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Study on the Effects of Rilvegostomig and Drug Combination for Patients with Advanced Gastric or Gastroesophageal Junction 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

This clinical trial is focused on studying treatments for a type of cancer called gastric or gastroesophageal junction adenocarcinoma. This cancer affects the stomach and the area where the stomach meets the esophagus. The study will explore the effectiveness and safety of new drug combinations in patients with advanced stages of this cancer, where the disease cannot be surgically removed or has spread to other parts of the body.

The trial will involve several medications, including capecitabine, calcium folinate, fluorouracil, oxaliplatin, and new investigational drugs such as Rilvegostomig (also known as AZD2936), volrustomig (MEDI5752), AZD7789, and AZD0901. These medications will be administered in different combinations to evaluate their impact on the cancer. Some of these drugs are given as tablets, while others are administered through an infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to assess how well these new drug combinations work in treating the cancer and to monitor their safety. Participants will receive treatment over a period of up to 24 months. The study will track how the cancer responds to the treatment and whether the participants remain free from disease progression for at least six months. The trial will also monitor any side effects and how the body processes the drugs. Some participants may receive a placebo as part of the study. The trial aims to provide valuable information that could lead to better treatment options for this type of cancer in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, weight, and medical condition.

    The study focuses on individuals with **locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma**.

  2. Step 2

    Treatment initiation

    Treatment begins with the administration of various medications.

    Medications include **capecitabine** and **fluorouracil**, which are given orally and intravenously, respectively.

    Other medications such as **calcium folinate**, **rilvegostomig**, **oxaliplatin**, **volrustomig**, and **azd0901** are administered intravenously.

  3. Step 3

    Medication schedule

    The dosage and frequency of each medication are determined by the study protocol.

    The duration of administration is specified within the study guidelines.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the **efficacy** and **safety** of the treatment.

    Assessments include physical examinations, laboratory tests, and vital sign checks.

  5. Step 5

    Response evaluation

    The **objective response rate (ORR)** and **progression-free survival at 6 months (PFS6)** are evaluated.

    These evaluations help determine the effectiveness of the treatment.

  6. Step 6

    Study completion

    The study is estimated to conclude by March 31, 2026.

    Final assessments are conducted to gather comprehensive data on the treatment's impact.

Who can join the trial?

7 criteria

  • Must be **18 years or older** at the time of signing the informed consent form.
  • Must have a **body weight** greater than **35 kg** (about 77 pounds).
  • Must not have received any previous treatment for **unresectable** (cannot be removed by surgery) or **metastatic** (cancer that has spread) **gastric or gastroesophageal junction adenocarcinoma** (a type of stomach cancer).
  • Must have a **measurable target disease** as assessed by the study doctor using a standard method called **RECIST 1.1** (a set of rules to measure cancer response to treatment).
  • Must have an **ECOG PS** (Eastern Cooperative Oncology Group Performance Status) of **0 or 1**, which means the patient is fully active or has some symptoms but can carry out light work.
  • Must have a **life expectancy** of at least **12 weeks**.
  • Must have **adequate organ and bone marrow function**, meaning the organs and bone marrow are working well enough to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had previous treatments that might interfere with the study results.
  • Patients with other serious health conditions that could affect their safety during the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures for any reason.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of substance abuse that could interfere with the study.
  • Patients who have an active infection that requires treatment.
  • Patients who have a mental health condition that might affect their ability to participate.
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Investigated drugs

  • Novel Agent

    This is a new medication being tested in the trial. It is combined with standard chemotherapy to see if it can improve the treatment outcomes for patients with advanced gastric or gastroesophageal junction cancer. The goal is to determine if this novel agent can help shrink tumors or stop them from growing.

  • Chemotherapy

    Chemotherapy is a standard treatment for cancer that uses drugs to kill cancer cells or stop them from growing. In this trial, chemotherapy is used in combination with the novel agent to evaluate if the combination is more effective than chemotherapy alone in treating advanced gastric or gastroesophageal junction cancer.

What is already known about the treatment

Novel Agent – This medication is administered in combination with chemotherapy, typically through intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. The main therapeutic indication is to improve the objective response rate and progression-free survival in patients with these conditions. At the molecular level, the novel agent works by targeting specific pathways involved in cancer cell growth and survival, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational cancer therapy.

Investigated diseases

Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma – This is a type of cancer that originates in the glandular cells lining the stomach or the area where the stomach meets the esophagus. It is termed "locally advanced" when the cancer has spread to nearby tissues or lymph nodes but not to distant parts of the body. "Unresectable" indicates that the cancer cannot be removed completely through surgery. When it is "metastatic," the cancer has spread to other parts of the body. The disease often progresses by invading surrounding tissues and can lead to symptoms such as difficulty swallowing, weight loss, and abdominal pain. As the cancer advances, it may affect the function of the stomach and nearby organs.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510977-27-00Protocol codeD7986C00001Estimated enrolment341 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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