Active not recruitingPHASE3INTERVENTIONAL

A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)

This study, called IMbrella A, offers a way for cancer patients already taking certain medicines, Atezolizumab or Bevacizumab, in an ongoing Genentech or Roche study, to continue their treatment. If their original study ends and they can't get their medication locally, this 'extension' study provides continued access. It's designed to let patients keep receiving their treatment as long as it's helping them, or until specific reasons, like the disease getting worse or side effects, mean they should stop. The aim is to ensure patients who are benefiting from these treatments can keep taking them safely and for as long as needed.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

382

Start

20 Sep 2017

Estimated completion

06 Mar 2030

Cancer

What is this study about?

This study is an 'extension study' for people with cancer who are already taking part in another clinical trial sponsored by Genentech or Roche. Think of it like this: if you're in a study taking a new cancer medicine, and that original study is coming to an end, this new study allows you to keep getting that medicine. This is especially helpful if the medicine isn't yet widely available in your area. The main goal is to make sure patients who are benefiting from these specific treatments (like Atezolizumab or Bevacizumab) can continue receiving them without interruption.

The study is 'open-label,' which means both you and your doctors will know which treatment you are receiving. It's also 'non-randomized,' meaning you won't be put into different groups by chance; you're continuing the treatment you were already on. The medicine and how often you receive it will generally be the same as in your previous study. This study allows for long-term observation to see how patients do over a longer period.

You can continue in this extension study as long as the treatment is still helping you, as decided by your doctor, or until other reasons make it necessary to stop. These reasons could include the cancer getting worse, experiencing serious side effects, becoming pregnant, or if you decide you no longer want to participate. This study is crucial for providing continued access to beneficial treatments and allows doctors to gather more information on their long-term effects.

Key takeaways

Allows continued access to specific cancer treatments (Atezolizumab, Bevacizumab) after a previous study ends.
Aimed at patients whose current treatment is still beneficial but not locally available.
Treatment plan and dosage generally remain the same as in the original study.
Involves ongoing monitoring for effectiveness and side effects.
Patients can continue as long as the treatment is helping, or until specific criteria are met.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

Generally, to join this study, you must already be a patient in another cancer study sponsored by Genentech or Roche, and be receiving either Atezolizumab, Bevacizumab, or a comparison medicine. A key requirement is that your original study is ending, and you can't get your current study medication through regular means in your local area. Your doctor must also believe that the treatment you are currently receiving is still helping you.

For women who could become pregnant, you would need to have a negative pregnancy test shortly before starting treatment in this study. You would also need to start treatment in this extension study fairly quickly (within 7 days) after your original study ends to ensure there's no major break in your treatment.

You would not be able to join this study if you already have reasons to stop your treatment, as outlined in your original study. Also, if the study medicine you are taking is already widely available to buy or get through standard healthcare (commercially available), you would likely not be eligible for this extension study.

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 taking Atezolizumab, Bevacizumab, or a comparison drug in another Genentech or Roche cancer study?
Is your current study ending soon, and you can't get your treatment locally?
Does your doctor think your current treatment is still helping your cancer?
For women, are you able to have a negative pregnancy test if needed?
Have you started or will you start treatment in this new study within 7 days of your old study finishing?

Answer every question to see your result.

What does participation involve?

If you join this study, you will continue to receive the same cancer treatment (Atezolizumab or Bevacizumab, or a comparison medicine) that you were receiving in your previous Genentech or Roche study. The amount of medicine you get and how often you get it will stay the same as in your earlier study. You'll have regular visits with your study doctor for assessments, which will include checks to see how the treatment is working and to monitor for any side effects.

You can continue receiving treatment in this study for an extended period, as long as your doctor believes it's still beneficial for you, or until your cancer progresses, you experience unacceptable side effects, or you decide to stop. The study also involves long-term observation, meaning doctors will keep an eye on your health and progress over time. The total duration of your participation could be several months to even a few years, depending on your individual response and circumstances.

Potential risks and benefits

The main benefit of joining this study is that it allows you to continue receiving a specific cancer treatment that you were getting in a previous study if that treatment isn't otherwise available to you. This means you could potentially continue to experience any positive effects of the treatment for longer. As with any medicine, there are potential risks and side effects, and these would be similar to those you experienced in your original study. Your doctors and the study staff will carefully monitor you for any side effects and will discuss these with you. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (170)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

HonorHealth Research Institute ? Bisgrove
Verified postcode
Scottsdale, United States
Angeles Clinic & Rsch Inst
Verified postcode
Los Angeles, United States
UCLA
Verified postcode
Los Angeles, United States
Kaiser Permanente - San Diego (Zion Ave)
Verified postcode
San Marcos, United States
University Of Colorado
Verified postcode
Aurora, United States
Rocky Mountain Cancer Ctr - Denver (Williams)
Verified postcode
Denver, United States
Smilow Cancer Hospital at Yale New Haven
Verified postcode
New Haven, United States
Georgetown University Medical Center Lombardi Cancer Center
Verified postcode
Washington D.C., United States
Florida Cancer Specialists - Fort Myers (Broadway)
Verified postcode
Fort Myers, United States
Hematology Oncology Associates of the Treasure Coast
Verified postcode
Port Saint Lucie, United States
Florida Cancer Specialists.
Verified postcode
St. Petersburg, United States
H. Lee Moffitt Cancer Center and Research Inst.
Verified postcode
Tampa, United States

Common questions

What is the main purpose of this study?

The main purpose is to allow cancer patients already taking specific medicines in another study to continue their treatment if their original study ends and they can't get the medicine elsewhere.

What treatments are involved?

The treatments are Atezolizumab or Bevacizumab, or other comparison medicines you might have been taking in your previous study.

How long will I be in the study?

You can stay in the study as long as the treatment is helping you, or until your doctor advises you to stop, or if you decide to withdraw.

Will I know which treatment I am getting?

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

Can I stop participating at any time?

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