Actively Recruiting
Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer
Led by Royal Marsden NHS Foundation Trust · Updated on 2025-08-21
50
Participants Needed
9
Research Sites
340 weeks
Total Duration
On this page
Sponsors
R
Royal Marsden NHS Foundation Trust
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Zimberelimab Anti-PD1 +/- Domvanalimab in Resectable Mmrd Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed gastric or gastro-oesophageal junction adenocarcinoma
- Tumor classified as mismatch repair deficient (MMRd) or high microsatellite instability (MSI-H) by validated methods
- Stage II to IIIB disease (T2-T4, N0-N3, M0)
- No distant metastatic disease confirmed by CT scan, PET CT, and staging laparoscopy
- Multidisciplinary team (MDT) assessment indicating suitability for surgery with achievable R0 resection
- No prior anti-cancer therapy for gastric or gastro-oesophageal junction adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Adequate blood counts and organ function as defined by specific laboratory criteria
- Written informed consent given prior to registration
- Fit to undergo all study procedures and treatments
- Willing and able to comply with study protocol including visits and treatments
You will not qualify if you...
- Severe hypersensitivity to monoclonal antibodies or history of anaphylaxis
- Previous treatment with cancer immunotherapy targeting PD-1, TIGIT, PD-L1, PD-L2, CD137, CTLA-4, or related pathways
- Use of systemic immunosuppressive medications within 2 weeks before study start
- Prior malignancy active within the past 2 years except certain fully cured or controlled cancers
- Planned radiotherapy for gastric or gastro-oesophageal junction adenocarcinoma
- QTc interval 480 msec or more
- Metastatic disease detected by imaging or laparoscopy
- Prior organ transplantation
- Active autoimmune disease requiring systemic treatment within 2 years, with specific exceptions
- History of interstitial lung disease or pulmonary fibrosis
- Recent cerebrovascular or serious cardiovascular disease
- Active infection requiring systemic therapy or non-healing wounds
- Major surgery or trauma within 28 days before registration
- Severe uncontrolled medical or psychiatric conditions
- Active or uncontrolled hepatitis A, B, or C infection with specific conditions
- Uncontrolled HIV infection
- Use of live attenuated vaccine within 28 days before study therapy
- Pregnancy or breastfeeding and unwillingness to use highly effective contraception
- Any factors likely to prevent compliance or pose undue risk as judged by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 9 locations
1
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Actively Recruiting
2
Royal Devon University Healthcare Foundation Trust
Exeter, Devon, United Kingdom, EX2 5DW
Actively Recruiting
3
Ninewells hospital and Medical School
Dundee, Dundee, United Kingdom, DD1 9SY
Actively Recruiting
4
Kent & Canterbury Hospital
Canterbury, Kent, United Kingdom, CT1 3NG
Actively Recruiting
5
Guy's and St Thomas' NHS Foundation Trust
London, London, United Kingdom, SE1 9RT
Actively Recruiting
6
The Royal Marsden NHSFT
London, London, United Kingdom, SW3 6JJ
Actively Recruiting
7
St James's University hospital
Leeds, Yorkshire, United Kingdom, LS9 7TF
Actively Recruiting
8
St Bartholomew's Hospital
London, United Kingdom, EC1A 7BE
Actively Recruiting
9
University College London Hospital NHS Foundation Trust
London, United Kingdom, N15 6UL
Actively Recruiting
Research Team
P
Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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