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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03148418




Registration number
NCT03148418
Ethics application status
Date submitted
9/05/2017
Date registered
11/05/2017
Date last updated
14/05/2024

Titles & IDs
Public title
A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
Scientific 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
Secondary ID [1] 0 0
2016-005189-75
Secondary ID [2] 0 0
BO39633
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Bevacizumab

Experimental: Atezolizumab Monotherapy - Participants will continue to receive atezolizumab monotherapy 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.

Experimental: Combined Agents with Atezolizumab - Participants will receive treatment of atezolizumab with combined agent(s) as directed per the parent study. Participants will receive agent(s) in combination with atezolizumab at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.

Active Comparator: Comparator Treatment - Participants will receive comparator treatment administration as directed per the parent study. Participants will receive comparator treatment at the same dose and schedule, and with the same administration guidelines that were in effect at the time of participant discontinuation from the parent study.


Treatment: Drugs: Atezolizumab
Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).

Treatment: Drugs: Bevacizumab
Bevacizumab will be administered as directed per the parent study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s)
Timepoint [1] 0 0
Day 1 up to maximum 10 years
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Percentage of Participants With Adverse Events of Special Interest by Severity Determined According to NCI CTCAE Version 4.0
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Time from Randomization or Treatment Initiation to Death due to any Cause for IMpower133 Participants Only
Timepoint [3] 0 0
Day 1 (as indicated in parent study protocol) until death due to any cause (up to maximum 10 years)

Eligibility
Key inclusion criteria
Specific criteria for patients who continue treatment as well as safety and survival
follow-up in the extension study (and survival follow up for pattients 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

- 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 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 and 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, or 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/03/2030
Actual
Sample size
Target
Accrual to date
Final
382
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Princess AleXandra Hospital; Department of Medical Oncology - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Arizona
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Liguria
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Piemonte
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Edirne
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Istanbul
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Sihhiye/Ankara
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Ukraine
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Podolia Governorate
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Ukraine
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Dnipropetrovsk
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United Kingdom
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Liverpool
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London
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Manchester
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Nottingham
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United Kingdom
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
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 and do
not have access to the study treatment locally 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03148418
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries