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NCT Number: NCT03768063

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

This is an open-label, multicenter, extension study. Patients who are receiving clinical benefit from atezolizumab monotherapy or atezolizumab in combination with other agent(s) or combination/comparator agent(s) during participation in a Genentech or Roche-sponsored study (the parent study), who are eligible to continue treatment and who do not have access to the study treatment locally, may continue to receive study treatment in this extension study following roll-over from the parent study.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Vincent'S Hospital, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible for continuing atezolizumab-based therapy at the time of roll-over 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
  • Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
  • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating eggs
  • For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Exclusion criteria

  • Meet any of the study treatment discontinuation criteria specified in the parent study at the time of enrollment 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 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: Participants who permanently discontinued atezolizumab from parent studies that permit participants 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 referenced safety information (RSI)

Treatment and study plan

Atezolizumab

Drug

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).

Other names: Tecentriq

Bevacizumab

Drug

Bevacizumab will be administered as directed per the parent study.

Other names: Avastin

Alectinib

Drug

Alectinib will be administered as directed per the parent study.

Other names: Alecensa

Cobimetinib

Drug

Cobimetinib will be administered as directed per the parent study.

Other names: Cotellic

Vemurafenib

Drug

Vemurafenib will be administered as directed per the parent study.

Other names: Zelboraf

FAP IL2V

Drug

FAP IL2V will be administered as directed per the parent study.

Other names: simlukafusp alfa

Venetoclax

Drug

Venetoclax will be administered as directed per the parent study.

Other names: Venclexta

Enzalutamide

Drug

Enzalutamide will be administered as directed per the parent study.

Other names: Xtandi

Pembrolizumab

Drug

Pembrolizumab will be administered as directed per the parent study.

Other names: Keytruda

Sunitinib

Drug

Sunitinib will be administered as directed per the parent study.

Other names: Sutent

Niraparib

Drug

Niraparib will be administered as directed per the parent study.

Other names: Zejula

Cabozantinib

Drug

Cabozantinib will be administered as directed per the parent study.

Other names: Cometriq

Pemetrexed

Drug

Pemetrexed will be administered as directed per the parent study.

paclitaxel

Drug

Paclitaxel will be administered as directed per the parent study.

Emactuzumab

Drug

Emactuzumab will be administered as directed per the parent study.

Rucaparib

Drug

Rucaparib will be administered as directed per the parent study.

Primary outcomes

  1. 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 outcomes

  1. Percentage of Participants With Serious Adverse Events (SAEs) According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Time frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)

  2. Percentage of Participants With Adverse Events of Special Interest Determined According to NCI CTCAE Version 5.0

    Time frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)

  3. Treatment Duration

    Time frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)

  4. Total Dose Received

    Time frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)

  5. Number of Treatment Cycles

    Time frame: Day 1 up to 90 days after last dose of study treatment (last dose=until 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)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

An Open Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella B)

Acronym: IMbrella B

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Dec 7, 2018
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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