Study of Durvalumab and Regorafenib for Patients with Stage IV Colorectal Cancer with No Evidence of Disease

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What is this study about?

This clinical trial is focused on studying treatments for patients with stage IV colorectal cancer who currently show no evidence of the disease. The study will explore the effects of two medications: durvalumab, also known by its code name MEDI4736, and regorafenib, which is referred to as BAY 734506. Durvalumab is given as a solution for infusion, meaning it is administered directly into the bloodstream through a vein, while regorafenib is taken orally as a film-coated tablet.

The purpose of this study is to evaluate how well these treatments work in preventing the return of cancer in patients who have already undergone treatment and currently have no detectable disease. Participants will be randomly assigned to receive either the combination of durvalumab and regorafenib or no additional treatment. The study will last for up to 12 months, during which time the health of the participants will be closely monitored.

The main goal is to determine if the combination of these medications can help patients remain free of cancer for a longer period. The study will also look at the overall survival of participants, any side effects they may experience, and how well they adhere to the treatment plan. This research aims to provide valuable insights into improving outcomes for patients with advanced colorectal cancer.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants must be at least 18 years old and have a confirmed diagnosis of colorectal adenocarcinoma. It is essential to be in a state of no evidence of disease (NED) after completing treatments for stage IV colorectal cancer.

The NED state is verified through imaging tests such as a CT scan, PET scan, or MRI scan. Randomization into the study must occur within 10 weeks of achieving the NED state.

2 randomization

Participants are randomly assigned to one of two groups: one receiving the experimental treatment and the other serving as an untreated control group.

Those who have received additional therapy after local treatment or achieved a complete response with systemic therapies must be randomized within 4 weeks of their last chemotherapy cycle.

3 treatment phase

Participants in the treatment group receive two medications: regorafenib and durvalumab.

Regorafenib is administered orally in the form of a film-coated tablet. The dosage and frequency are determined by the study protocol.

Durvalumab is given as an intravenous infusion, which means it is delivered directly into a vein. The concentration is 50 mg/mL, and the specific dosage and schedule are outlined in the study protocol.

4 monitoring and follow-up

Participants are regularly monitored to assess disease-free survival (DFS), which is the main goal of the study. This involves periodic health assessments and imaging tests.

Secondary outcomes include 18-month DFS, overall survival, and monitoring for any adverse events or side effects from the treatment.

5 completion of the study

The study is expected to conclude by December 31, 2029. Participants will be informed of the study’s findings and any implications for their health.

Throughout the study, compliance with the treatment protocol is evaluated to ensure the accuracy and reliability of the results.

Who Can Join the Study?

Must be 18 years or older.
Must have a confirmed diagnosis of colorectal adenocarcinoma, which is a type of cancer that starts in the colon or rectum.
Must have no evidence of disease (NED) after completing treatments for stage IV colorectal cancer. This means there are no signs of cancer after treatments like surgery, radiofrequency ablation (RFA), radiation therapy (RT), or chemotherapy.
The NED state must be confirmed by a CT scan, PET scan, or MRI scan. These are imaging tests that help doctors see inside the body.
Must be able to start the study within 10 weeks after reaching the NED state. If you had additional therapy after local treatments or achieved a complete response with systemic therapies, you must start the study within 4 weeks after the last chemotherapy cycle.

Who Cannot Join the Study?

Patients who do not have Stage IV colorectal cancer with no evidence of disease (NED) cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Azienda Sanitaria Locale Napoli 1 Centro	Naples	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Cliniche Gavazzeni S.p.A.	Bergamo	Italy
Aectmcn Ovuzrbuxkxc Rnizqbkfn Sop Cppfl	Potenza	Italy
Akcrzro Uhufr Lltwog Ssnlh Sqindusau Ny 1 Dtvwvmdj	Belluno	Italy
Aqxevxw Udyq 9 Slmrljkgn	Legnago	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	04.03.2022

Trial locations

Investigated drugs:

Durvalumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, durvalumab is used to try to prevent the return of colorectal cancer after it has been treated and there is no evidence of disease.

Regorafenib is a medication that targets specific proteins in cancer cells, which can help stop the cancer from growing and spreading. It is used in this trial to see if it can help keep colorectal cancer from coming back after treatment.

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, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. As the disease progresses, it can invade and damage nearby tissues and organs. In advanced stages, cancer cells may spread to other parts of the body through the blood and lymph systems. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.

Trial ID:

2024-518217-26-00

Protocol code:

VIVA

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Durvalumab and Regorafenib for Patients with Stage IV Colorectal Cancer with No Evidence of Disease

What is this study about?

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