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

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What is this study about?

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.

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.

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.

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.

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.

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.

6 end of treatment

Upon completion of the treatment period, a final assessment will be conducted to evaluate the overall response to the treatment.

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 Study?

  • 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 Study?

  • 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.

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
Oncopole Claudius Regaud Toulouse France
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Ifejsjkb Ryifhyku Dz Cjukpi Dx Mrtlkiwnnrs Montpellier France
Cwqcnu Lcyy Bsqsph Lyon France
Ivolfavj Crqmn Paris France

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
04.05.2018

Trial locations

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.

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.

Trial ID:
2023-509500-15-00
Protocol code:
IB 2017-01
NCT ID:
NCT03475953
Trial Phase:
Human Pharmacology (Phase I) – Other

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