Active not recruitingPHASE3INTERVENTIONAL

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

This study is for people with cancer who have been taking part in an earlier Genentech or Roche study and are benefiting from the treatment they’re receiving, whether it's atezolizumab on its own or in combination with other medicines. The main aim is to allow these patients to keep receiving their study treatment if they otherwise wouldn't have access to it in their local area. It’s like an extension, ensuring that if a treatment is working well for you in a trial, you can continue to get it, even when the original trial period ends. This helps patients maintain their treatment and continue to feel the benefits.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

1,000

Start

28 Feb 2019

Estimated completion

05 Jul 2028

Cancer

What is this study about?

This study is a continuation for some cancer patients who have already been taking part in another study sponsored by Genentech or Roche. If you're in one of those studies and the treatment you're receiving (which might include a medicine called atezolizumab) is really helping you, this new study aims to let you keep getting that same treatment. Think of it as a way to extend your treatment if it's working well and you wouldn't be able to get it any other way.

The main idea behind this study is to make sure that patients who are clearly benefiting from a trial treatment don't suddenly have to stop. Sometimes, after a main study ends, the specific treatment isn't available to patients in their local area, even if it's been very effective for them. This 'extension' study bridges that gap.

It’s designed to allow you to seamlessly continue with your current therapy, provided you're still doing well on it. This means you can keep receiving the medicine that's helping you manage your cancer, without interruption, and gives researchers more time to observe the long-term benefits in patients.

Key takeaways

It’s for cancer patients already in another study who are benefiting from their current treatment.
The main goal is to let you continue getting a helpful treatment if you can't get it locally.
You'll keep receiving the same medicine you were on in the previous study.
Both you and your doctor will know which treatment you are receiving.
You can leave the study at any time.
Strict rules apply regarding birth control for both men and women.

Who may be eligible?

To be considered for this study, you must already be enrolled in a Genentech or Roche-sponsored study involving atezolizumab or a comparison treatment, and importantly, your doctor needs to believe that the treatment is still helping you. You should not have stopped treatment permanently in the original study, and there shouldn't be long gaps between your last dose in the old study and your first dose in this new one. This study is specifically for those who can't get the treatment locally once the main study finishes.

There are also important considerations for women who could become pregnant and for men. Women must have a negative pregnancy test and agree to use effective birth control or avoid sex, and not donate eggs. Men must also agree to use birth control or avoid sex, and not donate sperm. This is standard practice in many clinical studies to ensure safety.

However, you won't be able to join if you've already had to stop your original study treatment for safety reasons, or if the treatment you're currently receiving is already available and accessible to you commercially in your country for your type of cancer. Also, you can't have started any other cancer treatments between your last dose in the previous study and the start of this one.

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.

Are you currently in a Genentech or Roche cancer study and benefiting from your treatment?
Is your doctor happy for you to continue your current study treatment?
Is your study treatment not available to you commercially in your country?
Have you ensured that women who could become pregnant are using effective birth control or avoiding sex, and men are doing the same or avoiding donating sperm?
Have you not received any other cancer treatments since your last dose in the previous study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the same study treatment you were getting in the previous Genentech or Roche study. The schedule for your treatment and check-ups will likely follow what you were doing before, though the doctors will explain any specific differences. You'll have regular visits to your clinic for your treatment and to allow the study team to monitor your health and how the treatment is working. This is an 'open-label' study, which means both you and your doctor will know which specific treatment you are receiving. The study aims to allow you to continue your treatment for as long as it benefits you, or until you meet any of the stopping criteria.

Potential risks and benefits

The potential benefits of joining this study include continuing to receive a cancer treatment that has already shown to be effective for you, especially if you wouldn't be able to access it otherwise. This means you could potentially keep managing your cancer with a therapy that is working. As with any medication, there are potential risks, and you might experience side effects from the treatments. These side effects should be similar to those you experienced or could have experienced in the original study, and the study team will monitor you closely for them. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (81)

University of Colorado Cancer Center
Verified postcode
Aurora, United States
Yale University School Of Medicine
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Trumbull, United States
Massachusetts General Hospital
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Boston, United States
Beth Israel Deaconess Medical Center
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Boston, United States
Carolina BioOncology Institute, PLCC
Verified postcode
Huntersville, United States
St. Luke's Cancer Care Associates
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Bethlehem, United States
University of Texas Health Sciences Center in San Antonio
Verified postcode
San Antonio, United States
St Vincent'S Hospital
Verified postcode
Darlinghurst, Australia
UZ Leuven
Verified postcode
Leuven, Belgium
Institut Jules Bordet
Verified postcode
Brussels, Belgium
UZ Brussel
Verified postcode
Brussels, Belgium
Hospital das Clinicas - UFRGS
Verified postcode
Porto Alegre, Brazil

Common questions

What is atezolizumab?

Atezolizumab is a type of cancer medicine, often called immunotherapy, that helps your body’s own immune system fight cancer cells.

Why is this an 'extension study'?

It's an extension because it allows patients who are already benefiting from a treatment in another study to continue receiving that treatment, rather than stopping when the first study ends.

Will I know what treatment I'm getting?

Yes, this is an 'open-label' study, meaning both you and your doctor will know exactly which treatment you are receiving.

What does 'commercially available' mean?

It means if the treatment is already approved and can be bought or prescribed by doctors outside of a clinical trial in your country.

Can I stop the study anytime I want?

Yes, you have the right to leave the study at any point, and it won't affect your regular medical care.