Study Comparing XL092 and Atezolizumab with Regorafenib for Patients with Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying treatments for metastatic colorectal cancer, which is a type of cancer that starts in the colon or rectum and spreads to other parts of the body. The study will compare the effectiveness of a new treatment combination of XL092 and atezolizumab against an existing medication called regorafenib. XL092 is a chemical compound that works by inhibiting certain proteins involved in cancer cell growth, while atezolizumab is a type of immunotherapy that helps the immune system recognize and attack cancer cells. Regorafenib is a medication already used to treat this type of cancer.

The purpose of the study is to evaluate the overall survival of patients receiving the combination of XL092 and atezolizumab compared to those receiving regorafenib. Participants in the study will be randomly assigned to receive either the new combination treatment or the existing medication. The study will be conducted over a period of approximately 73 weeks, during which participants will receive their assigned treatment and be monitored for their response to the therapy. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments being studied.

Throughout the study, participants will undergo regular check-ups and tests to monitor their health and the progression of their cancer. The study aims to provide valuable information on the effectiveness and safety of the new treatment combination, potentially offering new hope for patients with metastatic colorectal cancer. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of metastatic colorectal cancer and ensuring previous treatments have been completed or are no longer effective.

A review of medical history and current health status is performed. This includes checking organ and marrow function and ensuring recovery from any previous treatment side effects.

2 randomization

Participants are randomly assigned to one of two treatment groups. One group receives a combination of XL092 and atezolizumab, while the other group receives regorafenib.

3 treatment administration

For those receiving XL092 and atezolizumab:

– XL092 is administered orally in tablet form. The specific dosage and frequency are determined by the study protocol.

– Atezolizumab is given as an intravenous infusion. The dosage is 1,200 mg, and the frequency is determined by the study protocol.

For those receiving regorafenib:

– Regorafenib is administered orally in the form of film-coated tablets. The dosage is 40 mg, and the frequency is determined by the study protocol.

4 monitoring and follow-up

Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects. This includes physical examinations, blood tests, and imaging studies.

Participants are required to report any side effects or changes in health status to the study team.

5 end of treatment

The treatment continues until the study’s end date or until it is determined that the treatment is no longer beneficial.

A final assessment is conducted to evaluate the overall health status and any long-term effects of the treatment.

Who Can Join the Study?

Patients must have a confirmed diagnosis of adenocarcinoma, which is a type of cancer, in the colon or rectum.
If patients or their partners can have children, they must agree to use very effective birth control methods during the study and for a certain time after the last treatment.
Women who can have children must not be pregnant when the study starts. They are considered able to have children unless they have had permanent procedures like removal of the uterus or ovaries, or if they are confirmed to be in menopause, which is when they haven’t had a period for 12 months and are over 45 years old.
Patients must have received certain standard cancer treatments for metastatic colorectal cancer and have shown that these treatments no longer work for them or they cannot tolerate them. Previous experimental treatments are allowed.
Patients must have a measurable disease according to specific criteria used by doctors to assess tumors.
Patients must provide a sample of their tumor tissue. If old samples are not available, they must provide a new sample before starting the study.
Patients must have recovered from any side effects of previous treatments to a certain level, unless these side effects are not significant or are stable with treatment.
Patients must be 18 years or older.
Patients must have a performance status of 0-1, which means they are fully active or have some symptoms but can still do light work.
Patients must have adequate organ and bone marrow function, which will be checked with lab tests before starting the study.
Patients must be able to understand and follow the study requirements and must have signed a consent form agreeing to participate.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not progressed during, after, or are intolerant to standard treatments.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or attend the required visits.
Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have had a recent major surgery or are planning to have surgery during the study.
Patients who have a history of allergic reactions to the study medications.
Patients who have certain infections that could affect the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centr Georges Francois Leclerc	Dijon	France
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Haematologisch Onkologische Praxis Eppendorf	Hamburg	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
Krankenhaus Nordwest GmbH	Frankfurt	Germany
Asklepios Kliniken Hamburg GmbH	Hamburg	Germany
Orszagos Onkologiai Intezet	Budapest	Hungary
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy	Bydgoszcz	Poland
Hospital Foch	Suresnes	France
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital De Santa Maria E.P.E.	Lisbon	Portugal
AZ Turnhout	Turnhout	Belgium
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur	Namur	Belgium
Opolskie Centrum Onkologii Im. Prof. Tadeusza Koszarowskiego W Opolu Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Opole	Poland
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.	Siedlce	Poland
Unidade Local De Saude Do Alto Ave E.P.E.	Guimaraes	Portugal
Hospital Quironsalud Barcelona	Barcelona	Spain
Hopital Prive Jean Mermoz	Lyon	France
Specjalistyczny Szpital Onkologiczny Nu-Med Sp. z o.o.	Tomaszow Mazowiecki	Poland
Hospital Da Luz S.A.	Lisbon	Portugal
Champalimaud Clinical Centre	Lisbon	Portugal
Hospital General Universitario De Valencia	Valencia	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Cveyfasjo Upthqloxxjarsw Saobmhore	Woluwe-Saint-Lambert	Belgium
Ihgnqwyz Rdmdakie Dj Cdmjkg Di Mpdyfyjzoem	Montpellier	France
Iktoffbv Cawalu Dgdvrdihdqpryzsoq	L'hospitalet De Llobregat	Spain
Aifcpxkrey Pmllnrfs Hafxyehg Dg Mbdqlslnj	Marseille	France
Blcvfxml Ubajhgeafv Hyymxcdt Cdarco	Besançon	France
Prbdvkabn Ikylhcgk Mjmjzjdj Mhvcxyilxvea Siaeg Wrguastjxhtj I Atnlmjzzdzsgj	Warsaw	Poland
Hazgxrvg Dh Ln Suozn Coym I Swru Pbf	Barcelona	Spain
Hsaukjiu Vuve ddjxsbud	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	24.01.2023
France	Not recruiting	24.01.2023
Germany	Not recruiting	24.01.2023
Hungary	Not recruiting	24.01.2023
Poland	Not recruiting	24.01.2023
Portugal	Not recruiting	24.01.2023
Spain	Not recruiting	24.01.2023

Trial locations

Investigated drugs:

XL092 is an investigational medication being studied for its potential to treat metastatic colorectal cancer. It is being tested in combination with another medication to see if it can help improve survival rates in patients who have not responded well to standard treatments.

Atezolizumab is a type of immunotherapy known as a checkpoint inhibitor. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, it is used in combination with XL092 to see if the two together can provide better outcomes for patients with metastatic colorectal cancer.

Regorafenib is a medication that is already approved for use in certain types of cancer, including metastatic colorectal cancer. It works by blocking proteins that promote cancer cell growth and survival. In this study, it is being used as a comparison to evaluate the effectiveness of the combination of XL092 and atezolizumab.

Metastatic Colorectal Cancer – This is a type of cancer that begins in the colon or rectum and has spread to other parts of the body. It often progresses through stages, starting in the lining of the colon or rectum and potentially moving to nearby lymph nodes and distant organs, such as the liver or lungs. The disease may cause symptoms like changes in bowel habits, abdominal pain, and weight loss. As it advances, it can lead to more severe symptoms depending on the organs affected. The spread of cancer cells occurs through the bloodstream or lymphatic system. The progression can vary greatly among individuals, influenced by factors like the cancer’s genetic makeup and the patient’s overall health.

Trial ID:

2024-512915-33-00

Protocol code:

XL092-303

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing XL092 and Atezolizumab with Regorafenib for Patients with Metastatic Colorectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?