plain-language 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)
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* Age: ≥18 years
* Histologically confirmed gastric or gastro-oesophageal junctional (GOJ) adenocarcinoma (inclusive of Siewert-stein classification type I-III (62))
* 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 of function or one or more of these proteins.
* Polymerase chain reaction (PCR) amplification of microsatellite sequences
* Next-generation sequencing (NGS) for detection of MSI
* Stage II-IIIB: TNM T2-T4, N0-N3, M0
* Absence of distant metastatic disease on CT scan + PET CT + staging laparoscopy prior to study entry.
* MDT determined suitable for surgery and MDT believes an R0 resection is achievable after neo-adjuvant therapy (resectable disease)
* No prior anti-cancer therapy for gastric / GOJ adenocarcinoma
* ECOG performance status 0-2
Laboratory parameters
• Adequate haematologic and end-organ function defined by the following laboratory test results: Haematology: Absolute neutrophil count \> 1.5 x 109/L Platelets \> 100 x 109/L Haemoglobin \> 90 x 109/L (can be post-transfusion) Biochemistry: Serum Creatinine Clearance \>50ml/min (calculated using Cockcroft-Gault formula Appendix X)
Liver function: Bilirubin within normal limits ALT/AST ≤2.5x ULN
Coagulation profile (for patients not receiving therapeutic anticoagulation):
International Normalised Ratio (INR) \< 1.5 Activated Pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of zimberelimab +/- domvanalimab in patients with resectable MMRd/MSI-H gastric/GOJ adenocarcinoma who proceed to surgery