Study of Domvanalimab, Zimberelimab, and Chemotherapy for Patients with Advanced Esophageal or Gastric Cancer

3 1 1 1

What is this study about?

This clinical trial is focused on studying treatments for people with certain types of cancer in the upper part of the digestive system, specifically gastric cancer, gastroesophageal junction cancer, and esophageal cancer. These cancers are either locally advanced, meaning they have grown but not spread to distant parts of the body, or metastatic, meaning they have spread to other areas. The study is testing a new combination of treatments that includes two experimental drugs, domvanalimab and zimberelimab, along with chemotherapy. Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. This new combination will be compared to another treatment that uses the drug nivolumab with chemotherapy.

The purpose of the study is to see if the new combination of domvanalimab and zimberelimab with chemotherapy can help people live longer compared to the treatment with nivolumab and chemotherapy. Participants in the study will be randomly assigned to receive either the new combination treatment or the nivolumab treatment. The study will last for up to 24 months, during which participants will receive their assigned treatment and be monitored regularly by the study team. The study will also look at how the treatments affect the participants’ quality of life and any side effects they may experience.

In addition to the main goal of comparing how long participants live with each treatment, the study will also look at other important factors. These include how long it takes for the cancer to start growing again, how many participants experience a reduction in their cancer size, and how long these reductions last. The study will also monitor any side effects or adverse events that participants may experience during the trial. This information will help researchers understand the safety and effectiveness of the new treatment combination.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis, and performance score.

Informed consent is required, ensuring understanding of the study’s requirements and restrictions.

2 randomization

Participants are randomly assigned to one of two treatment groups: one receiving domvanalimab and zimberelimab with chemotherapy, and the other receiving nivolumab with chemotherapy.

3 treatment administration

The treatment involves a combination of medications administered through different routes.

Capecitabine is taken orally.

Fluorouracil, nivolumab, zimberelimab, domvanalimab, and oxaliplatin are given as infusions.

Calcium folinate is administered as an injection.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment and any side effects.

Assessments include measuring the size of the cancer and checking for any progression or response.

5 end of treatment

The treatment continues until the study’s end date or until the disease progresses or unacceptable side effects occur.

The study aims to compare overall survival and other outcomes between the two treatment groups.

Who Can Join the Study?

  • Must be at least 18 years old at the time of signing the consent form.
  • Must be able to give signed consent, agreeing to the study’s requirements and restrictions.
  • Must have a confirmed diagnosis of advanced or spread (metastatic) stomach, gastroesophageal junction (GEJ), or esophageal cancer. This means the cancer is either too advanced to be removed by surgery or has spread to other parts of the body.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. This score is a way to measure how well a person can perform daily activities. A score of 0 means fully active, and 1 means some symptoms but still able to do light work.
  • Must have at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. This means there should be a tumor that can be measured to see if it changes in size during the study.

Who Cannot Join the Study?

  • Patients with other types of cancer besides esophageal or gastric cancer cannot participate.
  • Patients who have not been diagnosed with metastatic esophageal or gastric cancer are excluded. Metastatic means the cancer has spread to other parts of the body.
  • Patients who do not have high PD-L1 expression are excluded. PD-L1 is a protein that can affect how the immune system fights cancer.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to receive the specific treatments being tested in the study are excluded.
  • Patients who are part of a vulnerable population, which may include those who cannot give informed consent, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Azienda Ospedaliero Universitaria Careggi Florence Italy
Hospital Universitario Hm Sanchinarro Madrid Spain
Medisprof S.R.L. Cluj Napoca Romania
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Oncopole Claudius Regaud Toulouse France
IRCCS Humanitas Research Hospital Rozzano Italy

Other Sites

Site Name City Country Status
Sigmedical Services S.R.L. Suceava Romania
Orszagos Onkologiai Intezet Budapest Hungary
Centrul De Oncologie-Euroclinic S.R.L. Iasi Romania
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Radiotherapy Center Cluj S.R.L. Floresti Romania
Spitalul Judetean De Urgenta Dr. Constantin Opris Baia Mare Baia Mare Romania
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Ospedale San Raffaele S.r.l. Milan Italy
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Champalimaud Clinical Centre Lisbon Portugal
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Budapest Hungary
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
General Oncological Hospital Of Kifissia Agioi Anargyroi Kifissia Greece
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Hopital Prive Des Cotes D’armor Plerin France
University Of Pecs Pecs Hungary
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Hopital Huriez Lille France
Centre Francois Baclesse Caen France
Metropolitan Hospital Athens Greece
Fundeni Clinical Institute Bucharest Romania
Izszlapj Rcovqouh Dk Cnksyq Dz Moozzsgvgwo Montpellier France
Cadrka Llke Bmbbou Lyon France
Hrqfmobt Ubhmtnnhnforv Mmmygdw Dl Vctzdqlgqz Santander Spain
Idnuaddf Cylbmt Dueaktynopkisokvx L'hospitalet De Llobregat Spain
Auucqwlznw Pszazyyj Hhxrgfup Dp Mnhcbylae Marseille France
Buhpzvkldjg Vhvfxjmrf Ojnxptvuioim Kecskemet Hungary
Arzweb Mcabckz Cuaqrm Smhq Thessaloniki Greece
Nbikbeix Iysjxzmz Ozrmhadll Ine Mkstz Szwriuqkmmskodtyndxmyokgemxk Iyucvkch Bfuorcub Cracow Poland
Cawzax Hvlfwwbmqx E Uitqzqdvvdbyx Dy Cffiqrd Ecdjnn Coimbra Portugal
Vvvxsycmz imiwmwrv Vipuvtfs uxkdkibrdohx ltgfwsehn Sspydtro khzpgyw fjtdtrnb Nhbltyqyswcl vhuvk cuvbqmb Vilnius Lithuania
Hinhqfym Vszi dbmhprfi Barcelona Spain

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

Trial status

Country Status Recruitment Start
France France
Not recruiting
28.10.2022
Greece Greece
Not recruiting
28.10.2022
Hungary Hungary
Not recruiting
28.10.2022
Italy Italy
Not recruiting
28.10.2022
Lithuania Lithuania
Not recruiting
28.10.2022
Poland Poland
Not recruiting
28.10.2022
Portugal Portugal
Not recruiting
28.10.2022
Romania Romania
Not recruiting
28.10.2022
Spain Spain
Not recruiting
28.10.2022

Trial locations

Domvanalimab is an investigational medication being studied for its potential to help the immune system fight cancer. It is being tested in combination with other treatments to see if it can improve survival in patients with certain types of advanced stomach and esophageal cancers.

Zimberelimab is another investigational medication that is part of the trial. It is designed to work with the immune system to target and destroy cancer cells. Researchers are studying its effectiveness when used alongside other therapies in treating advanced cancers of the stomach and esophagus.

Nivolumab is a medication that helps the immune system recognize and attack cancer cells. It is already used in the treatment of various cancers and is being tested in this trial to see how well it works in combination with chemotherapy for patients with advanced stomach and esophageal cancers.

Chemotherapy refers to the use of drugs to kill or slow the growth of cancer cells. In this trial, chemotherapy is used in combination with other medications to evaluate its effectiveness in treating advanced cancers of the stomach and esophagus.

Esophageal Cancer – This is a disease where malignant cells form in the tissues of the esophagus, the tube that carries food from the throat to the stomach. It often begins in the cells lining the inside of the esophagus and can grow to invade deeper layers and nearby structures. As it progresses, it may cause difficulty swallowing, weight loss, and chest pain. The cancer can spread to nearby lymph nodes and other parts of the body. Risk factors include smoking, heavy alcohol use, and certain dietary habits.

Gastric Cancer – Also known as stomach cancer, this disease involves the growth of cancerous cells within the lining of the stomach. It typically starts in the mucus-producing cells on the stomach’s inner surface and can develop into a tumor. As it advances, it may lead to symptoms like indigestion, stomach pain, nausea, and loss of appetite. The cancer can spread to nearby organs and lymph nodes. Factors such as infection with Helicobacter pylori, smoking, and certain dietary factors can increase the risk.

Metastatic Esophageal Cancer – This condition occurs when esophageal cancer spreads beyond the esophagus to other parts of the body, such as the liver, lungs, or bones. The spread of cancer cells can lead to additional symptoms depending on the organs affected. It often results in more severe symptoms and complications compared to localized esophageal cancer. The progression involves the cancer cells traveling through the bloodstream or lymphatic system. This stage of cancer is more challenging to manage due to its widespread nature.

Metastatic Gastric Cancer – This form of cancer arises when gastric cancer cells spread from the stomach to other areas of the body, such as the liver, lungs, or peritoneum. The spread can cause new symptoms related to the affected organs, in addition to those caused by the primary tumor. The cancer cells can travel through the blood or lymphatic system to distant sites. This stage indicates a more advanced progression of the disease, often leading to complex clinical scenarios.

Trial ID:
2023-507522-16-00
Protocol code:
STAR-221
NCT ID:
NCT05568095
Trial Phase:
Therapeutic confirmatory (Phase III)

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