Clinical Trials /

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

NCT03148418

Description:

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.

Related Conditions:
  • Hematopoietic and Lymphoid Malignancy
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study in Participants Previously Enrolled in a Genentech− and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)
  • Official Title: An Open-Label, Multicenter Extension Study in Patients Previously Enrolled in a Genentech− and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study

Clinical Trial IDs

  • ORG STUDY ID: BO39633
  • SECONDARY ID: 2016-005189-75
  • NCT ID: NCT03148418

Conditions

  • Cancer

Interventions

DrugSynonymsArms
AtezolizumabRO5541267Atezolizumab

Purpose

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) 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. Study treatment in the extension study can continue until disease progression or beyond if the participant continues to derive clinical benefit in the judgment of the investigator and if allowed by the parent study or local prescribing information, death, withdrawal of study consent, unacceptable toxicity, pregnancy, participant non-compliance, or study termination by the Sponsor, whichever occurs first.

Trial Arms

NameTypeDescriptionInterventions
AtezolizumabExperimentalParticipants 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.
  • Atezolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  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

          -  Will comply with contraception criteria detailed in the designated Referenced Safety
             Information (RSI)

          -  Negative serum pregnancy test within 7 days prior to start of study treatment in women
             of childbearing potential

        Exclusion Criteria:

          -  Meet of any of the study treatment discontinuation criteria specified in the parent
             study at the time of enrollment in the extension study

          -  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 study treatment 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

          -  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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Time to Death due to any Cause
Time Frame:Day 1 until death due to any cause (up to maximum 10 years)
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Hoffmann-La Roche

Last Updated

January 19, 2018