E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This Master Protocol for Avelumab Continuation Sub-Studies has been designed to accommodate continued access to study intervention, safety follow-up, and when applicable, overall survival follow up, for eligible participants receiving study intervention and who continue to derive treatment benefit or who are in follow-up in a Pfizer-sponsored avelumab study (Parent Study) |
Questo protocollo principale per i sottostudi di continuazione di Avelumab è stato progettato per consentire l'accesso continuo all'intervento dello studio, al follow-up di sicurezza e, se applicabile, al follow-up della sopravvivenza globale, per i partecipanti idonei che ricevono l'intervento dello studio e che continuano a trarre beneficio dal trattamento o che sono nel follow-up di uno studio su avelumab sponsorizzato da Pfizer (studio dei genitori) |
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E.1.1.1 | Medical condition in easily understood language |
Not applicable |
Non applicabile |
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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 | PT |
E.1.2 | Classification code | 10058467 |
E.1.2 | Term | Lung neoplasm malignant |
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 monitor the safety and tolerability of study intervention(s) A maximum of 9 sub studies and a maximum of 300 participants will be included in this Master Protocol for Avelumab Continuation Sub-Studies. - Protocol B9991046 (Parent Study B9991032), Amendment 24 Jun 2021: AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE B9991032 AVELUMAB STUDY Objectives: To monitor the safety and tolerability of avelumab and talazoparib - Protocol B9991046 (Parent Study B9991023), Amendment 23 Jul 2021: AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE B9991023 AVELUMAB STUDY Objectives: To monitor the safety and tolerability of avelumab and chemotherapy (pemetrexed) - Protocol B9991046 (Parent Study B9991025), Amendment 24 Jun 2021: AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE B9991025 AVELUMAB STUDY |
Monitorare la sicurezza e la tollerabilità del/i prodotto/i oggetto di studio Nel presente studio master per i sottostudi di prosecuzione con avelumab saranno inclusi al massimo 9 sottostudi e al massimo 300 partecipanti. - Protocollo B9991046 (Parent Study B9991032), emendamento 24 giugno 2021: UNO STUDIO APERTO PER L'ACCESSO CONTINUO AL TRATTAMENTO PER I PARTECIPANTI DALLO STUDIO B9991032 AVELUMAB Obiettivi: monitorare la sicurezza e la tollerabilità di avelumab e talazoparib - Protocollo B9991046 (Parent Study B9991023), emendamento 23 luglio 2021: UNO STUDIO APERTO PER L'ACCESSO CONTINUO AL TRATTAMENTO PER I PARTECIPANTI DALLO STUDIO B9991023 AVELUMAB Obiettivi: monitorare la sicurezza e la tollerabilità di avelumab e chemioterapia (pemetrexed) - Protocollo B9991046 (Parent Study B9991025), Emendamento 24 Jun 2021: UNO STUDIO IN APERTO PER L'ACCESSO CONTINUO AL TRATTAMENTO PER I PARTECIPANTI DALLO STUDIO B9991025 AVELUMAB |
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E.2.2 | Secondary objectives of the trial |
Not applicable |
Non applicabile |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants are eligible to be included in the study only if all the following criteria apply: 1.Any participant who is receiving study treatment and deriving significant clinical benefit (as determined by the Principal Investigator) or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study. 2.Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Avelumab Continuation Sub-Study Protocol. 3.Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the appliable Avelumab Continuation Sub-Study Protocol. 4.Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. |
I partecipanti sono idonei all’inclusione nello studio solo se soddisfano tutti i criteri seguenti: 1. Qualsiasi partecipante che stia assumendo il trattamento in studio e ne tragga un beneficio clinico significativo (come determinato dallo Sperimentatore principale) o che si trovi nel periodo di follow-up di sicurezza e/o sopravvivenza in uno Studio principale su avelumab sponsorizzato da Pfizer. 2. I partecipanti devono accettare di rispettare i criteri relativi alla riproduzione come indicato nell’Appendice 4 (paragrafo 10.4.1 per i soggetti di sesso maschile e paragrafo 10.4.2 per i soggetti di sesso femminile) del Protocollo dello studio secondario di prosecuzione con avelumab applicabile. 3. Partecipanti disposti e in grado di rispettare tutte le visite programmate, il piano di trattamento e le altre procedure di studio come indicato nel Protocollo dello studio secondario di prosecuzione con avelumab applicabile. 4. In grado di fornire il consenso informato firmato come descritto nell’Appendice 1, paragrafo 10.1.3, che comprende la conformità ai requisiti e alle restrizioni riportati nell’ICD e nel presente protocollo. |
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E.4 | Principal exclusion criteria |
Participants are excluded from the study if any of the following criteria apply: 1.Female participants who are pregnant or breastfeeding. 2.Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study. |
I partecipanti vengono esclusi dallo studio se rispondono a uno dei seguenti criteri: 1. Partecipanti di sesso femminile gestanti o in allattamento. 2. Qualsiasi ragione di natura medica che, a giudizio dello Sperimentatore o dello Sponsor, impedisca al partecipante di partecipare allo studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
- AEs leading to permanent discontinuation of study interventions - All SAEs |
- Eventi avversi con conseguente interruzione definitiva del farmaco oggetto di studio - Tutti i SAE |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Non applicabile |
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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 | Yes |
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 | 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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
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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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
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 |
Belgium |
Canada |
Hungary |
Italy |
Korea, Republic of |
Russian Federation |
Spain |
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 Master Protocol is defined as when the last participant in the last Avelumab Continuation Sub-Study has come off study, or 5 years after study initiation (whichever is sooner). However, the Sponsor may terminate the Master Protocol for Avelumab Continuation Sub-Studies or Continuation Study/ies at any time. |
La fine di questo Protocollo Master è definita come quando l'ultimo partecipante all'ultimo Avelumab Continuation Sub-Study è uscito dallo studio, o 5 anni dopo l'inizio dello studio (a seconda dell'evento che avviene prima). Tuttavia, lo sponsor può terminare il protocollo principale per gli studi secondari di continuazione di Avelumab o gli studi di continuazione in qualsiasi momento. |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |