Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer

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What is this study about?

This clinical trial is focused on studying a type of stomach cancer known as HER2-positive gastric cancer. This cancer can also affect the area where the stomach meets the esophagus, called the gastroesophageal junction. The study aims to compare two different treatment approaches for patients with this type of cancer. One group of patients will receive a combination of medications including rilvegostomig, fluoropyrimidine, and trastuzumab deruxtecan. The other group will receive a standard treatment that includes trastuzumab, chemotherapy, and pembrolizumab.

The purpose of the study is to evaluate how effective the new combination of medications is compared to the standard treatment. The study will involve patients receiving these treatments and being monitored over time to see how their cancer responds. The researchers will look at how long patients live without their cancer getting worse and their overall survival time. The study will also monitor any side effects that patients may experience during the treatment.

Participants in the study will receive their treatments through infusions, which means the medication is given directly into a vein. Some medications, like capecitabine, may be taken orally as a tablet. The study will continue for several years to gather enough information to determine the effectiveness and safety of the treatments. This research is important for finding better ways to treat HER2-positive gastric cancer and improve outcomes for patients with this condition.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two treatment groups. This means you will either receive the new treatment being tested or the standard treatment currently used for your condition.

2 treatment group assignment

If assigned to the new treatment group, you will receive a combination of rilvegostomig, fluoropyrimidine, and trastuzumab deruxtecan. These medications are administered through an intravenous infusion, which means they are given directly into your vein.

If assigned to the standard treatment group, you will receive trastuzumab, chemotherapy, and pembrolizumab. These medications are also administered through an intravenous infusion.

3 medication administration

The medications will be given at specific intervals as determined by the study protocol. The exact dosage and frequency will be explained to you by the study team.

You will continue to receive the assigned treatment for the duration specified in the study, unless there are reasons to stop earlier, such as side effects or disease progression.

4 regular check-ups

Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. This includes physical exams, blood tests, and imaging tests.

These check-ups are important to ensure your safety and to gather data on how well the treatment is working.

5 reporting side effects

You will be asked to report any side effects or changes in your health to the study team. This information helps in understanding the safety of the treatment.

The study team will provide guidance on managing any side effects you may experience.

6 end of treatment

At the end of the treatment period, you will have a final set of assessments to evaluate your response to the treatment.

The study team will discuss the results with you and provide information on any further steps or follow-up care needed.

Who Can Join the Study?

Must have a type of cancer called HER2-positive gastric cancer, which affects the stomach or the area where the stomach meets the esophagus.
Must have a PD-L1 combined positive score (CPS) of 1 or higher. This is a measure used to evaluate certain proteins in cancer cells.
Must provide a sample of tumor tissue from a recent biopsy for testing.
Must have cancer that is unresectable (cannot be removed by surgery) and either locally advanced or has spread to other parts of the body (metastatic).
Must not have received prior treatment for this cancer.
Must have a performance status of 0 or 1 according to the WHO or Eastern Cooperative Oncology Group. This is a scale that measures how well a person can perform ordinary tasks and carry out daily activities.
Must have measurable disease that can be assessed by the study doctor using specific criteria (RECISTv1.1).
Must have adequate organ and bone marrow function as determined by tests within 14 days before starting the study.
Must have a left ventricular ejection fraction (LVEF) of 55% or higher within 28 days before starting the study. This is a measure of how well the heart is pumping blood.
Must have completed any previous treatments with enough time before starting the study.
Open to both male and female participants.
Participants must be within the specified age range for the study.

Who Cannot Join the Study?

Patients with any other type of cancer that is not HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma cannot participate. HER2-positive means that the cancer cells have more of a protein called HER2, which can promote the growth of cancer cells.
Patients who have previously received treatment with the study drugs rilvegostomig, fluoropyrimidine, T-DXd, trastuzumab, chemotherapy, or pembrolizumab are not eligible. These are specific medications used to treat cancer.
Patients with severe or uncontrolled medical conditions that could interfere with the study treatment or the safety of the patient cannot join. This means any serious health issues that are not well-managed.
Patients who are pregnant or breastfeeding are not allowed to participate. This is to ensure the safety of both the mother and the baby.
Patients who are unable to comply with the study procedures or follow-up visits are not eligible. This means if someone cannot attend regular check-ups or follow the study rules, they cannot take part.
Patients with known allergies to any of the study drugs or their components cannot participate. An allergy is when your body reacts negatively to a substance.
Patients who have participated in another clinical trial within a certain time frame before this study starts are not eligible. This is to avoid any interference from other treatments.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Centr Georges Francois Leclerc	Dijon	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
IRCCS Humanitas Research Hospital	Rozzano	Italy
Medical University Of Vienna	Vienna	Austria
Universitaetsmedizin Goettingen	Goettingen	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Universitaet Leipzig	Leipzig	Germany
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Istituto Oncologico Veneto	Padua	Italy
Orszagos Onkologiai Intezet	Budapest	Hungary
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre hospitalier universitaire de Liege	Liege	Belgium
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
HELIOS Klinikum Bad Saarow GmbH	Bad Saarow	Germany
Universitair Ziekenhuis Gent	Gent	Belgium
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
Hospital Universitario 12 De Octubre	Madrid	Spain
Bekes Varmegyei Koezponti Korhaz	Gyula	Hungary
SCRI CCCIT Ges.m.b.H.	Salzburg	Austria
Copernicus Podmiot Leczniczy Sp. z o.o.	Gdansk	Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku	Bialystok	Poland
Pia Fondazione Di Culto E Religione Card G Panico	Tricase	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Semmelweis University	Budapest	Hungary
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Azienda Ospedaliera Universitaria Di Cagliari	Monserrato	Italy
Centre Francois Baclesse	Caen	France
Budapesti Uzsoki Utcai Korhaz	Budapest	Hungary
Centre De Lutte Contre Le Cancer Eugene Marquis	Rennes	France
Onkologische Schwerpunktpraxis Kurfuerstendamm	Berlin	Germany
Nje Lwa Gffnzrwile Tkswptaxfjznq Gcrb	Wiener Neustadt	Austria
Csjkyk Ljck Bmjvmq	Lyon	France
Usqnmeahur Mbhysce Ctztwk Hectvhjavohdegpfr	Hamburg	Germany
Usibtxofcjspoehsqtrwz Edlos Ayc	Essen	Germany
Ownmnistptespx Lxga Gzoz	Linz	Austria
Lixzv Ufoemdntpkkn Mjvmyti Cgwihst (scpim	Leiden	The Netherlands
Rqyyepiro Zbgepjxypf Snqqerfky	Arnhem	The Netherlands
Hstbehvq Uvvdwnpwuypyv Mplknny Dm Vdovbbkzso	Santander	Spain
Ucnjdvzzsbgxxvxztictu Apxfqirm	Augsburg	Germany
Anafiewbl Ujh	Amsterdam	The Netherlands
Uoxdqkhcbxnhqrmboysrb Dyruahdyphh Ayi	Duesseldorf	Germany
Apjrfzv Oxrtntmgjzk Ufcxtffqyhqig Cuqtlpsloagn Dqzfv Sqyqqz E Domkn Skvgedj Dn Twggcv	Turin	Italy
Gnrhmvcteqbzgixcv Vyelkirim Pdfw Aompba Erbjgjqi Ogtoha Kbelni	Gyor	Hungary
Nmbdrhhd Ipfpmwxj Ofxudrefd Ixk Mvtld Smbulfiusqufygkdkxofbmicxdry Iehsnqvh Bylgqwmu	Cracow	Poland
Uiukuiwamg Oi Agofmga	Edegem	Belgium
Hiphfock Uulnokwefmfox Haqofhxh Tbetv y Prdtdk Iodmeuio Cyczhd dctrvukbfysnlcbbj (mtdk	Badalona	Spain
Hcjviuip Vwdk dqlvplpv	Barcelona	Spain
Ijzhuvpu Pcdiyqxrymiwbrf Catdam Cvyctk	Marseille	France
Wekdkxkljb Srmekly Iza Szxsson Pmi W Pskymcxrb	Przemysl	Poland

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	28.03.2025
Belgium	Recruiting	28.03.2025
France	Recruiting	28.03.2025
Germany	Recruiting	28.03.2025
Hungary	Recruiting	28.03.2025
Italy	Recruiting	28.03.2025
Poland	Recruiting	28.03.2025
Spain	Recruiting	28.03.2025
The Netherlands	Recruiting	28.03.2025

Trial locations

Investigated drugs:

Rilvegostomig is a medication being studied for its potential to help treat HER2-positive gastric cancer. It is being tested in combination with other treatments to see if it can improve the time patients live without their cancer getting worse and overall survival.

Fluoropyrimidine is a type of chemotherapy drug that is used to treat various cancers, including gastric cancer. It works by interfering with the cancer cells’ ability to grow and divide, which can help slow down or stop the progression of the disease.

Trastuzumab Deruxtecan, also known as T-DXd, is a targeted therapy used to treat HER2-positive cancers. It combines a drug that targets the HER2 protein on cancer cells with a chemotherapy agent, helping to deliver the treatment directly to the cancer cells and potentially improving its effectiveness.

Trastuzumab is a medication that targets the HER2 protein, which is found in high amounts on some cancer cells. By attaching to these proteins, trastuzumab can help slow or stop the growth of the cancer cells.

Pembrolizumab is an immunotherapy drug that helps the body’s immune system recognize and attack cancer cells. It works by blocking a specific protein that prevents the immune system from attacking the cancer, thereby boosting the body’s natural defenses against the disease.

Investigated diseases:

HER2 positive gastric cancer

HER2-positive locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma – This is a type of cancer that occurs in the stomach or the area where the stomach meets the esophagus, characterized by the overexpression of the HER2 protein. The disease begins in the glandular cells lining the stomach or gastroesophageal junction and can spread to nearby tissues and organs. As it progresses, the cancer may invade deeper layers of the stomach wall and spread to lymph nodes or distant organs. Symptoms can include difficulty swallowing, weight loss, and abdominal pain. The progression of the disease can lead to further complications as it affects more areas of the body. The presence of the HER2 protein can influence the behavior and growth rate of the cancer cells.

Trial ID:

2024-512583-57-00

Protocol code:

D702AC00001

NCT ID:

NCT06764875

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Rilvegostomig with Fluoropyrimidine and Trastuzumab Deruxtecan to Standard Treatment for Patients with HER2-positive Gastric Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?