An open label, multicenter extension study in patients previously enrolled in a Genentch and/or F. Hoffmann-La Roche Ltd sponsored atezolizumab study (IMBRELLA B) - IMBRELLA B

F. HOFFMANN - LA ROCHE LTD.0 个研究点目标入组 1,000 人开始时间: 2021年1月22日最近更新: 2021年8月30日

适应症

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•Patients must meet the following criteria for study entry:
•Signed extension study Informed Consent Form
•Eligible for continuing atezolizumab-based therapy at the time of roll-over from the parent study, as per the parent study protocol
•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
•Able to comply with this extension study, in the investigator’s judgment
•Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
•Will comply with contraception criteria
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 500
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 500

•Patients who meet any of the following criteria will be excluded from study entry:
•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
•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)
•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 RSI

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