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

The research process

The trial runs in 7 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 specific criteria, including age, cancer type, and previous treatments.

    A signed, written informed consent is required before participation.

  2. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

14 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

  • Regorafenib

    This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating refractory, advanced gastro-oesophageal cancer. Regorafenib is primarily used for its anti-cancer properties, particularly in cases where other treatments have failed. It works by inhibiting multiple protein kinases, which play a role in tumor growth and angiogenesis, effectively slowing down or stopping the growth of cancer cells. Regorafenib is classified as a multi-kinase inhibitor.

  • Nivolumab

    This medication is administered intravenously, typically through an infusion. It is being investigated in clinical trials for its potential to improve survival rates in patients with refractory, advanced gastro-oesophageal cancer. Nivolumab is used as an immunotherapy treatment, helping the immune system recognize and attack cancer cells. It functions by blocking the PD-1 protein on immune cells, enhancing the body's immune response against cancer. Nivolumab is classified as a checkpoint inhibitor.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505441-69-00Protocol codeAG0315OG/CTC0140Estimated enrolment460 patientsSponsorInstitut fuer Klinische Krebsforschung IKF GmbH

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