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Study on Atezolizumab for Patients with High-Risk Stage II or Stage III Colorectal Cancer Not Eligible for Oxaliplatin Chemotherapy

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What is this study about?

This clinical trial is focused on studying a type of cancer called colorectal cancer, specifically in patients who have a high risk of recurrence or have stage III disease. These patients have tumors that are either MSI-high (microsatellite instability-high) or MMR-deficient (mismatch repair-deficient), which are specific characteristics of the cancer cells. The study is for those who cannot receive or choose not to receive a common chemotherapy treatment known as oxaliplatin. The main goal of the study is to see if a medication called atezolizumab, also known by its code name RO5541267, can help improve the chances of staying cancer-free for three years after treatment.

The treatment being tested is atezolizumab, which is given as an infusion, meaning it is administered directly into the bloodstream through a vein. This study will also include a comparison with a placebo, which is a substance with no active medication, to see how effective atezolizumab is on its own. The study will last for up to 12 months, during which participants will receive the treatment and have regular check-ups to monitor their health and the status of their cancer.

Participants in the study will be closely monitored for any side effects or changes in their condition. The study aims to provide valuable information on whether atezolizumab can be a beneficial treatment option for patients with this specific type of colorectal cancer who are not suitable for standard chemotherapy. The results could potentially lead to new treatment options for these patients in the future.

1 joining the study

Upon joining the study, the patient will provide written informed consent, agreeing to participate in the research and any required local authorizations.

The patient must meet specific health criteria, including adequate blood count, liver enzymes, and renal function, and must be willing to comply with the study protocol.

2 treatment initiation

The patient will begin treatment with atezolizumab, a medication administered intravenously.

The specific dosage and frequency of administration will be determined by the study protocol, focusing on improving disease-free survival rates.

3 treatment duration

The treatment with atezolizumab will continue for a period specified by the study, aiming to achieve a disease-free survival rate at 3 years.

Regular monitoring and assessments will be conducted to evaluate the patient’s response to the treatment.

4 follow-up assessments

Throughout the study, the patient will undergo scheduled visits and examinations to monitor health status and treatment effects.

These assessments will include evaluations of disease-free survival, overall survival, and quality of life.

5 completion of study

The study is expected to conclude by February 2025, with final assessments conducted to determine the primary and secondary endpoints.

The primary endpoint focuses on the disease-free survival rate at 3 years, while secondary endpoints include overall survival rates and quality of life measures.

Who Can Join the Study?

  • Provide written informed consent, which means agreeing to participate in the study and any related research.
  • Have specific blood test results: INR and PTT should be less than 1.5 times the normal limit within 7 days before joining the study.
  • Be willing and able to follow the study plan, including attending treatment sessions, visits, and exams.
  • If you are a woman who can have children or a man with a partner who can have children, agree to use very effective birth control methods.
  • Be 18 years of age or older.
  • Have a confirmed diagnosis of a type of cancer called adenocarcinoma in the colon or rectum.
  • Have cancer that is at a specific stage: either high-risk stage II or stage III.
  • Have had a tumor removed with a surgery that was successful (R0) or mostly successful (R1). For a specific part of the study, the tumor should be removable, and a successful surgery is expected.
  • The tumor must be MSI-high (MSI-H) or MMR-deficient (dMMR), which are specific characteristics of the cancer.
  • Have an ECOG status of 0 to 2, which is a measure of your ability to perform daily activities.
  • Be unable to receive a type of chemotherapy called oxaliplatin-based treatment, or choose not to receive it.
  • Have adequate blood counts, liver enzymes, and kidney function. If initial test results are close to the required levels, you may be retested once.

Who Cannot Join the Study?

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have already received oxaliplatin-based chemotherapy.
  • Patients who have not had their tumor completely removed or do not plan to have it removed.
  • Patients who are not willing to follow the study procedures.
  • 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.
  • Patients who have a known allergy to the study medication.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of certain heart conditions.
  • Patients who have a history of certain lung conditions.
  • Patients who have a history of certain liver conditions.
  • Patients who have a history of certain kidney conditions.
  • Patients who have a history of certain immune system conditions.
  • Patients who have a history of certain neurological conditions.
  • Patients who have a history of certain psychiatric conditions.
  • Patients who have a history of substance abuse.
  • Patients who have received a live vaccine within a certain time frame before the study.
  • Patients who have had major surgery within a certain time frame before the study.
  • Patients who have received certain medications within a certain time frame before the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaet Leipzig Leipzig Germany

Other Sites

Site Name City Country Status
Krankenhaus Nordwest GmbH Frankfurt Germany
Asklepios Kliniken Hamburg GmbH Hamburg Germany
HELIOS Klinikum Bad Saarow GmbH Bad Saarow Germany
St. Josef-Hospital Bochum Germany
Petrus-Krankenhaus Wuppertal Germany
Caritas Traegergesellschaft Saarbruecken mbH (CTS) Saarbrücken Germany
Maerkische Kliniken GmbH Luedenscheid Germany
MVM Medizinische Verwaltungs und Managementgesellschaft mbH Leer (ostfriesland) Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Uuvusmphptiirtooeludy Egmim Avn Essen Germany
Kdwrmmyf dnw Uwzwjgaivkjn Mfhvktik Alf Munich Germany
Uofhwxioubgjzlxcvzweu Wovouqmwm Ajl Wuerzburg Germany
Kzpxv Szj Pvcwqv Gnkj Dortmund Germany
Ufgmaoekmzihpllolqudk Dbtswxzpomi Atg Duesseldorf Germany
Mfsopio Kgudkf Ntilphfbji Munich Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.07.2024

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this clinical trial to help improve the disease-free survival rate in patients with certain types of colorectal cancer. It is being tested as an adjuvant treatment, which means it is given after the primary treatment to help prevent the cancer from coming back. This trial focuses on patients with MSI-high or MMR-deficient stage II high risk or stage III colorectal cancer who cannot use oxaliplatin-based chemotherapy. Atezolizumab works by helping the immune system recognize and attack cancer cells.

Investigated diseases:

Colorectal Cancer – Colorectal cancer is a type of cancer that starts in the colon or rectum, parts of the large intestine. It often begins as small, noncancerous clumps of cells called polyps that form on the inside of the colon. Over time, some of these polyps can become cancerous. The disease can progress slowly and may not show symptoms in the early stages. As it advances, 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 may spread to other parts of the body.

Trial ID:
2024-515224-37-00
Protocol code:
AIO-KRK-0220
NCT ID:
NCT05118724
Trial Phase:
Therapeutic exploratory (Phase II)

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