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NCT Number: NCT05112965

An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C)

This is an open-label, multicenter, non-randomized extension 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), who are eligible to continue treatment and do not have access to the study treatment locally, continue to receive study treatment in this extension 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

Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China

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 or crossing over to 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
  • 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 rollover 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 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 serious adverse events that have 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 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 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 the extension study

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 at the time of participant discontinuation from the parent study closure.

Other names: Tecentriq

Bevacizumab

Drug

Bevacizumab will be administered as directed per the parent study.

Other names: Avastin

Pemetrexed

Drug

Pemetrexed will be administered as directed per the parent study.

paclitaxel

Drug

Paclitaxel will be administered as directed per the parent study.

Enzalutamide

Drug

Enzalutamide will be administered as directed per the parent study.

Other names: Xtandi

Primary outcomes

  1. Number of Participants With Continued Access to Atezolizumab-based Therapy and/or Comparator Agent(s)

    Time frame: Up to approximately 4 years

Secondary outcomes

  1. Percentage of Participants With Serious Adverse Events (SAEs)

    Time frame: Up to 90 days after the final dose of study treatment (up to approximately 4 years)

  2. Percentage of Participants With Adverse Events of Special Interest (AESIs)

    Time frame: Up to 90 days after the final dose of study treatment (up to approximately 4 years)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Nov 9, 2021
Registry last updated
Jul 6, 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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