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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
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

May 9, 2017
May 11, 2017
October 30, 2018
September 20, 2017
August 5, 2027   (Final data collection date for primary outcome measure)
Number of Participants With Continued Access to Atezolizumab-Based Therapy and/or Comparator Agent(s) [ Time Frame: Day 1 up to maximum 10 years ]
Same as current
Complete list of historical versions of study NCT03148418 on ClinicalTrials.gov Archive Site
  • 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) ]
  • 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 to Death due to any Cause [ Time Frame: Day 1 until death due to any cause (up to maximum 10 years) ]
Not Provided
Not Provided
 
A Study in Participants Previously Enrolled in a Genentech− and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
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
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 according 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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cancer
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
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.
Intervention: Drug: Atezolizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
546
215
August 5, 2027
August 5, 2027   (Final data collection date for primary outcome measure)

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 the treatment interruption period 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 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

Sexes Eligible for Study: All
Child, Adult, Older Adult
No
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
Australia,   Belgium,   Canada,   Chile,   Czechia,   France,   Georgia,   Germany,   Hungary,   Italy,   Japan,   Korea, Republic of,   Netherlands,   New Zealand,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovenia,   Spain,   Taiwan,   Thailand,   Turkey,   United Kingdom,   United States
 
 
NCT03148418
BO39633
2016-005189-75 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP