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) |
Este protocolo maestro para los subestudios de continuación de avelumab se ha diseñado para adaptarse al acceso continuado a la intervención del estudio, el seguimiento de seguridad y, cuando corresponda, el seguimiento de la supervivencia en general para los participantes elegibles que reciban la intervención del estudio y que sigan recibiendo beneficios del tratamiento o que estén en seguimiento en un estudio de avelumab patrocinado por Pfizer (estudio original), que se debe cerrar. |
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E.1.1.1 | Medical condition in easily understood language |
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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 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 B9991005), Amendment 1dd. 07 Jul 2021: AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE B9991005 AVELUMAB STUDY Objectives: To monitor the safety and tolerability of avelumab and lorlatinib - Protocol B9991046 (Parent Study B9991009), Amendment 1dd. 07 Jul 2021: AN OPEN-LABEL STUDY FOR CONTINUED TREATMENT ACCESS FOR PARTICIPANTS FROM THE B9991009 AVELUMAB STUDY Objectives: To monitor the safety and tolerability of avelumab |
En este protocolo maestro para los subestudios de continuación de avelumab, se incluirá un máximo de 9 subestudios y 300 participantes. - Protocolo B9991046 (estudio original B9991005), Modificación 1 del protocolo del subestudio de continuación final, 07 de julio de 2021: ESTUDIO ABIERTO PARA EL ACCESO CONTINUO AL TRATAMIENTO DE LOS PARTICIPANTES DEL ESTUDIO DE AVELUMAB B9991005 Objetivos: Supervisar la seguridad y tolerabilidad de avelumab y lorlatinib
- Protocolo B9991046 (estudio original B9991009), Modificación 1 del protocolo del subestudio de continuación final, 07 de julio de 2021: ESTUDIO ABIERTO PARA EL ACCESO CONTINUO AL TRATAMIENTO DE LOS PARTICIPANTES DEL ESTUDIO B9991009 AVELUMAB Objetivos: realizar un seguimiento de la seguridad y tolerabilidad del Avelumab |
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E.2.2 | Secondary objectives of the trial |
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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. |
1. Cualquier participante que reciba el tratamiento del estudio y beneficios clínicos significativos (según lo determine el investigador principal) o que se encuentre en el periodo de seguimiento de seguridad o supervivencia en un estudio original de avelumab patrocinado por Pfizer. 2. Los participantes deben aceptar seguir los criterios reproductivos descritos en el Apéndice 4 (Sección 10.4.1 para hombres y Sección 10.4.2 para mujeres) del protocolo del subestudio de continuación de avelumab aplicable. 3. Participantes que estén dispuestos y sean capaces de cumplir con todas las visitas programadas, el plan de tratamiento y otros procedimientos del estudio, según lo descrito en el protocolo del subestudio de continuación de avelumab. 4. Capacidad de dar el consentimiento informado firmado, tal como se describe en el Apéndice 1, Sección 10.1.3, que incluye el cumplimiento de los requisitos y las restricciones que figuran en el DCI y en este protocolo. |
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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. |
Los participantes se excluyen del estudio si se aplica alguno de los siguientes criterios: 1. Participantes de sexo femenino embarazadas o en periodo de lactancia. 2. Cualquier razón médica que, a criterio del investigador o patrocinador, impida la inclusión del participante en el estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
AEs leading to permanent discontinuation of study interventiona All SAEs |
• AA que conducen a la interrupción permanente de la intervención del estudio • Todos los AAG |
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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) |
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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 | 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) | 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 | 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 | 4 |
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 |
Australia |
Russian Federation |
Belgium |
France |
Spain |
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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. |
Se define que el final de este protocolo maestro es cuando el último participante del último subestudio de continuación de avelumab se retira del estudio o 5 años después del inicio del estudio (lo que ocurra primero). Sin embargo, el patrocinador puede finalizar en cualquier momento el protocolo maestro para los subestudios de continuación de avelumab o los estudios de continuación. |
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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 |