Phase 2 Stomach Cancer Trial, Recruiting NCT06250036 Sponsor: Royal Marsden NHS Foundation Trust Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT06250036
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older
  • People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus, confirmed by a tissue biopsy
  • People whose cancer has a specific genetic feature called MMR deficiency or microsatellite instability-high (MMRd/MSI-H), detected by one of three approved laboratory tests
  • People whose cancer is at stage II to IIIB (the cancer has grown into the stomach wall and may involve nearby lymph nodes, but has not spread to distant parts of the body)
  • People who have had scans (CT and PET) and a keyhole surgical check (staging laparoscopy) showing no spread of cancer to distant organs
  • People whose medical team has determined that surgery is appropriate and that a complete surgical removal of the cancer is likely achievable after initial treatment
  • People who have not previously received any cancer treatment for this stomach or junction cancer
  • People with a general health and activity level rated as ECOG 0–2 (ranging from fully active to capable of limited self-care) (confirm with trial site)
  • People whose blood counts and organ function meet the required laboratory levels, including adequate white blood cells, platelets, haemoglobin, kidney function, liver function, and blood clotting measures
  • People who are willing and able to follow all trial procedures, attend scheduled visits, and complete all required examinations and treatments
  • People who have given written informed consent before joining the trial

Who may not be able to join:

  • People who have had a severe allergic reaction (including anaphylaxis) to monoclonal antibody treatments in the past
  • People who have previously received any cancer immunotherapy, including treatments targeting PD-1, PD-L1, PD-L2, TIGIT, CD137, or CTLA-4 pathways
  • People who have taken immune-suppressing medications (such as high-dose steroids or certain other drugs) within the two weeks before starting the trial, with some exceptions for low-dose or localised steroid use
  • People who have had another active cancer within the past two years, with some exceptions for certain localised or previously treated cancers such as skin cancers, early prostate cancer, or breast cancer being managed with hormone therapy with no known active disease
  • People whose medical team recommends radiotherapy as part of their standard treatment for this cancer
  • People with a specific type of heart rhythm irregularity detected on an ECG (QTc of 480 milliseconds or more)
  • People whose cancer has spread to distant parts of the body, including to the lining of the abdomen (peritoneum), as seen on imaging or during the keyhole surgical check
  • People who have previously had an organ transplant, including a bone marrow or stem cell transplant
  • People with an active autoimmune disease that has needed systemic treatment in the past two years, or that may worsen with immunotherapy — though several specific conditions are considered on a case-by-case basis (confirm with trial site for details)
  • People with a history of inflammatory bowel disease, except those with ulcerative colitis who have had their colon surgically removed
  • People with a history of a lung condition called interstitial lung disease, or scan evidence of lung scarring (pulmonary fibrosis)
  • People who have had a stroke or mini-stroke (TIA) within the six months before starting the trial
  • People with certain serious heart conditions, including a heart attack in the past year, certain uncontrolled heart rhythm problems, unstable chest pain (angina), or significant heart failure
  • People with an active infection requiring treatment, or wounds, ulcers, or bone fractures that have not healed
  • People who have had major surgery or a significant injury within 28 days before joining the trial (not counting the staging laparoscopy)
  • People with other serious or uncontrolled medical conditions — affecting the liver, blood, gut, hormone system, lungs, or heart — that the trial doctors believe could affect safety or participation
  • People with serious psychiatric conditions, including active suicidal thoughts or behaviour in the past year
  • People with active or uncontrolled Hepatitis A, B, or C — though people with past (resolved) Hepatitis B or certain Hepatitis C situations may still be eligible (confirm with trial site)
  • People with uncontrolled HIV infection — though people with well-controlled HIV on stable treatment may be eligible (confirm with trial site)
  • People who have received a live vaccine within 28 days before starting the trial, or who may need one during the trial
  • People who are pregnant or breastfeeding; women and men who could potentially conceive must agree to use highly effective contraception during the trial and for the required period after the last dose of study treatment

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Naureen Starling, The Royal Marsden NHSFT UK

Phone: 02086613279

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Royal Marsden NHS Foundation Trust
Registry
ClinicalTrials.gov
Start date
20 February 2025
Est. completion
20 March 2027

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

Efficacy of zimberelimab +/- domvanalimab in patients with resectable MMRd/MSI-H gastric/GOJ adenocarcinoma who proceed to surgery

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov