A Study in Participants Previously Enrolled in a Genentech− and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
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| ClinicalTrials.gov Identifier: NCT03148418 |
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Recruitment Status :
Recruiting
First Posted : May 11, 2017
Last Update Posted : October 8, 2019
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Brief Summary:
This is an open-label, multicenter, non-randomized extension and long-term observational study. Participants receiving atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) and who continue to receive study treatment at the time of the parent-study closure are eligible for continued treatment in the extension study. Dosing regimen for a given participant and indication will be the same or equivalent to the respective parent study protocol. Study treatment in the extension study can continue until disease progression or beyond if the patient continues to derive clinical benefit as judged by the investigator and if allowed by the parent study or local prescribing information until death; withdrawal of study consent; unacceptable toxicity; pregnancy; patient non-compliance; or study termination by the Sponsor, whichever occurs first.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer | Drug: Atezolizumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 546 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Multicenter Extension and Long-Term Observational Study in Patients Previously Enrolled in a Genentech− and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study |
| Actual Study Start Date : | September 20, 2017 |
| Estimated Primary Completion Date : | August 5, 2027 |
| Estimated Study Completion Date : | August 5, 2027 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Atezolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Atezolizumab
Participants will continue to receive atezolizumab monotherapy or atezolizumab combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study) in accordance with local prescribing information till the participant continues to derive clinical benefit or until death, withdrawal of study consent, unacceptable toxicity, pregnancy, participant non-compliance, or study termination by the Sponsor, whichever occurs first.
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Drug: Atezolizumab
Atezolizumab will be administered as monotherapy or combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study). Dosing regimen will be in accordance with the parent study and local prescribing information.
Other Name: RO5541267 |
Primary Outcome Measures :
- Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) [ Time Frame: Day 1 up to maximum 10 years ]
Secondary Outcome Measures :
- Percentage of Participants With Serious Adverse Events (SAEs) by Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 [ Time Frame: Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) ]
- Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0 [ Time Frame: Day 1 up to 90 days after last dose of study treatment (last dose=till clinical benefit or until death, withdrawal of consent, unacceptable toxicity, pregnancy, non-compliance, or termination by Sponsor, whichever occurs first) (up to maximum 10 years) ]
- Time from Randomization or Treatment Initiation to Death due to any Cause [ Time Frame: Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years) ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
- 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
- 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
- Continue to benefit from atezolizumab-based study treatment or from the comparator at the time of parent-study closure as assessed by the investigator
- Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq) outside this extension study and continue safety and survival follow-up only in the extension study:
- Discontinuation of atezolizumab-based therapy in parent study and in survival follow up at the time of parent study closure, or eligible for continuing or crossing over to atezolizumab-based therapy as per the parent protocol and have access to commercially available atezolizumab (Tecentriq) outside this extension study at the time of the parent-study closure
Exclusion Criteria:
Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study:
- 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
- Time between the last dose of treatment received in parent study and first dose in extension study is longer than the interruption period (± 7 days) allowed in the parent 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
- Ongoing SAE(s) that has not resolved to baseline level or Grade less than or equal to (<=) 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
- Any serious uncontrolled concomitant disease that would contraindicate the use of study treatment at the time of the extension study or that would place the participant at high risk for treatment-related complications
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq) outside this extension study and continue safety and survival follow-up only in the extension study:
- Discontinuation of comparator in parent study and in survival follow-up at the time of parent study closure
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03148418
Contacts
| Contact: Reference Study ID Number: BO39633 www.roche.com/about_roche/ roche_worldwide.htm | 888-662-6728 (U.S. and Canada) | global-roche-genentech-trials@gene.com |
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT03148418 History of Changes |
| Other Study ID Numbers: |
BO39633 2016-005189-75 ( EudraCT Number ) |
| First Posted: | May 11, 2017 Key Record Dates |
| Last Update Posted: | October 8, 2019 |
| Last Verified: | October 2019 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Atezolizumab Antibodies, Monoclonal Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |