Advanced Malignancies MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10064467 Term: Urothelial carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10067946 Term: Renal cell carcinoma System Or
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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 •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
Exclusion criteria
Exclusion criteria: 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 enrolment 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To provide continued treatment with atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of roll-over from the parent study who do not have access to the study treatment locally;Secondary Objective: To identify any new safety signal related to atezolizumab or atezolizumab administered with combination agent(s) in patients who are currently eligible to receive treatment with atezolizumab and have demonstrated clinical benefit;Primary end point(s): Patients who are deriving clinical benefit from the treatment with atezolizumab-based therapy and/or comparator agent(s) according to investigator assessment.;Timepoint(s) of evaluation of this end point: Throughout the whole study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Belgium, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Latvia, Netherlands, Norway, Poland, Romania, Singapore, Slovakia, Slovenia, Spain, United Kingdom, United States
Contacts
Public ContactAnne-Laure Choain
F. Hoffmann-La Roche Ltd
Outcome results
None listed