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Continued Cancer Treatment Study with Abiraterone, Ipatasertib, Tiragolumab, and Drug Combination for Patients from Previous Genentech/Roche Trials

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on providing continued treatment for patients with cancer who were previously part of a study sponsored by Genentech or F. Hoffmann-La Roche Ltd. The study aims to offer ongoing access to specific treatments that patients may not have available locally. The treatments being studied include several medications: Abiraterone, Ipatasertib, Tiragolumab, and Tecentriq. These medications are used in various forms, such as tablets or infusions, to help manage cancer.

The purpose of this study is to ensure that patients who are benefiting from these treatments can continue to receive them. The study will follow patients who are still on their treatment regimen from a previous study and do not have access to these medications outside of the trial. The study will monitor the number of participants who continue to have access to these treatments and will also observe any side effects that may occur.

Participants in this study will receive their treatment over a period of up to 120 days. The medications will be administered either orally or through an infusion, depending on the specific treatment. This study is designed to help maintain the health and well-being of patients who have already shown positive responses to these treatments in earlier studies.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will continue the treatment you were receiving in the previous study. This is an extension study designed to provide continued treatment for eligible patients with cancer who were previously enrolled and treated in a Genentech/Roche study.
The first dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study.
Step 2
Treatment administration
You will receive continued treatment with Roche investigational medicinal product (IMP)-based therapy and/or comparator agent(s).
The medications involved in this study include abiraterone (oral film-coated tablet), ipatasertib (oral film-coated tablet), tiragolumab (solution for infusion), and atezolizumab (intravenous or subcutaneous).
The specific dosage, frequency, and duration of administration will be determined by the study protocol and your healthcare provider.
Step 3
Monitoring and assessments
Throughout the study, your health will be closely monitored. This includes regular assessments to evaluate the benefits of the treatment and to check for any side effects.
The incidence, nature, and severity of any adverse events will be recorded and assessed.
Step 4
End of study participation
The study is estimated to end by March 1, 2033. Your participation may continue until this date or until you no longer benefit from the treatment, as assessed by your healthcare provider.
Your participation will also end if you experience unacceptable side effects or if your condition worsens.

Who can join the trial?

5 criteria

The patient must be eligible to continue with the **Roche investigational medicinal product (IMP)**-based therapy or the **comparator agent** from the previous study, according to the rules of that study.
The first dose of the study treatment in this extension study must be received within **7 days** of the allowed break from the previous study's treatment.
The patient must still be benefiting from the Roche IMP-based therapy or comparator at the time of joining this study, as determined by the study doctor. This means the patient should not have any unacceptable side effects or worsening symptoms due to the disease, based on a review of medical images, biopsy results (if available), and overall health.
Women who can have children must have a **negative urine pregnancy test** within 24 hours before receiving the first dose of the study treatment.
The patient must be able to follow the rules and requirements of the extension study, as judged by the study doctor.

Who cannot join the trial?

2 criteria

Patients who have not previously participated in a Genentech/Roche study related to this treatment.
Patients who have access to the study treatment locally and do not need to continue in this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
Responsive
CHRU De Nancy
Vandoeuvre Les Nancy, France
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium

Trial locations

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Investigated drugs

Roche investigational medicinal product (IMP) is a type of treatment that is still being studied and is not yet available to the public. It is designed to help treat cancer by targeting specific parts of cancer cells or the environment around them. This medication is part of a research study to see how well it works and how safe it is for patients who have already been receiving it in a previous study. The goal is to continue providing this treatment to patients who are benefiting from it and do not have other ways to get it.

Tiragolumab

What is already known about the treatment

Roche investigational medicinal product (IMP) – This medication is administered as part of an extension study for patients with cancer who were previously part of a Genentech/Roche study and cannot access the treatment locally. The medication is still under investigation, meaning it is not yet fully approved for widespread use, but it is being provided to eligible patients to continue their treatment. It is primarily used for cancer therapy, aiming to help manage the disease in patients who have already been receiving this treatment. The exact mechanism of action at the molecular level is not specified, but it is part of ongoing research to determine its effectiveness and safety. This medication falls under the category of investigational cancer therapies, which are drugs being tested for their potential to treat cancer.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. It can develop in almost any organ or tissue, such as the lung, colon, breast, skin, bones, or nerve tissue. The progression of cancer involves stages, starting from a localized tumor that can invade nearby tissues. As it advances, cancer cells may spread to other parts of the body through the blood and lymph systems, a process known as metastasis. The rate of progression and the specific symptoms depend on the type and location of the cancer. Over time, cancer can affect the normal functioning of the body systems where it has spread.