E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced Tumors |
Tumores avanzados |
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E.1.1.1 | Medical condition in easily understood language |
Advanced Tumors/Cancer |
Tumores avanzados / Cancer |
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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 | LLT |
E.1.2 | Classification code | 10048683 |
E.1.2 | Term | Advanced cancer |
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 estimate the OS. |
Determinar la supervivencia global (SG) |
|
E.2.2 | Secondary objectives of the trial |
- To estimate the DOR and DOCR per evaluation criteria used in the parent trial by investigator assessment for participants who have received or are receiving First Course Phase trial treatment with pembrolizumab or a pembrolizumab based combination. - To evaluate the safety and tolerability of pembrolizumab or a pembrolizumab-based combination in participants who receive it as First or Second Course Phase trial treatment. |
-Determinar la duración de la respuesta (DR) y la duración de la respuesta completa (DRC) conforme a los criterios de evaluación utilizados en el ensayo original, según la evaluación del investigador, en participantes que hayan recibido o estén recibiendo el tratamiento del ensayo con pembrolizumab o una combinación basada en pembrolizumab en la primera fase de tratamiento -Evaluar la seguridad y la tolerabilidad de pembrolizumab o una combinación basada en pembrolizumab en participantes que lo reciban como tratamiento del ensayo en la primera o segunda fase de tratamiento |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Merck will also analyse microbiome from stool. The broad objective of the stool microbiome sub-study is to explore new biomarkers predictive of pembrolizumab response. |
Merck también analizará el microbioma de muestras de heces. El objetivo ampliado del sub-estudio de microbioma en heces es explorar nuevos biomarcadores predictivos de la respuesta de pembrolizumab |
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E.3 | Principal inclusion criteria |
1. Participants that are currently enrolled in MSD-sponsored pembrolizumab trials and are receiving trial treatment or in a Follow-up Phase at the time KN587 is open. The parent trials must have completed all regulatory requirements and submissions, if any, or have fully addressed their primary endpoint(s) before all their participants roll over into KN587. 2. The participant (or legally acceptable representative if applicable) provides informed consent for the trial and agrees to follow study procedures. |
1-Participantes que estén participando actualmente en ensayos de pembrolizumab patrocinados por MSD y estén recibiendo el tratamiento del ensayo o se encuentren en una fase de seguimiento en el momento en que se abra el estudio KN587. Los ensayos originales deberán haber completado todos los requisitos y solicitudes administrativas, en su caso, o haber abordado sus criterios de valoración principales antes de que todos los participantes continúen en el estudio KN587. 2-El participante (o su representante legal cuando proceda) otorga su consentimiento informado por escrito para el ensayo y se compromete a seguir los procedimientos del estudio. |
|
E.4 | Principal exclusion criteria |
There are no exclusion criteria to participate in KN587. |
No hay criterios de exclusión para participar en el estudio KN587 |
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E.5 End points |
E.5.1 | Primary end point(s) |
OS is defined as the time from randomization or start of trial treatment for non-randomized participants (on the parent study) to death due to any cause. Participants without documented death at the time of analysis will be censored at the date of the last follow-up. |
La supervivencia global se define como el periodo desde la randomización o el inicio del tratamiento del estudio para los pacientes no randomizados (en el estudio inicial) hasta el fallecimiento por cualquier causa. Los participantes cuya muerte no se haya documentado en el momento del análisis de los datos serán censurados a fecha del último seguimiento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
No planned interim analyses will be performed. Periodic summaries of study results will be produced. Subjects will be followed until death. |
No se planean análisis intermedios. Se crearán resúmenes de los resultados del estudio periódicamente. Se hará seguimiento de los pacientes hasta su fallecimiento. |
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E.5.2 | Secondary end point(s) |
- DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response on the parent trial until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment. - DOCR is determined by disease assessment and is defined as the time from the date of CR on the parent trial until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment. - Participants who experience SAEs, AEOSI or ECI. |
-La duración de la respuesta se determina mediante la evaluación de la enfermedad y se define como el tiempo que transcurre entre la fecha más temprana de respuesta cualificada en el ensayo original hasta la fecha más temprana de progresión de la enfermedad o muerte por cualquier causa, lo que ocurra primero, basándose en la evaluación del investigador. -La duración de la respuesta completa se determina mediante la evaluación de la enfermedad y se define como el periodo desde la fecha de respuesta completa del ensayo original hasta la fecha más temprana de progresión de la enfermedad, o muerte por cualquier causa, lo que ocurra primero, basándose en la evaluación del investigador. -Participantes que experiencien SAEs, AEOSI o ECI - (vamos a dejar las siglas en inglés) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
No planned interim analyses will be performed. Periodic summaries of study results will be produced. Subjects will be followed until death. |
No se planean análisis intermedios. Se crearán resúmenes de los resultados del estudio periódicamente. Se hará seguimiento de los pacientes hasta su fallecimiento. |
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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 | 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 | Yes |
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 | 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 | 3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | No |
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 |
Austria |
Belgium |
Canada |
Chile |
Colombia |
France |
Germany |
Israel |
Italy |
Korea, Republic of |
Netherlands |
New Zealand |
Norway |
Spain |
Sweden |
Switzerland |
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
|
The overall study ends when the last participant completes the last study-related phone-call or visit, withdraws from the study or is lost to follow-up (ie, the participant is unable to be contacted by the investigator). |
El estudio en su conjunto finalizará cuando el último participante complete la última llamada telefónica o visita del estudio, se retire del estudio o se pierda para el seguimiento (es decir, cuando el investigador no pueda ponerse en contacto con el participante). |
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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 | 9 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 23 |
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 |