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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain
Hfakjxen Ubchzspswqfad Mcoeojk Dd Vgcofknwod Santander Spain
Iborkoxo Ccoxmp Dmzvazznyrynnoesw L'hospitalet De Llobregat Spain
Hynedtki Vczt dnbmlkpi Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
25.03.2024

Trial locations

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.

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 ID:
2024-510977-27-00
Protocol code:
D7986C00001
NCT ID:
NCT05702229
Trial Phase:
Therapeutic exploratory (Phase II)

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