E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Cancer (Future parent protocols may include other cancer that are not included in this section) |
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E.1.1.1 | Medical condition in easily understood language |
Cancer is a disease with an uncontrolled growth of malignant cells in the body and ability of these cells to spread from original site to distant site |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10046721 |
E.1.2 | Term | Urothelial carcinoma bladder stage III |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029514 |
E.1.2 | Term | Non-small cell lung cancer NOS |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023400 |
E.1.2 | Term | Kidney cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To provide continued access to atezolizumab-based therapy and/or comparator agent(s) for eligible patients still on study treatment at the time of the parent-study closure |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the safety following exposure of atezolizumab monotherapy or atezolizumab administered with combined agent(s) - To evaluate overall survival following exposure of atezolizumab monotherapy or atezolizumab administered in combination with other agent(s) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study: - 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 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 parent-study closure as assessed by the investigator - Able to comply with the extension study, in the investigator's judgment - Will comply with contraception criteria detailed in BO39633 protocol - Negative serum pregnancy test within 7 days prior to start of study treatment in women of childbearing potential
2. Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available atezolizumab (Tecentriq®) outside this extension study and continue safety and survival follow-up only in the extension study: - Discontinuation of atezolizumab-based therapy in parent study and in survival follow up at the time of parent study closure or - Eligible for continuing or crossing over to atezolizumab-based therapy as per the parent protocol and have access to commercially available atezolizumab (Tecentriq®) outside this extension study at the time of the parent-study closure. |
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E.4 | Principal exclusion criteria |
1. Specific criteria for patients who continue treatment as well as safety and survival follow-up in the extension study: - Meet of 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 event(s) that has not resolved to baseline level or Grade <= 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 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
2. Specific criteria for patients who do not continue treatment in the extension study and/or receive commercially available Tecentriq®outside this extension study and continue safety and survival follow-up only in the extension study: - Discontinuation of comparator in parent study and in survival follow-up at the time of parent study closure |
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E.5 End points |
E.5.1 | Primary end point(s) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Incidence and severity of serious adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.0 2. Incidence and severity of adverse events of special interest, with severity determined according to NCI CTCAE, v4.0 3. Time from randomization or treatment initiation to death due to any cause |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-3. Throughout the study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 164 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Austria |
Belgium |
Bosnia and Herzegovina |
Brazil |
Bulgaria |
Canada |
Chile |
Czech Republic |
El Salvador |
France |
Georgia |
Greece |
Guatemala |
Hong Kong |
Hungary |
Israel |
Italy |
Japan |
Korea, Republic of |
Latvia |
Lithuania |
Mexico |
Netherlands |
New Zealand |
Panama |
Peru |
Poland |
Romania |
Russian Federation |
Serbia |
Singapore |
Slovakia |
Slovenia |
Spain |
Switzerland |
Taiwan |
Thailand |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of this study is defined as the date when the last patient, last visit (LPLV) occurs, safety follow-up is received from the last patient, or if the Sponsor decides to terminate the study, whichever occurs first. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 12 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 5 |
E.8.9.2 | In all countries concerned by the trial years | 12 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 5 |