BridgeMD
An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B)
EU CTIS ID: 2023-506184-34-00
What this study is testing
To provide continued treatment with atezolizumab-based therapy and/or combination/comparator agent(s) for eligible patients still on study treatment at the time of roll-over from the parent study 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
- Signed extension study Informed Consent Form
- Eligible for continuing atezolizumab-based therapy at the time of rollover from the parent study, as per the parent study protocol or
- Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
- Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
- Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator
- Able to comply with this extension study, in the investigator's judgment
You likely can't join if
- Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrolment in this extension study
- Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
- 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 this 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 this extension study (if applicable) Exception: Patients who permanently discontinued atezolizumab from parent studies that permit patients to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study.
- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
- Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
See the full eligibility criteria
Who can join
- Signed extension study Informed Consent Form
- Eligible for continuing atezolizumab-based therapy at the time of rollover from the parent study, as per the parent study protocol or
- Eligible for continuing the comparator agent(s) in a Genentech- or Roche-sponsored study as per the parent study protocol, with no access to commercially available comparator agent
- Time between the last dose of treatment received in parent study and first dose in extension study is no longer than the interruption period allowed in the parent study. First dose of study treatment in this extension study will be received within 7 days of the treatment interruption window allowed by the parent study
- Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of roll-over from the parent study as assessed by the investigator
- Able to comply with this 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
- Will comply with contraception criteria
What rules you out
- Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrolment in this extension study
- Study treatment or comparator agent is commercially marketed in the patient's country for the patient-specific disease and is accessible to the patient
- 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 this 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 this extension study (if applicable) Exception: Patients who permanently discontinued atezolizumab from parent studies that permit patients to continue treatment with the combination agent(s) alone after permanently discontinuing atezolizumab are eligible to enroll in this study.
- Ongoing serious adverse event(s) that has not resolved to baseline level or Grade ≤1 from the parent study or during the time between the last treatment in the parent study and the first dose of study treatment in this extension study
- Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
- Pregnant or lactating, or intending to become pregnant during this extension study and for the period after the last dose of study treatment specified in the designated RSI
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong
- Brazil
- Mexico
- Australia
- United Kingdom
- Canada
- Thailand
- Russian Federation
- Chile
- Ukraine
- Taiwan
- Switzerland
- United States
- Guatemala
- Korea, Republic of
- Singapore
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 Hong Kong; Brazil; Mexico; Australia; United Kingdom; Canada and 10 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.