E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Any tumor type eligible for treatment with talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial |
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E.1.1.1 | Medical condition in easily understood language |
Any tumor type eligible for treatment with talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
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 evaluate the long-term safety of talimogene laherparepvec
• To monitor subject overall survival
• To monitor use of subsequent anti-cancer therapy, for the tumor indication in the prior Amgen or BioVEX-sponsored clinical trial, including retreatment with marketed talimogene laherparepvec in subjects previously enrolled in Amgen or BioVEX-sponsored clinical trials |
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E.2.2 | Secondary objectives of the trial |
There are no secondary objectives |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. All subjects must provide informed consent prior to initiation of any study activities. When the subject is legally too young to provide informed consent/assent, subject’s legally acceptable representative must provide informed consent/assent based on local regulations and/or guidelines prior to initiation of any study activities
2. All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial |
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E.4 | Principal exclusion criteria |
1. Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial
2. Subject currently participating, including for long-term follow-up (if applicable), in other Amgen-sponsored talimogene laherparepvec clinical trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Long-term safety as assessed by subject incidence of all talimogene laherparepvec treatment-related adverse events of any grade, grade ≥ 3 adverse events, serious adverse events, fatal adverse events, and adverse events of interest that begin after the defined reporting period has ended on the previous Amgen or BioVEX-sponsored talimogene laherparepvec clinical trial will be summarized. Treatment-related adverse events during the retreatment period with marketed talimogene laherparepvec and up to 30 days after the discontinuation of treatment will be reported separately.
• Survival status: Time to death will be calculated from the first dose of talimogene laherparepvec from the earliest parent study.
• Use of subsequent anti-cancer therapy for indicated tumor type in prior Amgen or BioVEX-sponsored talimogene laherparepvec clinical trial will be
summarized. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary analysis will be performed at the end of study. The registry study will end when the sponsor (in consultation with the regulatory authorities) has determined that the collection of long-term safety and survival data are no longer necessary. |
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E.5.2 | Secondary end point(s) |
There are no secondary endpoints |
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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 | 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) | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Observational registry study |
|
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 | 0 |
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 | 31 |
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 |
Austria |
Canada |
France |
Germany |
Greece |
Hungary |
Italy |
Netherlands |
Poland |
Russian Federation |
Spain |
Switzerland |
United Kingdom |
United States |
|
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 registry study will end when the sponsor (in consultation with the regulatory authorities) has determined that the collection of long-term safety and survival data are no longer necessary. |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
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 | 11 |