E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Malignancies |
Neoplasie avanzate |
|
E.1.1.1 | Medical condition in easily understood language |
Advanced Malignancies |
Neoplasie avanzate |
|
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 | 21.1 |
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064467 |
E.1.2 | Term | Urothelial carcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067946 |
E.1.2 | Term | Renal cell carcinoma |
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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065252 |
E.1.2 | Term | Solid tumor |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060121 |
E.1.2 | Term | Squamous cell carcinoma of head and neck |
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 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 |
Fornire un trattamento continuo con terapia a base di atezolizumab e/o agenti di confronto a pazienti idonei ancora sottoposti al trattamento dello studio al momento del passaggio dallo studio originario che non abbiano accesso al trattamento dello studio a livello locale. |
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E.2.2 | Secondary objectives of the trial |
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 |
Identificare qualsiasi nuovo segnale di sicurezza correlato ad atezolizumab o ad atezolizumab somministrato con agenti di associazione in pazienti idonei a ricevere il trattamento con atezolizumab e che abbiano dimostrato un beneficio clinico |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
I pazienti devono soddisfare i seguenti criteri di inclusione per poter essere ammessi allo studio: • Devono aver firmato il consenso informato allo studio di estensione • Devono essere idonei a continuare la terapia a base di atezolizumab al momento del passaggio dallo studio originario, come da protocollo dello studio originario oppure • Devono essere idonei a continuare gli agenti di confronto in uno studio sponsorizzato da Genentech o Roche come da protocollo dello studio originario, senza accesso ad agenti di confronto disponibili in commercio • Il periodo di tempo trascorso tra l'ultima dose di trattamento ricevuta nello studio originario e la prima dose nello studio di estensione non deve essere più lungo del periodo di interruzione consentito nello studio originario. La prima dose di trattamento dello studio in questo studio di estensione sarà somministrata entro 7 giorni dall'intervallo di interruzione del trattamento consentito dallo studio originario. • Devono continuare a trarre beneficio dal trattamento dello studio a base di atezolizumab o dal prodotto di confronto al momento del passaggio dallo studio originario secondo la valutazione dello sperimentatore • Devono essere in grado di rispettare quanto previsto in questo studio di estensione, a giudizio dello sperimentatore • Il test di gravidanza sul siero deve essere negativo nei 7 giorni precedenti all'inizio del trattamento dello studio nelle donne in età fertile • Devono rispettare i criteri di contraccezione. |
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E.4 | Principal 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 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 |
I pazienti che soddisfano uno qualsiasi dei seguenti criteri saranno esclusi dallo studio: • Soddisfazione di uno qualsiasi dei criteri di interruzione del trattamento dello studio specificati nello studio originario al momento dell'arruolamento in questo studio di estensione • Il trattamento dello studio o l'agente di confronto è immesso in commercio nel Paese del paziente per la malattia specifica del paziente ed è accessibile al paziente • Interruzione definitiva di atezolizumab per qualsiasi motivo durante lo studio originario o nel periodo tra l'ultimo trattamento nello studio originario e la prima dose del trattamento dello studio in questo studio di estensione (se applicabile) • Eventi avversi gravi in corso che non si sono risolti al livello basale o al Grado =1 dallo studio originario o nel periodo tra l'ultimo trattamento nello studio originario e la prima dose del trattamento dello studio in questo studio di estensione • Qualsiasi condizione che, secondo il parere dello sperimentatore, interferirebbe con l'interpretazione della sicurezza del paziente • Partecipazione concomitante a qualsiasi sperimentazione clinica terapeutica (diversa dallo studio originario) • Gravidanza, allattamento o intenzione di iniziare una gravidanza durante questo studio di estensione e nel periodo successivo all'ultima dose di trattamento di studio specificato nelle RSI designate |
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E.5 End points |
E.5.1 | 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. |
Pazienti che traggono beneficio clinico dal trattamento con terapia a base di atezolizumab e / o agenti di confronto secondo la valutazione dello sperimentatore. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the whole study. |
Durante tutto lo studio |
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E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Continued treatment with atezolizumab |
Trattamento continuativo con atezolizumab |
|
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 116 |
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 | Information not present in EudraCT |
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 |
Australia |
Brazil |
Canada |
Chile |
China |
Israel |
Korea, Republic of |
Malaysia |
Mexico |
Russian Federation |
Singapore |
Taiwan |
Thailand |
Turkey |
Ukraine |
United States |
Belgium |
Bulgaria |
Denmark |
France |
Germany |
Italy |
Latvia |
Netherlands |
Norway |
Poland |
Portugal |
Romania |
Slovakia |
Spain |
Switzerland |
United Kingdom |
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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
|
The end of this study is defined as the date when the last patient, last visit occurs, or if the Sponsor decides to terminate the study, whichever occurs first. |
La fine di questo studio corrisponde alla data in cui si verifica l'ultima visita dell'ultimo paziente o quella in cui lo sponsor decide di interrompere lo studio, a seconda di quale evento si verifichi per primo. |
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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 | 10 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 10 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |