Not recruiting

Study of Regorafenib and Avelumab for Adults with Advanced or Metastatic Solid Tumors

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 the effects of two medications, Regorafenib and Avelumab, in treating various types of advanced or metastatic solid tumors. These tumors include several types of cancer such as colorectal cancer, gastric cancer, liver cancer, lung cancer, and others. Regorafenib is a medication taken orally in the form of a film-coated tablet, while Avelumab is administered through an intravenous infusion, which means it is given directly into a vein.

The purpose of this study is to explore the safety and effectiveness of combining these two medications in treating the mentioned cancers. The study is divided into two phases. In the first phase, the focus is on determining the best dose of Regorafenib when used with Avelumab and understanding any side effects. The second phase aims to assess how well this combination works against the tumors. Patients participating in the study will receive the medications and be monitored for their response to the treatment over time.

Throughout the study, participants will undergo regular assessments to track the progress of their disease and any changes in their condition. These assessments may include imaging tests like MRI or CT scans to evaluate the size and spread of the tumors. The study will help gather important information on how these medications can be used together to potentially improve treatment outcomes for patients with these challenging types of 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.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the trial's objectives and procedures. Consent is required before any study-specific procedures begin.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes a review of medical history, current health status, and any previous treatments.
Step 3
Treatment phase I
The patient will receive avelumab through an intravenous infusion and regorafenib in the form of film-coated tablets taken orally.
The primary goal is to determine the recommended dose for phase II, assess safety, and identify any side effects during the first 28 days.
Step 4
Treatment phase II
The focus shifts to evaluating the effectiveness of the treatment in reducing tumor size or slowing disease progression.
The patient will continue receiving the same medications, with regular monitoring to assess response and any side effects.
Step 5
Regular monitoring
Throughout the trial, the patient will undergo regular check-ups, including blood tests and imaging scans, to monitor health and treatment effects.
Step 6
End of treatment
Upon completion of the treatment period, a final assessment will be conducted to evaluate the overall response to the treatment.
Step 7
Follow-up
After the treatment ends, follow-up visits will be scheduled to monitor long-term health and any delayed effects of the treatment.

Who can join the trial?

17 criteria

Must be an adult patient with advanced or metastatic solid tumors.
Must have a confirmed diagnosis of specific types of cancer, such as colorectal cancer, GIST, or others, depending on the study phase.
Must have adequate blood, kidney, liver, and metabolic functions. This includes specific levels for hemoglobin, neutrophils, platelets, and other blood components.
Must not have had another malignant disease diagnosed or treated in the last 3 years, except for certain types of skin or cervical cancers.
Must have had at least four weeks since the last chemotherapy, immunotherapy, or other treatments.
Must have recovered from any side effects of previous treatments to a certain level, except for hair loss and mild nerve damage.
Women who can have children must have a negative pregnancy test before starting the study medication.
Both men and women must agree to use effective birth control during the study and for a period after stopping the treatment.
Must provide written consent to participate in the study.
Must have social security in compliance with French law.
Must show disease progression before entering the study, confirmed by specific imaging tests.
Must have advanced, non-resectable, or metastatic disease.
Must be at least 18 years old.
Must have a performance status of 1 or less, which means being able to carry out light activities.
Must have measurable disease according to specific criteria.
Must have a life expectancy of more than 3 months.
Must have had at least one previous line of systemic therapy, except for certain cancer types.

Who cannot join the trial?

3 criteria

Patients who are not adults.
Patients who do not have advanced or metastatic solid tumors.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Regional Et Universitaire De Brest
Verified
Brest, France
Centre Leon Berard
Verified
Lyon, France
Institut Curie - Site Paris
Verified
Paris, France

Trial locations

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Investigated drugs

Regorafenib
is a medication used in this clinical trial to treat various types of advanced solid tumors. It works by blocking certain proteins that promote cancer cell growth and helps to slow down or stop the spread of cancer cells. In this study, Regorafenib is being tested in combination with another medication to determine the best dose and to evaluate its effectiveness in different types of cancer.
Avelumab
is another medication involved in this trial. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. Avelumab is used in combination with Regorafenib to enhance the body's ability to fight cancer. The study aims to assess the safety and effectiveness of this combination in treating various solid tumors.

What is already known about the treatment

Regorafenib
Regorafenib is administered orally in tablet form and is currently being studied in combination with Avelumab for treating advanced or metastatic solid tumors. It is a multi-kinase inhibitor that works by blocking several enzymes involved in tumor growth and angiogenesis, which is the formation of new blood vessels that supply the tumor. This medication is classified as a targeted cancer therapy and is being evaluated for its effectiveness in various types of cancers, including colorectal cancer, gastric carcinoma, and hepatocellular carcinoma, among others.
Avelumab
Avelumab is administered through intravenous infusion and is being tested in combination with Regorafenib for the treatment of advanced or metastatic solid tumors. It is an immune checkpoint inhibitor that works by blocking the PD-L1 protein, which helps cancer cells evade the immune system. By inhibiting this protein, Avelumab enhances the body's immune response against cancer cells. It is classified as an immunotherapy and is being investigated for its potential to treat a wide range of cancers, including urothelial cancer, non-small cell lung cancer, and triple-negative breast cancer.

Investigated diseases

Colorectal Cancer
Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps that can develop into cancer over time. As the disease progresses, it can invade nearby tissues and spread to other parts of the body. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others become more advanced and metastatic.
Gastrointestinal Stromal Tumor (GIST)
GIST is a rare type of tumor that occurs in the digestive tract, most commonly in the stomach or small intestine. It originates from specialized cells in the gastrointestinal tract wall known as interstitial cells of Cajal. These tumors can vary in size and may be benign or malignant. As they grow, they can cause symptoms such as abdominal pain, bleeding, or obstruction. The progression of GIST can be slow or aggressive, depending on the tumor's characteristics.
Oesophageal or Gastric Carcinoma
This type of cancer affects the esophagus or stomach, often beginning in the cells lining these organs. It can develop due to factors like chronic irritation from acid reflux or infection with Helicobacter pylori. As the cancer progresses, it can invade deeper layers of the esophagus or stomach and spread to nearby lymph nodes and other organs. Symptoms may include difficulty swallowing, weight loss, and stomach pain. The disease can advance to a metastatic stage if not detected early.
Biliary Tract Cancer
Biliary tract cancer, also known as cholangiocarcinoma, occurs in the bile ducts that carry bile from the liver to the small intestine. It can develop in different parts of the bile duct system, including intrahepatic, perihilar, or distal locations. The cancer may cause symptoms like jaundice, itching, and abdominal pain as it progresses. It can spread to nearby tissues and organs, making it challenging to treat if not caught early. The progression can vary based on the tumor's location and size.
Hepatocellular Carcinoma
Hepatocellular carcinoma is the most common type of primary liver cancer, often associated with chronic liver diseases such as hepatitis and cirrhosis. It begins in the main type of liver cell, the hepatocyte, and can grow as a single tumor or multiple small nodules. As the cancer progresses, it can invade blood vessels and spread to other parts of the body. Symptoms may include weight loss, upper abdominal pain, and jaundice. The disease's progression can be rapid, especially in the presence of underlying liver damage.
Soft Tissue Sarcoma
Soft tissue sarcoma is a group of cancers that arise in the connective tissues, including muscles, fat, and blood vessels. These tumors can occur anywhere in the body but are most common in the arms, legs, and trunk. They often grow silently and may not cause symptoms until they are large enough to press on nearby structures. As the sarcoma progresses, it can spread to other parts of the body, particularly the lungs. The progression and behavior of the tumor can vary widely depending on its type and location.