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Study on Regorafenib and Nivolumab for Patients with Advanced Gastro-Oesophageal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as advanced gastro-oesophageal cancer, which affects the stomach and the area where the stomach meets the esophagus. The study is investigating the effects of a combination treatment using two medications: regorafenib and nivolumab. Regorafenib, also known by its code name BAY 734506, is a medication taken orally in the form of a film-coated tablet. It works as a multi-kinase inhibitor, which means it blocks certain proteins that help cancer cells grow. Nivolumab, marketed as Opdivo, is given as an infusion into a vein and is a type of protein that helps the immune system attack cancer cells.

The purpose of this study is to determine how well the combination of regorafenib and nivolumab, referred to as RegoNivo, improves the overall survival of patients compared to standard chemotherapy treatments. Participants in the study will be randomly assigned to receive either the RegoNivo treatment or the standard chemotherapy. The study will last for a period of up to 24 months, during which participants will receive regular treatments and follow-up assessments to monitor their health and the progression of the cancer.

Throughout the study, researchers will collect information on various aspects, such as how long patients live, how the cancer responds to the treatment, and the quality of life of the participants. The study will also look at the safety of the treatment by monitoring any side effects that may occur. This research aims to provide valuable insights into the potential benefits of using RegoNivo for treating advanced gastro-oesophageal cancer.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, cancer type, and previous treatments.

A signed, written informed consent is required before participation.

2 randomization

Participants are randomly assigned to receive either the combination of regorafenib and nivolumab or standard chemotherapy.

This process ensures that each participant has an equal chance of receiving either treatment.

3 treatment initiation

Treatment begins within 7 days after randomization.

For those receiving regorafenib and nivolumab, regorafenib is administered orally as a film-coated tablet, and nivolumab is given intravenously as a solution for infusion.

4 treatment schedule

Regorafenib is taken orally once daily for 21 days, followed by a 7-day break, completing a 28-day cycle.

Nivolumab is administered intravenously every 2 weeks.

5 monitoring and assessments

Regular assessments are conducted to monitor health status, including blood tests and imaging scans.

These assessments help evaluate the effectiveness of the treatment and any side effects.

6 follow-up

Participants continue to be monitored for overall survival and progression-free survival.

Quality of life is assessed through questionnaires completed by participants.

7 end of study

The study is estimated to conclude by May 2026.

Final results will be analyzed to determine the impact of the treatments on survival and other outcomes.

Who Can Join the Study?

  • Must be an adult, 18 years or older, with advanced gastro-oesophageal cancer that has spread or returned.
  • The cancer must have started in the gastro-oesophageal area, like the junction between the esophagus and stomach or the stomach itself.
  • The type of cancer should be adenocarcinoma or undifferentiated carcinoma, which are specific types of cancer cells.
  • The cancer must be measurable using a CT scan, a type of imaging test, done within 21 days before joining the study.
  • Must have tried at least two different anti-cancer treatments before, including one with a platinum agent and one with a fluoropyrimidine analogue.
  • If the cancer is HER2-positive, a specific protein, the patient must have received a treatment called trastuzumab.
  • Must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which means being fully active or having some symptoms but still able to do light work.
  • Must be able to swallow pills.
  • Must have adequate bone marrow function, which means having enough platelets, a type of blood cell, and other blood components.
  • Must have adequate kidney function, which means the kidneys are working well enough to clear creatinine, a waste product, from the blood.
  • Must have adequate liver function, which means the liver is working well enough to process bilirubin and other substances in the blood.
  • Must be willing and able to follow all study requirements, including treatments and check-ups.
  • Must be ready to start the study treatment within 7 days after being chosen for the study.
  • Must sign a written informed consent form, which means agreeing to participate after understanding the study details.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not tried other treatments for their cancer that are usually recommended.
  • Patients who have serious health problems that could make it unsafe to participate in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had an organ transplant.
  • Patients who have an active infection that requires treatment.
  • Patients who have a known allergy to the study drugs.
  • Patients who have a history of certain heart conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Universitario De Navarra Pamplona Spain
Haematologisch Onkologische Praxis Eppendorf Hamburg Germany
Medical University Of Vienna Vienna Austria
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Evangelisches Klinikum Bethel gGmbH Bielefeld Germany
Krankenhaus Nordwest GmbH Frankfurt Germany
Caritas Traegergesellschaft Saarbruecken mbH (CTS) Saarbrücken Germany
Hospital Clinico Universitario De Valencia Valencia Spain
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
HELIOS Klinikum Bad Saarow GmbH Bad Saarow Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Klinikum Magdeburg gGmbH Magdeburg Germany
Deutsches Herzzentrum Berlin Berlin Germany
Studienzentrum Onkologie Ravensburg GmbH Ravensburg Germany
Uxkfngcnomjmmjwygyzve Gqumygc uzn Mnxwbjd Gttg Marburg Germany
Kquogpsj Binddzpj Gxkq Bayreuth Germany
Amusras Ubn Igbpf Df Rvybmz Ehgvdo Reggio Emilia Italy
Khhapffm Ecqxpnbcepdemztpfsusstdx Hoyysqiwgrgxtorpu Essen Germany
Hadedgbj Vgwa dmxomlku Barcelona Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
02.05.2022
Germany Germany
Not recruiting
02.05.2022
Italy Italy
Not recruiting
02.05.2022
Spain Spain
Not recruiting
02.05.2022

Trial locations

Investigated drugs:

Regorafenib is a medication used in this trial to treat advanced gastro-oesophageal cancer. It works by blocking certain proteins that help cancer cells grow and spread. This medication is being tested to see if it can improve survival rates when used in combination with another drug.

Nivolumab is an immunotherapy drug that helps the body’s immune system fight cancer. It works by blocking a protein that prevents the immune system from attacking cancer cells. In this trial, it is used alongside regorafenib to see if the combination can improve outcomes for patients with advanced gastro-oesophageal cancer.

Investigated diseases:

Gastroesophageal Cancer – This is a type of cancer that occurs in the stomach and the esophagus, the tube that connects the throat to the stomach. It often begins in the cells lining the inside of these organs and can spread to other parts of the body. As the disease progresses, it may cause symptoms such as difficulty swallowing, weight loss, and stomach pain. The cancer can grow into deeper layers of the stomach or esophagus and may spread to nearby lymph nodes or other organs. Over time, it can lead to more severe symptoms and complications. The progression of the disease can vary depending on the specific characteristics of the cancer and the individual.

Trial ID:
2023-505441-69-00
Protocol code:
AG0315OG/CTC0140
NCT ID:
NCT04879368
Trial Phase:
Therapeutic confirmatory (Phase III)

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