Active not recruitingPHASE1INTERVENTIONAL

A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers

This research study is testing a new medication called inavolisib. It's being studied on its own, and also in combination with another drug called atezolizumab. The main goal is to find out if these treatments are safe and if they can help people who have certain cancers with a specific genetic change, known as a PIK3CA mutation. This includes individuals with head and neck cancer that has come back or spread and has already been treated. The study is in an early stage (Phase 1), meaning it's focusing on understanding safety and proper doses. By studying these drugs, researchers hope to find new ways to treat these types of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

Hoffmann-La Roche

Enrolment target

Start

11 Dec 2023

Estimated completion

21 Jul 2027

PIK3CA-Mutated Cancers

What is this study about?

This study is an early-stage (Phase 1) clinical trial looking into new ways to treat certain cancers. It focuses on cancers that have a specific genetic change called a 'PIK3CA mutation'. This mutation is like a small error in the cancer cell's instruction manual that can make it grow. The researchers are testing a medication called inavolisib, sometimes given alone, and sometimes together with another drug called atezolizumab.

Inavolisib works by targeting the specific faulty pathway controlled by the PIK3CA mutation. Atezolizumab is an immunotherapy, which helps your body's immune system fight cancer. By combining these two approaches, researchers hope to find a more effective treatment. This particular study is especially interested in people with head and neck cancer that has come back or spread after previous treatments.

The main aim of this early phase study is to check how safe these drugs are and to work out the best doses. While the study is also looking for signs of whether the treatments are effective at shrinking tumours or stopping their growth, the primary focus at this stage is safety. Information gathered from this study will help decide if these treatments should be studied further in larger groups of patients.

Key takeaways

This is an early-stage study for certain cancers with a PIK3CA mutation.
It tests a new drug called inavolisib, sometimes with another drug called atezolizumab.
The main goal is to check for safety and find the right dose.
It's open to people with head and neck cancer that has returned or spread, and who have had previous treatments.
You will have regular hospital visits, blood tests, and scans.
Joining is voluntary, and you can stop at any time.

Who may be eligible?

To join this study, you would need to have certain types of cancer with a specific genetic change (a PIK3CA mutation) that has been confirmed by a test. This includes head and neck cancer that has come back or spread after you've already had other treatments, and if surgery or radiation isn't suitable for you at this time. You'd also need to be generally well enough to take part and have specific health test results.

There are also reasons why you might not be able to join. For example, if you've already had certain types of cancer treatment that work in a similar way to the drugs being tested, or if you have certain health conditions like specific types of diabetes that require ongoing treatment. If you have active brain tumours that are causing symptoms, or are suitable for surgery or radiation now, you might not be able to join either. The study team will review all your medical information carefully to see if you're a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Have I been diagnosed with cancer that has a PIK3CA mutation?
Do I have head and neck cancer that has come back or spread, and have I already had treatment for it?
Am I generally well enough to take part in a study, as judged by my doctor?
Is surgery or radiation not an option for me right now?
Have I had certain other cancer treatments in the past, or do I have certain types of diabetes or other health conditions?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either inavolisib on its own or inavolisib combined with atezolizumab. The study involves regular visits to the hospital or clinic for assessments. These visits will include physical examinations, blood tests, and scans (like CT scans) to check how you are responding to the treatment and to monitor for any side effects. You will need to provide tissue samples for testing, including possibly a fresh tumour sample. The exact number of visits and tests will depend on the specific part of the study you are in and how you respond to the treatment. Typically, you would continue treatment and monitoring for as long as it is helping you and not causing unacceptable side effects. There would also be follow-up appointments after you stop active treatment.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available, and helping advance medical knowledge that could benefit others in the future. However, there are also potential risks, including side effects from the study drugs that could be mild or serious. The drugs may not work for your cancer, or they may not work as well as expected. The research team will discuss all known and potential risks with you in detail. Remember, joining a study is always voluntary, and you have the right to withdraw at any time, for any reason, without affecting your future medical care.

Locations (5)

Vanderbilt-Ingram Cancer Ctr
Verified postcode
Nashville, United States
BC Cancer Vancouver Centre
Verified postcode
Vancouver, Canada
Princess Margaret Cancer Center
Verified postcode
Toronto, Canada
Jewish General Hospital
Verified postcode
Montreal, Canada
Samsung Medical Center
Verified postcode
Seoul, South Korea

Common questions

What is a PIK3CA mutation?

It's a specific genetic change (a small error) found in some cancer cells that can make them grow and spread. This study is for cancers with this particular change.

What are inavolisib and atezolizumab?

Inavolisib is a new drug designed to target the PIK3CA mutation. Atezolizumab is an immunotherapy, which helps your body's immune system fight cancer.

What does 'Phase 1 study' mean?

It's an early stage of research. The main goals are to check if the new drugs are safe, understand their side effects, and find the best dose, rather than primarily looking at how effective they are.

Who is funding this study?

This study is sponsored by a pharmaceutical company called Genentech, Inc. (a member of the Roche Group).

Will I get 'dummy' treatment (placebo)?

Based on the description, it appears all participants will receive active treatment with either inavolisib alone or in combination with atezolizumab. There is no mention of a placebo arm in the brief summary provided.