E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Solid Tumors |
Tumori solidi |
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E.1.1.1 | Medical condition in easily understood language |
Solid Tumors |
Tumori solidi |
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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 | 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 | 100000004864 |
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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 monitor the safety and tolerability of avelumab in participants with solid tumors who continue treatment with avelumab under the same treatment regimen as in the parent avelumab study |
Monitorare la sicurezza e la tollerabilità di avelumab nei partecipanti con tumori solidi che continuano il trattamento con avelumab allo stesso regime terapeutico che seguivano nello studio originario su avelumab |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the overall survival (OS) (for NSCLC, RCC, UC, and ovarian cancer indications only)
- To evaluate the progression free survival (PFS)
- To evaluate duration of response (DR) |
Valutare la sopravvivenza globale (OS) (solo per le indicazioni di carcinoma polmonare non a piccole cellule [NSCLC], carcinoma a cellule renali [RCC], carcinoma uroteliale [CU] e tumore dell’ovaio)
Valutare la sopravvivenza libera da progressione (PFS)
Valutare la durata della risposta (DR)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participants under enrollment and treatment in an avelumab clinical study under the sponsorship of Merck KGaA
- Participants currently enrolled in an avelumab parent study and are on active treatment with avelumab or in long-term survival follow-up after treatment
- Participants on active treatment must agree to continue to use highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female participants if the risk of conception exists |
- Partecipanti arruolati e trattati in uno studio clinico su avelumab sponsorizzato da Merck KGaA
- Partecipanti attualmente arruolati in uno studio originario con avelumab e che sono in fase di trattamento attivo con avelumab o di follow-up di sopravvivenza a lungo termine dopo il trattamento
- I partecipanti di sesso maschile e femminile che ricevono un trattamento attivo devono acconsentire a continuare a utilizzare un metodo contraccettivo altamente efficace (ovvero, metodi con un tasso di fallimento inferiore all’1% annuo), qualora esista il rischio di concepimento
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E.4 | Principal exclusion criteria |
- Participants who are pregnant or breastfeeding
- Participants still on active treatment: Known hypersensitivity to any of the study intervention ingredients
- Participant has been enrolled in the comparator arm of avelumab parent study
- Participant has been withdrawn from avelumab parent study for any reason
- Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study |
- Partecipanti in gravidanza o in allattamento
- Partecipanti ancora in fase di trattamento attivo: Ipersensibilità nota a uno qualsiasi dei componenti dell’intervento dello studio
- Partecipante arruolato nel braccio di confronto con avelumab dello studio originario
- Partecipante ritirato dallo studio originario con avelumab per un qualsiasi motivo
- Qualsiasi altro motivo che, a giudizio dello Sperimentatore, precluda il partecipante dalla partecipazione allo studio
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of treatment-related non-serious treatment-emergent adverse events (TEAEs), all serious adverse events (SAEs), immune-related adverse events (irAEs), and infusion-related reactions according to the version of National Cancer Institute Common Technology Criteria for Adverse Events (NCI-CTCAE) used in the respective parent study |
Insorgenza di eventi avversi emergenti dal trattamento (TEAE) non seri correlati al trattamento, tutti gli eventi avversi seri (SAE), gli eventi avversi immunocorrelati (irAE) e le reazioni correlate all’infusione, in base alla versione dei Criteri comuni di terminologia per gli eventi avversi dell’Istituto nazionale dei tumori (NCI CTCAE) utilizzata nel relativo studio originario |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
From enrolment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab). |
Dall’arruolamento alla fine del follow-up di sopravvivenza (fino a un massimo di 5 anni dopo che l’ultimo partecipante riceve l’ultima dose di avelumab). |
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E.5.2 | Secondary end point(s) |
1 Number of Participants with Overall Survival (OS)
2 Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
3 Duration of Response (DR) Assessed from Complete Response (CR) or Partial Response (PR) |
1 Numero di partecipanti con sopravvivenza complessiva (OS)
2 Sopravvivenza libera da progressione (PFS) in base ai criteri di valutazione
della risposta nei tumori solidi versione 1.1 (RECIST v1.1)
3 Durata della risposta (DR) valutata dalla risposta completa (CR) o dalla risposta parziale (PR)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 From baseline (parent study) up to 5 years
2 From baseline (parent study) up to 5 years
3 From baseline (parent study) up to 5 years |
1 Dal basale (studio originario) fino a 5 anni
2 Dal basale (studio originario) fino a 5 anni
3 Dal basale (studio originario) fino a 5 anni
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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 | 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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 |
Brazil |
Chile |
Colombia |
Japan |
Korea, Republic of |
Mexico |
Peru |
Russian Federation |
South Africa |
Taiwan |
Turkey |
United States |
Belgium |
Bulgaria |
Denmark |
France |
Germany |
Hungary |
Italy |
Poland |
Romania |
Spain |
United Kingdom |
Czechia |
Argentina |
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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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End of the post-treatment follow-up period, defined in the clinical study protocol as being part of the study.
If the study is not terminated for a reason given in Protocol Section 7.1, the survival follow-up will continue until up to a maximum of 5 years after the last participant receives the last dose of avelumab. This duration may be shortened at the discretion of the Sponsor for any given indication. |
Fine del periodo di follow-up post-trattamento, definito nel protocollo dello studio clinico come parte dello studio.
Se lo studio non viene interrotto per un motivo indicato nella Sezione 7.1 del Protocollo, il follow-up di sopravvivenza continuerà fino a un massimo di 5 anni dopo che l’ultimo partecipante avrà ricevuto l’ultima dose di avelumab. Questo periodo può subire una riduzione per qualsiasi indicazione a discrezione dello sponsor.
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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 | 5 |
E.8.9.1 | In the Member State concerned days | 12 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
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 | 15 |