Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Trial of Ipatasertib in Combination With Atezolizumab

This research study is investigating two medicines, ipatasertib and atezolizumab, given together. It's for people with advanced solid tumours, including prostate cancer, or a specific type of brain tumour called glioblastoma. The study has two main parts: the first part focuses on finding the safest and most effective dose of the combined medicines, while the second part explores how well this dose works and how it affects the body in certain groups of patients. The main goal is to understand the safety and early effects of this combination treatment. If you have been diagnosed with one of these conditions, your doctor might discuss this study as a potential option.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Institute of Cancer Research, United Kingdom

Enrolment target

Start

13 Aug 2018

Estimated completion

01 Mar 2026

Solid Tumor Glioblastoma Multiforme Prostate Cancer Metastatic

What is this study about?

This study is an early-stage clinical trial looking into a new way to treat certain advanced cancers. It combines two different medicines: ipatasertib and atezolizumab. Ipatasertib works by targeting a specific pathway in cancer cells, trying to stop them from growing, while atezolizumab is an immunotherapy that helps your body's immune system fight the cancer. Researchers want to see if using these two medicines together is safe and if it can be an effective treatment for advanced solid tumours, including advanced prostate cancer, and glioblastoma, a type of brain tumour.

The study has been carefully designed in two main steps. The first step, which has now finished, involved a small number of patients and aimed to find the most suitable and safest dose of ipatasertib to be given alongside a standard dose of atezolizumab. This is really important for making sure future treatments are as safe as possible. Once the best dose was found, the study moved to its second step.

In the second step, more patients are being enrolled. This part of the study allows doctors to look more closely at how the combined treatment affects different groups of patients and to confirm its safety and early effectiveness. For some patients with solid tumours, doctors will check if their tumour has specific genetic changes that might make them more likely to respond to the treatment. For patients with glioblastoma, some may have surgery before starting the combined treatment.

Key takeaways

This is an early-stage study looking at a new combination of two cancer drugs.
It's for people with advanced solid tumours, including prostate cancer, or glioblastoma.
The study aims to understand safety and initial effectiveness.
Participation involves taking tablets and having infusions, with regular check-ups.
Your medical team will discuss all potential benefits and risks. you can leave any time.

Who may be eligible?

To be considered for this study, you would generally need to have an advanced solid tumour that has not responded to standard treatments, or for which there are no standard treatments available. This includes certain types of advanced prostate cancer. Alternatively, if you have a glioblastoma (a type of brain tumour), you might be eligible, especially if surgery to remove the tumour is planned or has recently happened.

Doctors will also check if your cancer can be measured or evaluated, which helps them see if the treatment is working. It's important that you are generally well enough to take part and can provide samples like blood tests or tumour tissue (biopsies) as part of the study requirements. For some parts of the study, specific genetic changes in your tumour might be needed.

Quick self-check

Have you been diagnosed with an advanced solid tumour (including prostate cancer) or glioblastoma?
Has your current cancer not responded to standard treatments, or are there no standard treatments available?
Are you generally well enough to participate in a clinical trial?
Are you able to provide blood samples and potentially tumour biopsies?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be taking two medications: ipatasertib, which is a tablet you take by mouth, and atezolizumab, which is given as an infusion into a vein. Before starting the full treatment, some patients will take ipatasertib for a couple of weeks on its own. For patients having surgery for glioblastoma, this initial phase will be followed by your operation, and then you'll start the combined treatment after you've recovered.

You will have regular hospital visits for assessments, which will include blood tests, physical examinations, and scans to monitor your health and how the treatment is affecting your cancer. These visits are important for the medical team to keep track of your progress and any side effects. You'll continue with the treatment and follow-up until your doctor determines it's no longer benefiting you, or if you decide to stop participating. The exact duration of your participation will depend on how you respond to the treatment.

Potential risks and benefits

Like all medical treatments, there are potential benefits and risks to consider. You might benefit from the treatment if the combination of medicines helps to shrink or control your cancer, potentially improving your quality of life. However, there's no guarantee the treatment will work for everyone, as this is an experimental approach. Potential risks include side effects from the medications, which your doctor will discuss in detail with you. These could vary and might include fatigue, nausea, or other reactions. Your safety and well-being are the top priority. You are always free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Royal Marsden Hospital NHS Foundation Trust
Sutton, United Kingdom

Common questions

What kind of cancers is this study for?

This study is for people with advanced solid tumours that haven't responded to standard treatments, or for which there are no standard options. It also includes certain advanced prostate cancers and a type of brain tumour called glioblastoma.

What are ipatasertib and atezolizumab?

Ipatasertib is a tablet that targets cancer growth pathways, and atezolizumab is an immunotherapy given into a vein, which helps your body's immune system fight cancer.

Will I have surgery if I join this study?

Only some patients with glioblastoma who are having surgery for their tumour might join one part of the study. Most patients will not have surgery as part of this trial.

What does a 'Phase 1' study mean?

Phase 1 studies are early studies that focus on finding the safest dose of a new treatment and seeing how the body reacts to it. They help doctors understand the treatment better before larger studies are done.

Can I stop participating in the study at any time?

Yes, you have the right to withdraw from the study at any point, for any reason, and this will not affect your usual medical care.