Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Study pausedPhase2

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

Sponsor: Royal Marsden NHS Foundation Trust

NCT ID: NCT06250036

View on ClinicalTrials.gov ↗

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.

Locally Advanced Gastric AdenocarcinomaMSI-H/dMMR Gastric CancerMSI-H/dMMR Gastroesophageal-junction Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

MSIMMRmetPD-L1CD137known positivePatients positivereaction is negative

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
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 Prothrombin Time (APTT) \< 1.5xULN * Before patient registration/randomisation, written informed consent must be given according to ICH/GCP, and national/local regulations * Patient is fit to undergo all protocol investigations and receive all protocol treatment based on the assessment in the surgical / oncology clinic * Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment * Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans Exclusion criteria Patients are not eligible for the trial if any of the exclusion criteria below are met: * Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3CTCAE v5.0, any history of anaphylaxis * Any prior treatment with cancer immunotherapy including anti-PD-1, anti-TIGIT, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways * Treatment with systemic immunosuppressive medications, including but not limited to: corticosteroids (dose of \> 10mg/day prednisone equivalent) cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumour necrosis factor \[TNF\] agents) within 2 weeks prior to Cycle 1 Day 1 * Prior malignancy active within the previous 2 years except for: * locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix * localised prostate cancer * breast cancer diagnosed \>2 years ago, now on adjuvant endocrine therapy (no known active disease) * Patients recommended to have radiotherapy as part of routine management for their gastric/GOJ AC are ineligible QTc ≥480 msec using Fredericia QT correction formula * Metastatic disease on imaging or staging laparoscopy - visualisation of peritoneal disease on staging laparoscopy is an exclusionPrior organ transplantation, including allogeneic stem-cell transplantation * Any active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or is expected to deteriorate when receiving immunotherapy, with the following exceptions: * Patients with autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible * Patients only receiving hormone replacement therapy e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy (doses ≤10mg - or equivalent - of prednisolone per day) for adrenal or pituitary insufficiency) are eligible * Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only not requiring immunosuppressive treatment are eligible, providing they meet the following conditions * Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations * Rash mush cover less than 10% of body surface area * Disease is well controlled at baseline and only requiring low-potency topical steroids * No acute exacerbations of underlying condition within the last 12 months * Patients with controlled type 1 diabetes mellitus on a stable dose of insulin regimen are eligible * Patients requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement * Administration of steroids through a route known to result in minimal systemic exposure (topical, intranasal intra-ocular, or inhalation) are acceptable. Steroids as pre-medication for hypersensitivity reactions e.g., CT contrast are also acceptable * History of inflammatory bowel disease with the following exception: * Patients with a history of ulcerative colitis who have had a colectomy are eligible * Patients with a history of interstitial lung disease or radiological evidence of pulmonary fibrosis * Cerebrovascular disease (including transient ischaemic attacks (TIA) and strokes) within the 6 months prior to Cycle 1 Day 1 * Cardiovascular diseases as follows: * Myocardial infarction within the previous year * Serious cardiac arrhythmia requiring medication (for example, ventricular tachycardia, supraventricular tachycardia or atrial fibrillation with a resting heart rate \> 110bpm) * Unstable angina * Congestive cardiac failure (New York Heart Association Classification Class III or IV), EF \<50% * Active infection requiring systemic therapy, non-healing wound, ulcer or bone fracture requiring therapy * Major surgery, major trauma within 28 days prior to registration (not including staging laparoscopy) * Current signs or symptoms of any other severe progressive or uncontrolled hepatic, haematologic, gastrointestinal, endocrine, respiratory or cardiac disease other than directly related to gastric/GOJ adenocarcinoma, which in the opinion of the investigator, might impair the subject's tolerance of trial treatment or procedures * Other severe acute or chronic medical conditions or psychiatric conditions including recent (within the past year) active suicidal ideation or behaviour * Active/ uncontrolled Hepatitis A, B or C infection, for hepatitis B known positive HBV surface antigen (HBsAg) result, patients with past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are only eligible if polymerase chain reaction is negative for HCV RNA. * Uncontrolled human immunodeficiency virus (HIV) infection * If known HIV diagnosis and well controlled on anti-retrovirals (CD4 count ≥350cells/ul and undetectable viral load) patient is eligible, ensure HIV team involvement for management and monitoring whilst on treatment * Use of live attenuated vaccine within 28 days of initiation of study therapy, or anticipation that a live attenuated vaccine will be required during the study * Pregnancy must be excluded with a negative serum pregnancy test, within 3 days before initiation of therapy, if the risk of conception exists. Sexually active female patients must be surgically sterile or be postmenopausal or must agree to use highly effective contraception. Sexually active male patients must be surgically sterile or must agree to use highly effective contraception, i.e. methods with a failure rate of \<1% per year (see section 5.4 for full definition and examples of highly effective contraception) * Lactation-breast-feeding is contraindicated and must be discontinued for the duration of the study period and for the required duration of the contraception use after the last dose of the study drug. * Any patient specific factors which are likely to interfere with compliance of trial specific procedures or treatment, including any medical or psychiatric conditions that in the investigator's or sponsor's opinion poses an undue risk to the participant's participation in the study or may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Where Is This Study? (10 UK sites)

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

Royal Devon University Healthcare Foundation Trust

Exeter EX2 5DW, United Kingdom

Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Kent & Canterbury Hospital

Canterbury CT1 3NG, United Kingdom

St James's University hospital

Leeds LS9 7TF, United Kingdom

Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

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

Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

The Royal Free NHS Foundation Trust

London NW32QG, United Kingdom

Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Guy's and St Thomas' NHS Foundation Trust

London SE1 9RT, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

The Royal Marsden NHSFT

London SW3 6JJ, United Kingdom

Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416
Data sourced from ClinicalTrials.gov · Last verified: 2026-08