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An Extension and Long-Term Observational Study In Patients Previously Enrolled in a Genentech− and/Or F. Hoffmann-La Roche Ltd−Sponsored Atezolizumab Study
EU CTIS ID: 2023-506186-57-00
What this study is testing
To provide continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent-study closure and who do not have access to the study treatment locally
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Eligible for continuing or crossing over to atezolizumab-based therapy at the time of the parent-study closure as per the parent study or Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study at the time of the parent-study closure as per the parent study, with no access to commercially available comparator agent.
- Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): First dose of study treatment in the extension study will be received within 7 days of the treatment interruption window allowed by the parent study.
- Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator.
- Specific criteria for patients who continue treatment as well as safety follow-up in the extension study (and survival follow up for patients who roll over from IMpower133): Able to comply with the extension study, in the investigator’s judgment; Negative blood pregnancy test within 7 days prior to start of study treatment in women of childbearing potential.
- Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study but continue safety and survival follow-up only in the extension study: Discontinuation of atezolizumab-based therapy in the IMpower133 parent study and in survival follow-up at the time of IMpower133 parent study closure
- Specific criteria for patients from the IMpower133 parent study only who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study but continue safety and survival follow-up only in the extension study: Eligible for continuing or crossing over to atezolizumab-based therapy as per the IMpower133 parent protocol and have access to commercially available atezolizumab (Tecentriq®) outside this extension study at the time of the IMpower133 parent-study closure.
You likely can't join if
- Meet of any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment in the extension study
- Study treatment is commercially marketed in the patient’s country for the patient-specific disease and is accessible to the patient.
- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade<=1 from the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Treatment with any anti-cancer treatment (other than treatment permitted in the parent study) during the time between last treatment in the parent study and the first dose of study treatment in the extension study
- Permanent discontinuation of atezolizumab for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in the extension study (if applicable)
- Any unresolved or irreversible toxicities during the parent study that required permanent discontinuation of study treatment, in accordance to the parent study or local prescribing information
The study team makes the final eligibility decision.
Where it's taking place
- United States
- New Zealand
- Japan
- Argentina
- Ukraine
- Thailand
- Russian Federation
- Taiwan
- Canada
- Australia
- Brazil
- Korea, Republic of
- Chile
- Switzerland
- United Kingdom
- Israel
- Turkey
- Serbia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; New Zealand; Japan; Argentina; Ukraine; Thailand and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.