Long-Term Study for Cancer Patients Using Atezolizumab Therapy

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What is this study about?

This clinical trial is focused on studying the effects of a medication called atezolizumab, which is marketed under the name Tecentriq. The study is designed for patients who have been previously involved in a study sponsored by Genentech or F. Hoffmann-La Roche Ltd. The main goal is to provide continued access to atezolizumab-based therapy for patients who were receiving it in a previous study and do not have access to it locally. The study primarily involves patients with cancer, although future studies may include other types of cancer.

Participants in this study will continue to receive atezolizumab or a comparator agent, which is another treatment used for comparison, if they were benefiting from it in the previous study. The treatment is administered as a solution for infusion, meaning it is given directly into the bloodstream through a vein. The study will observe patients over a long period to monitor their health and any side effects they may experience. This includes tracking any serious adverse events, which are unexpected medical problems that occur during treatment, and their severity.

The study will also look at the time from when patients start the treatment to when they may pass away from any cause, specifically for those who were part of a previous study called IMpower133. This trial aims to ensure that patients who were benefiting from atezolizumab can continue their treatment safely and effectively, while also gathering important information about the long-term effects of the medication.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria. This includes the ability to continue or switch to atezolizumab-based therapy or a comparator agent, as determined by the previous study.

A negative pregnancy test is required for women of childbearing potential within 7 days before starting the study treatment.

2 treatment initiation

The first dose of the study treatment is administered within 7 days of the treatment interruption window allowed by the previous study.

The treatment involves atezolizumab, administered as an intravenous infusion. The specific dosage is 1,200 mg of Tecentriq, which is a concentrate for solution for infusion.

3 treatment continuation

Continued access to atezolizumab-based therapy or a comparator agent is provided for eligible patients who were still receiving treatment at the time of the previous study’s closure.

The treatment continues as long as there is a perceived benefit, as assessed by the investigator.

4 safety and survival follow-up

For patients from the IMpower133 study who do not continue treatment, safety and survival follow-up is conducted.

The follow-up includes monitoring for serious adverse events and adverse events of special interest, with severity determined according to established criteria.

5 study completion

The study is estimated to end by March 6, 2030. The duration of participation may vary depending on individual circumstances and the investigator’s assessment.

Who Can Join the Study?

  • The patient must have cancer. Future studies might include other types of cancer not currently listed.
  • The patient should be eligible to continue or switch to atezolizumab-based therapy at the time the original study ends. Atezolizumab is a type of medication used in cancer treatment.
  • If the patient is using a comparator agent (another treatment being compared in the study), they must be eligible to continue it in a study sponsored by Genentech or Roche, and not have access to this treatment outside the study.
  • The first dose of the study treatment in the new study must be received within 7 days after the allowed break from the original study treatment.
  • The patient must still be benefiting from the atezolizumab-based treatment or the comparator treatment when the original study ends, as determined by the study doctor.
  • The patient must be able to follow the new study’s requirements, according to the study doctor’s judgment.
  • Women who can have children must have a negative pregnancy test within 7 days before starting the study treatment.
  • For patients from the IMpower133 study who are not continuing treatment in the new study: They must have stopped the atezolizumab-based therapy in the IMpower133 study and be in the follow-up phase when the IMpower133 study ends.
  • For patients from the IMpower133 study who are not continuing treatment in the new study: They must be eligible to continue or switch to atezolizumab-based therapy according to the IMpower133 study rules and have access to atezolizumab outside the new study when the IMpower133 study ends.
  • The study is open to both men and women.
  • The study includes people who might be considered vulnerable, meaning they might need extra protection or care.

Who Cannot Join the Study?

  • Patients who are not currently receiving the study treatment at the time of the parent-study closure.
  • Patients who have access to the study treatment locally, meaning they can get the treatment outside of 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
Institut Gustave Roussy Villejuif France

Other Sites

Site Name City Country Status
Krankenhaus Nord Klinik Floridsdorf Vienna Austria
Virgen del Rocío University Hospital Sevilla Spain
Semmelweis University Budapest Hungary
Tuedogyogyintezet Toeroekbalint Torokbalint Hungary
Stadt Wien Wiener Gesundheitsverbund Vienna Austria
Fakultni Thomayerova nemocnice Prague Czechia
Auaaijzdwf Pidetgfz Hugvyiyq De Mlyfsojqe Marseille France
Nxvsfzgy Invgtcsq Oxzqgvhmx Ikr Mvezn Sqdfvosmimdjgwidahqcrtrvllsc Imhgkxrr Bekxisrq Cracow Poland

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
29.09.2017
Czechia Czechia
Not recruiting
29.09.2017
France France
Not recruiting
29.09.2017
Hungary Hungary
Not recruiting
29.09.2017
Poland Poland
Not recruiting
29.09.2017
Spain Spain
Not recruiting
29.09.2017

Trial locations

Investigated drugs:

Atezolizumab is a medication used in this clinical trial. It is an immunotherapy drug that helps the body’s immune system fight cancer. Atezolizumab works by blocking a protein that prevents the immune system from attacking cancer cells, allowing the immune system to better target and destroy these cells. This trial aims to provide continued access to atezolizumab for patients who were already receiving it in a previous study.

Investigated diseases:

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells in the body. These cells can invade nearby tissues and form tumors, which may disrupt normal bodily functions. As cancer progresses, it can metastasize, meaning it spreads to other parts of the body through the blood or lymphatic system. The progression of cancer varies depending on the type and location of the cancer, as well as individual factors such as genetics and lifestyle. Some cancers grow slowly and may not cause symptoms for a long time, while others can be aggressive and spread quickly. The impact of cancer on the body can lead to a range of symptoms, including fatigue, weight loss, and pain, depending on the organs affected.

Trial ID:
2023-506186-57-00
Protocol code:
BO39633
Trial Phase:
Therapeutic confirmatory (Phase III)

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