E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage III A/B/C/D, Stage IV melanoma or Muscle-Invasive Urothelial Carcinoma |
Melanoma resecado estadio IIIA/B/C/D o IV o con carcinoma urotelial (CU) invasivo resecado |
|
E.1.1.1 | Medical condition in easily understood language |
Melanoma and Bladder Cancer |
Melanoma y carcinoma en la vejiga |
|
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 participants' preference upon switching from Nivo IV to Nivo SC |
Evaluar la preferencia de los participantes al cambiar de Nivo i.v. a Nivo s.c. |
|
E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of Nivo SC and Nivo IV To evaluate participants' preference for Nivo SC after the switch period |
Evaluar la seguridad y la tolerabilidad de Nivo s.c. y Nivo i.v. Evaluar la preferencia de los participantes por Nivo s.c. después del período de cambio |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Eligible for adjuvant therapy for melanoma or muscle-invasive urothelial carcinoma originating from the bladder • Melanoma: resected Stage IIIA/B/C/D or Stage IV (AJCC 8th edition) • Bladder: pT3-pT4a or pN+ ineligible or refusal of adjuvant cisplatin chemotherapy OR ypT2-pT4a or ypN+ who received neo-adjuvant cisplatin chemotherapy - ECOG performance status 0-1; ≥18 |
bLos participantes deben ser aptos para recibir tratamiento adyuvante por un melanoma o CU con invasión muscular originado en la vejiga. - Melanoma :resección en estadio IIIA/B/C/D o Stado IV (AJCC, 8ª edición) -Vegiga: que no hayan recibido quimioterapia neoadyuvante con cisplatino: pT3-pT4a o pN+ o que hayan recibido quimioterapia neoadyuvante con cisplatino: ypT2-pT4a o ypN+. -ECOG de 0 o 1; Mayor o igual a 18. |
|
E.4 | Principal exclusion criteria |
• Ocular or mucosal melanoma • Upper tract urothelial carcinoma (ureter, renal pelvis), NMIBC • Untreated/unresected CNS or leptomeningeal metastases • Prior treatment with immuno-oncology agents |
- melanoma ocular o de mucosas - CU de vías urinarias superiores (uréter, pelvis renal), NMIBC - Metástasis en el SNC o leptomeníngeas no tratadas o no resecadas - No se permite el tratamiento previo con agentes inmuno-oncologicos |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants that prefer Nivo SC at the first assessment of patient preference using PEPQ (Question 1) |
• Proporción de participantes que prefieran el uso de Nivo s.c. en la primera evaluación del paciente mediante el cuestionario PEPQ (pregunta 1) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
After the first assessment of patient experience and preference questionnaire |
Cuestionario sobre la experiencia y preferencias del después de la primera evaluacion |
|
E.5.2 | Secondary end point(s) |
-Incidence of all AEs, SAEs, treatment-related AEs including IMAEs, AEs & SAEs leading to discontinuation or death -Proportion of participants that prefer Nivo SC at the second patient preference assessment using PEPQ (Question 1) |
• Incidencia de todos los AA, AAG, AA relacionados con el tratamiento, incluidos los AAI, AA y AAG que motiven la suspensión del tratamiento o la muerte • Proporción de participantes que prefieran el uso de Nivo s.c. en la segunda evaluación de preferencias del paciente mediante el cuestionario PEPQ (pregunta 1) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Throughout the treatment period, lasting from start of Nivo IV until 100 days following discontinuation of Nivo dosing - After the second assessment of the patient experience and preference questionnaire |
- A traves del periodo de tratamiento, durante un mínimo de 100 días después de suspender la administración. de Nivo - Cuestionario sobre la experiencia y preferencias del después de la segunda evaluación |
|
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
To evaluate participants' preference for Nivo SC after the switch period |
• Evaluar la preferencia de los participantes por Nivo s.c. después del período de cambio |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 |
United States |
Spain |
Germany |
Italy |
|
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
|
End of trial is defined as the last participant last visit or completion of Survival Follow-up Visit. Study completion is defined as the final date on which last participant has completed the end of trial visit (last visit or Survival Follow-up Visit). |
- Fin del Ensayo esta definido como ultima visita ultimo paciente o completada la Visita de Seguimiento de Supervivencia. - Completar el estudio se define como la fecha final sobre la cual el ultimo participante ha completado la visita de fin de estudio (ultima visita o completada la Visita de Seguimiento de Supervivencia). |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 23 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 23 |