E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic Clear Cell Renal Cell Carcinoma |
carcinoma de células renales claras avanzado o metastásico |
|
E.1.1.1 | Medical condition in easily understood language |
Kidney Cancer |
Cancer de Riñon |
|
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 | 10050076 |
E.1.2 | Term | Metastatic renal carcinoma |
E.1.2 | System Organ Class | 100000004864 |
|
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 demonstrate PK noninferiority of SC nivolumab vs IV nivolumab administration |
Demostrar la no inferioridad en la FC de la administración s.c. de nivolumab frente a la administración i.v. de nivolumab |
|
E.2.2 | Secondary objectives of the trial |
1. To demonstrate the ORR noninferiority of SC nivolumab vs IV nivolumab administration. 2. To evaluate efficacy of SC nivolumab over 12 months. 3. To evaluate PK of SC nivolumab and IV nivolumab administration. 4. To evaluate the safety profile of SC nivolumab and IV nivolumab administration. |
1. Demostrar la no inferioridad en la FC de la administración s.c. de nivolumab frente a la administración i.v. de nivolumab 2. Evaluar la eficacia de la administración s.c de nivolumab y la administración i.v. de nivolumab 3. Evaluar la FC de la administración s.c de nivolumab y la administración i.v. de nivolumab 4. Evaluar el perfil de seguridad de la administración s.c de nivolumab y la administración i.v. de nivolumab |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Histological confirmation of renal cell carcinoma (RCC) - Advanced RCC (not amenable to curative surgery or radiation therapy) or metastatic RCC (Stage IV) - Measurable disease as defined by Response Evaluation Criteria in Solid Tumor - Received no more than 2 prior systemic treatment regimens - Progression or intolerance on or after the last treatment regimen received |
– Confirmación histológica del carcinoma de células renales (CCR) – CCR avanzado (no susceptible de cirugía curativa o radioterapia) o metastásico (estadio IV) – Enfermedad medible según los criterios de evaluación de la respuesta en tumores sólidos – Deben haber recibido no más de 2 pautas de tratamiento sistémicas previas – Deben presentar indicios de intolerancia o progresión durante o después de la última pauta posológica |
|
E.4 | Principal exclusion criteria |
- Untreated, symptomatic central nervous system (CNS) metastases. - Prior immunotherapy (medications which are target the immune system) known as PDL1 or CTLA4 or any other medications working similarly Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization - Active, known, or suspected autoimmune disease |
– Metástasis sintomáticas en el sistema nervioso central (SNC) sin tratar – Neoplasia maligna concurrente (presente durante la selección) que requiera tratamiento o antecedentes de neoplasia maligna activa previa en los 2 años anteriores a la aleatorización – Participantes con una enfermedad autoinmunitaria activa, conocida o presunta |
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Minimum of 06 months |
Mínimo de 6 meses |
|
E.5.2 | Secondary end point(s) |
1 - ORR by BICR, with a minimum of 6 months follow-up. 2 - Efficacy parameters (ORR, DCR, DOR, TTR, PFS, OS) with a minimum of 12 months follow-up. 3 - Cavgd28, Cmax1, Tmax, Cavgss, and Cminss. 4 - Incidence of AEs, SAEs, AEs leading to discontinuation, deaths, and laboratory abnormalities. |
1- TRG por RCIE, con un seguimiento mínimo de 6 meses 2- Parametros de Eficacia (ORR, DCR, DdT, THR, SSP, SG) con minimo de 12 meses de seguimiento 3- Cprom28d, Cmáx1, Tmáx, Cprom,se y Cmin,se 4- Incidencia de AA, AAG y AA que provoquen la interrupción del tratamiento y anomalías de laboratorio |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
minimum of 06 months for end points 1 and 3 above minimum of 12 months for end points 2 and 4 above |
mínimo de 06 meses para los puntos finales 1 y 3 anteriores mínimo de 12 meses para los puntos finales 2 y 4 anteriores
mínimo de 06 meses para los puntos finales 1 y 3 anteriores |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 48 |
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 |
Brazil |
Chile |
Mexico |
New Zealand |
Russian Federation |
Turkey |
United States |
Finland |
France |
Ireland |
Italy |
Poland |
Portugal |
Romania |
Spain |
Czechia |
Argentina |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
LVLS - 26-FEB-2026 |
LVLS - 26-FEB-2026 |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |