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olvimulogene nanivacirepvec
Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)
Ensayo de GENELUX Corp en Platinum-resistant Ovarian Cancer · Platinum-refractory Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Cancer · High-grade Serous Ovarian Cancer · Endometrioid Ovarian Cancer · Ovarian Clear Cell Carcinoma (del registro, en inglés).
Más ensayos de: Cáncer de ovario resistente al platino · Cáncer de trompa de Falopio · Carcinoma peritoneal primario.
- Fase
- Fase 3
- Estado
- Reclutando pacientes
- Participantes
- 186
- Centros
- 33
- Fin del objetivo primario
- dic 2026
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en ago 2022.
Qué mide
Progression-free survival (PFS) by RECIST 1.1 in the Intention-to-Treat (ITT) population (all randomized participants regardless of whether they received any dose of treatment) (From date of randomization up to 12 months) (del registro, en inglés)
Qué se prueba
Se compara Olvi-Vec seguido de quimioterapia con platino y bevacizumab frente al tratamiento elegido por el medico en mujeres con cancer de ovario resistente o refractario al platino.
Lo que dice el documentoevaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer).
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.
Más ensayos de GNLX
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| Olvimulogene nanivacirepvec · VIRO-25 | Fase 2 | Reclutando pacientes | feb 2027 (prevista) |
| Olvi-Vec | Fase 1/2 | Completado | dic 2021 (real) |
| GL-ONC1 | Fase 1 | Completado | nov 2015 (real) |
| GL-ONC1 | Fase 1 | Completado | jun 2015 (real) |
| GL-ONC1 | Fase 1/2 | Completado | sep 2014 (real) |
| GL-ONC1 | no aplica | Ya no disponible | sin fecha |
Todos los de GNLX, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT05281471), actualizada en ago 2026.