Extension Study for Continued Treatment in Cancer Patients Using Atezolizumab, Tiragolumab, Ipatasertib, and Abiraterone or Drug Combination

The primary objective of this study is to provide continued treatment with **Roche investigational medicinal product (IMP)**-based therapy and/or comparator agent(s) for eligible participants with cancer who are still on study treatment at the time of roll-over from the parent study and who do not have access to the study treatment locally. This is clinically relevant as it ensures that patients who have been benefiting from a specific treatment regimen in a previous study can continue to receive potentially life-extending or quality-of-life-improving therapies, which they might not otherwise have access to outside of the clinical trial setting.

Secondary objectives include evaluating the safety and tolerability of the study treatment based on the incidence, nature, and severity of selected adverse events as described in investigational medicinal product-specific appendices. This assessment is crucial for understanding the risk profile of the treatment and ensuring patient safety during the extended use of the investigational therapies.

The clinical trial involves a total of **61 participants** who are part of an extension study designed to provide continued treatment for eligible patients with **cancer**. The study population includes both male and female subjects, encompassing an age range that corresponds to categories 3 and 4, which typically include adults and older adults. Participants were selected based on their previous enrollment and treatment in a Genentech/Roche study, known as the parent study, and their lack of access to the treatment locally. The trial includes a vulnerable population, indicating that special considerations are in place to ensure their safety and well-being. Participants are required to have the ability to comply with the extension study protocol, as judged by the investigator. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data. Key inclusion criteria include eligibility for continuing Roche investigational medicinal product-based therapy or comparator agent(s) from the parent study, with the first dose in this extension study to be received within seven days of the treatment interruption window allowed by the parent study. The study ensures that participants continue to benefit from the therapy without experiencing unacceptable toxicity or symptomatic deterioration attributed to disease progression.

The clinical trial is designed as an **open-label**, multicenter extension study aimed at providing continued treatment for eligible patients with cancer who were previously enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd sponsored study. The trial will include patients who do not have access to the treatment locally. The primary objective is to ensure continued access to Roche investigational medicinal product (IMP)-based therapy and/or comparator agents for participants who are still benefiting from the treatment at the time of roll-over from the parent study. The trial is expected to run until March 2033, with recruitment starting in April 2023.

The trial involves several key elements of research methodology, including the administration of **atezolizumab**, **abiraterone**, **tiragolumab**, and **ipatasertib**. These agents will be administered through various routes such as intravenous (IV) or subcutaneous (SC) infusion and oral administration, depending on the specific product. The trial will not be randomized or blinded, as it is an extension study focusing on continued treatment rather than initial efficacy assessment.

Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to confirm eligibility based on criteria such as continued benefit from the treatment, absence of unacceptable toxicity, and a negative urine pregnancy test for women of childbearing potential. Follow-up visits will be scheduled to monitor the incidence, nature, and severity of adverse events, as well as to ensure the continued efficacy of the treatment. The end-of-study visit will conclude the participant's involvement, provided they have not experienced disease progression or unacceptable toxicity.

The expected length of participant involvement is up to 120 days, with conditions for early termination including symptomatic deterioration attributed to disease progression or the occurrence of unacceptable toxicity. Participants must receive the first dose of study treatment within seven days of the treatment interruption window allowed by the parent study. The trial will focus on the primary endpoint of the number of participants with continued access to Roche IMP(s)-based therapy and/or comparator agent(s), with secondary endpoints assessing the safety profile of the treatments.

The clinical trial involves the administration of several investigational medicinal products. **Tecentriq** (atezolizumab) is provided as a 1,200 mg concentrate for solution for infusion. It is administered either **intravenously (IV)** or **subcutaneously (SC)**. The maximum daily dose is 1,875 mg, with a total maximum dose of 326.25 g over a treatment period of up to 120 days. The pharmaceutical form is a solution for infusion, and the product is manufactured by Roche Registration GmbH.

**Abiraterone** is administered in tablet form, with a maximum daily dose of 1,000 mg and a total maximum dose of 3,650 g over the same treatment period. The route of administration is **oral**. This product is classified as a chemical substance and is not a pediatric formulation.

**Tiragolumab** is another investigational product, provided as a concentrate for solution for infusion. It is administered via **IV infusion**. The maximum daily dose is 600 mg, with a total maximum dose of 104.4 g over 120 days. The product is developed by F. Hoffmann-La Roche Ltd and is not intended for pediatric use.

**Ipatasertib** is available in two formulations, both as film-coated tablets. Each formulation has a maximum daily dose of 400 mg and a total maximum dose of 1,460 g over the treatment period. The route of administration is **oral**, and the product is classified as an **AKT inhibitor**. Both formulations are developed by F. Hoffmann-La Roche Ltd and are not pediatric formulations.

Participant compliance with the dosing schedule is monitored throughout the trial. The investigational products are administered according to the specified routes and dosages, ensuring adherence to the study protocol. No additional non-experimental treatments, such as standard-of-care therapy or placebo, are specified in the trial data provided.

Efficacy in this clinical trial will be assessed primarily by evaluating the number of participants with continued access to Roche investigational medicinal product (IMP)-based therapy and/or comparator agent(s). This primary endpoint will provide insight into the sustained availability and utilization of the treatment regimen for eligible participants with cancer who are transitioning from a parent study. The secondary endpoint will focus on the incidence, nature, and severity of selected adverse events, as detailed in the IMP-specific appendices. These endpoints will be measured and analyzed to determine the efficacy and safety profile of the treatment regimen. The trial is designed to ensure that participants who continue to benefit from the Roche IMP-based therapy or comparator, as assessed by the investigator, can maintain their treatment regimen in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression. The study will be conducted over a maximum treatment period of 120 days, with the first dose of study treatment in this extension study to be received within 7 days of the treatment interruption window allowed by the parent study.