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Immune Modulation Study of Rilvegostomig and Pembrolizumab in Patients with Advanced Gastric Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on advanced gastric cancer, a late‑stage stomach tumor that has spread beyond the original site. Participants will receive an intravenous infusion of Rilvegostomig (code name AZD2936) and may also be given pembrolizumab, a drug that blocks the immune‑system protein PD-1. The study also explores blocking another protein called TIGIT to see if the combined effect improves the body’s ability to fight the cancer. The purpose of the study is to understand how these treatments change the immune response both in the tumor and throughout the body.

Patients will have a short “window‑of‑opportunity” period during which a small tissue sample (biopsy) is taken before the first infusion and another after the initial dose to look at immune biomarkers, which are signals that indicate how the immune system is reacting. After this phase, regular infusions continue, and doctors perform routine scans and blood tests to monitor the disease. Outcomes such as how long the cancer stays stable without growing (progression-free survival), how many patients see their tumors shrink (overall response rate), and the presence of tumor DNA fragments in the blood (ctDNA) are recorded. Additional laboratory analyses may examine genetic markers like HLA, immune‑activating proteins such as IFN-γ, the presence of immune cells marked by CD8, and the level of a protein called PD-L1 using a staining technique known as IHC. Safety is also closely watched through regular health checks and reporting of any side effects.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    You attend the study site after being assigned to the trial and sign the informed consent form that explains the purpose, procedures, risks, and benefits of the research.

    The study team records your medical history, current medications, and performs a physical examination, vital‑sign measurement, and basic laboratory tests.

    Baseline imaging studies are performed to document the extent of the advanced gastric cancer.

    A baseline tumor biopsy and a blood sample are collected for later comparison with study‑related samples.

  2. Step 2

    First infusion of <b>rilvegostomig</b>

    On the first treatment day you receive an iv infusion of rilvegostomig at a dose of 750 mg.

    The infusion is administered by a qualified health professional in a controlled clinical setting.

    You are observed for a short period after the infusion for any immediate reactions.

  3. Step 3

    Window‑of‑opportunity monitoring and second biopsy

    Following the initial infusion, you enter a short observation phase called the window‑of‑opportunity phase.

    During this time the study team monitors your vital signs, laboratory results, and any symptoms you may experience.

    After the predefined window‑of‑opportunity period, a second tumor biopsy is performed to assess changes in immune biomarkers caused by the rilvegostomig treatment.

  4. Step 4

    Initiation of combination treatment with <b>pembrolizumab</b>

    Once the post‑window‑of‑opportunity biopsy is completed, you begin the combination treatment phase.

    You receive an iv infusion of pembrolizumab (commercially known as KEYTRUDA) at a dose of 200 mg according to the study schedule.

    The combination phase may also include additional doses of rilvegostomig as defined by the protocol, each given as an iv infusion.

  5. Step 5

    Regular treatment cycles and follow‑up visits

    Treatment cycles are repeated at the intervals specified in the study protocol, with each cycle including the scheduled infusions of rilvegostomig and pembrolizumab.

    Before each infusion you undergo a brief physical examination, vital‑sign check, and laboratory testing to ensure safety.

    The study team records any symptoms, side effects, or changes in your health status.

  6. Step 6

    Imaging assessments for disease status

    Periodically, usually every few months, imaging studies such as computed tomography scans are performed to evaluate tumor size and spread.

    The results are used to determine progression‑free survival, which measures the time from the start of treatment until the cancer shows radiological progression or death.

  7. Step 7

    Continuous safety monitoring

    Throughout the trial you are monitored for adverse events, which are any undesirable medical occurrences, and for serious adverse events that may require medical attention.

    The severity of each event is graded according to standard criteria, and any event that is linked to the study drugs may lead to temporary or permanent discontinuation of the medication.

    Laboratory results, vital signs, and physical findings are reviewed at each visit to detect any clinically important changes.

  8. Step 8

    Final study visit and end of treatment

    At the end of the treatment period, a final visit is scheduled to collect concluding blood and tumor samples.

    A final physical examination, laboratory panel, and imaging study are performed to document the overall outcome of the therapy.

    The study team discusses the overall results with you and outlines any further follow‑up that may be recommended.

Who can join the trial?

22 criteria

  • Must be able to read, understand, and sign the informed consent form and any required legal permissions before any study procedures.
  • Must have at least one tumor spot that can be safely sampled with a biopsy.
  • Must have normal blood and organ function, including:
    • Hemoglobin (the protein that carries oxygen in blood) at least 9.0 g/dL and no red‑blood‑cell transfusion in the past 14 days.
    • Absolute neutrophil count (a type of white blood cell that fights infection) at least 1.5 × 10⁹/L.
    • Platelet count (cells that help blood clot) at least 100 × 10⁹/L and no platelet transfusion in the past 14 days.
    • Serum bilirubin (a substance processed by the liver) no higher than 1.5 times the normal limit (or up to 3 times if you have Gilbert’s syndrome).
    • Liver enzymes AST and ALT (tests that show liver health) no higher than 3 times the normal limit (or up to 5 times if liver metastases are present).
    • Kidney function measured by creatinine clearance of at least 45 mL/min.
    • Must have a heart‑pumping ability (called left‑ventricle ejection fraction) of 50 % or higher, measured by an ultrasound of the heart or a special scan.
    • Must be willing and able to follow the study schedule, including taking the medication, attending visits, and completing required exams.
    • Must agree to use reliable birth‑control methods during the study and for 60 days after the last dose:
      • Women who could become pregnant must have a negative pregnancy test and use a highly effective method (such as hormonal contraception, intrauterine device, or a condom with spermicide).
      • Men who could father a child must use a condom with spermicide (or a condom alone if spermicide is unavailable) and ensure their partner also uses effective contraception.
      • Methods like periodic abstinence, rhythm method, or withdrawal are not acceptable.
      • Must have no medical reason that would prevent use of the standard chemotherapy regimens FOLFOX or CAPOX.
      • Must be older than 18 years at the time of enrollment.
      • Must have an ECOG performance status of 0 or 1, meaning you are fully active (0) or able to carry out most daily activities but cannot do strenuous exercise (1).
      • Must weigh more than 30 kg (about 66 lb).
      • Must have a cancer diagnosis confirmed by tissue examination (histology) as gastric or gastro‑esophageal junction adenocarcinoma.
      • The cancer must be unresectable (cannot be removed by surgery) or metastatic (has spread) and you must not have received any prior systemic therapy for advanced disease.
      • Tumor testing must show PD‑L1 CPS score of 1 or higher and be HER2‑negative (meaning the cancer does not over‑express the HER2 protein).
      • You may have had previous curative‑intent treatment (surgery, and possibly chemotherapy or radiation) as long as you have never received immunotherapy before.
      • You must have at least one tumor lesion that can be measured according to the RECIST 1.1 criteria, or disease that can be evaluated (for example, cancer spread to the lining of the abdomen).

Who cannot join the trial?

20 criteria

  • Cannot be in another clinical trial at the same time, unless it is only an observational (non‑interventional) study or a follow‑up of a previous trial.
  • Must not have had an organ transplant (receiving a new organ) or an allogenic stem cell transplant (receiving stem cells from another person).
  • Must not have an autoimmune or inflammatory disease that requires long‑term strong medicines such as disease‑modifying drugs, steroids, or other immune‑suppressing drugs. (Replacement hormones like insulin or thyroid medication may be allowed at the doctor’s discretion.)
  • Must not have had another primary cancer, unless that cancer was treated with curative intent, has been disease‑free for at least three years, and is a low‑risk type (for example, basal cell skin cancer, squamous cell skin cancer, lentigo maligna, or carcinoma in situ that was cured).
  • Must not have a history of cancer spreading to the lining of the brain or spinal fluid (leptomeningeal carcinomatosis) or to the brain itself (central nervous metastases).
  • Must not have a known primary immunodeficiency (a condition where the immune system is weak from birth or early life).
  • Must not test positive for HIV or have an active tuberculosis infection.
  • Must not have an active hepatitis B or hepatitis C infection that meets the study’s laboratory criteria.
  • Must not have any other active or uncontrolled infection that needs systemic (whole‑body) treatment and has not been cleared.
  • Must not have certain heart problems, including serious irregular heartbeats (ventricular arrhythmia), moderate to severe heart failure (New York Heart Association class ≥ 3), a heart attack or unstable chest pain within the past six months, uncontrolled high blood pressure, an abnormal heart‑rhythm test (QT interval > 470 ms), congenital long QT syndrome, low heart‑pumping ability (ejection fraction < 50 %), or other severe cardiac conditions as judged by the investigator.
  • Must not be allergic or hypersensitive to any of the study drugs or their inactive ingredients.
  • Must not have a stomach cancer type that is not an adenocarcinoma (the usual type of gastric cancer).
  • Must not be pregnant, breastfeeding, or plan to become pregnant during the study.
  • Must not have active lung disease such as interstitial lung disease or pneumonitis, serious chronic gastrointestinal problems causing diarrhea, an active primary immunodeficiency, or active skin disease (rash, hives, dermatitis, ulcer, or psoriasis) that needs systemic treatment.
  • Must not have any severe or uncontrolled overall illness, mental health condition, social situation, or substance‑abuse problem that the doctor believes would make participation unsafe or affect adherence to the study protocol.
  • Must not have unresolved side effects from previous cancer therapy that are grade 2 or higher (except hair loss, vitiligo, or certain lab values). Grade 2 nerve damage (neuropathy) will be reviewed individually.
  • Must not be receiving any chemotherapy, investigational product, biologic, or hormonal therapy for cancer at the same time. Hormone therapy for non‑cancer reasons (e.g., hormone replacement) is allowed.
  • Must not have had palliative radiation therapy to a limited area within three weeks before the first dose of the study drug.
  • Must not have used immune‑suppressing medication within 14 days before the first dose, except low‑dose steroids (≤ 10 mg prednisone per day), inhaled or topical steroids.
  • Must not have had a major surgical procedure within 28 days before the first dose (minor local surgery for symptom relief is acceptable).
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Investigated drugs

  • Rilvegostomig

    is an experimental medicine being tested for advanced gastric cancer. It is given through an IV infusion and works by blocking two proteins, PD‑1 and TIGIT, that normally keep the immune system from attacking cancer cells. By blocking these proteins, the drug aims to boost the body’s own immune response both at the tumor site and throughout the body, helping the immune system recognize and destroy the cancer.

  • KEYTRUDA

    (pembrolizumab) is an approved cancer immunotherapy used as a comparison treatment in the study. It is also given by IV infusion and works by blocking the PD‑1 protein, which allows immune cells to better detect and attack cancer cells. In this trial, it serves as a standard reference to see how the new drug’s effects differ from an existing therapy.

What is already known about the treatment

  • Rilvegostomig

    It is given by IV infusion as a solution for infusion, usually 750 mg per dose. Rilvegostomig is an experimental drug still being studied in clinical trials and is not yet approved for regular medical use. It is being tested for treating advanced gastric cancer by blocking two immune checkpoints called PD‑1 and TIGIT, which helps the immune system recognize and attack cancer cells. The drug belongs to the class of immune‑checkpoint inhibitors.

  • Pembrolizumab

    It is administered by IV infusion as a concentrate for solution, typically 200 mg per dose. Pembrolizumab is an approved medication widely used in cancer therapy and is listed in medical literature as a standard treatment. It is used for advanced gastric cancer and other solid tumors by blocking the PD‑1 protein, allowing immune cells to target cancer. It is classified as a monoclonal antibody immune‑checkpoint inhibitor.

Investigated diseases

Gastric cancer - Gastric cancer is a growth of abnormal cells that begins in the lining of the stomach. It often starts as a small lesion that can slowly enlarge and invade deeper layers of the stomach wall. Over time, the tumor may spread to nearby lymph nodes and organs such as the liver or pancreas. The disease can become more widespread, affecting larger portions of the abdomen. As it progresses, more of the stomach may be involved, leading to larger areas of abnormal tissue.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525620-23-00Protocol codeVHIO26001/ESR2523009Estimated enrolment50 patientsSponsorVall D Hebron Institute Of Oncology

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