Resumen del Estudio
Este ensayo clínico de Fase 3 evalúa una terapia innovadora llamada Sacituzumab tirumotecan (MK-2870) para pacientes con cáncer de ovario, de trompas de Falopio o peritoneal primario que ha regresado (recurrente) pero que aún responde a la quimioterapia basada en platino. El objetivo principal es determinar si este medicamento, administrado solo o en combinación con bevacizumab, es seguro y capaz de frenar el avance de la enfermedad mejor que los tratamientos convencionales. El estudio está diseñado para ofrecer una alternativa terapéutica a pacientes que han recibido tratamientos previos. Se comparará el tiempo que las pacientes viven sin que el cáncer empeore (supervivencia libre de progresión) al recibir el fármaco en investigación frente a la quimioterapia estándar. Además, se permite la participación de pacientes con condiciones virales controladas (como Hepatitis B, C o VIH), ampliando el acceso a esta investigación.
Criterios de Elegibilidad
Resumen de Elegibilidad:Pueden participar mujeres con cáncer de ovario epitelial, trompa de Falopio o peritoneal primario recurrente y sensible al platino, que hayan recibido quimioterapia previa. Se permite la inclusión de pacientes con VIH, Hepatitis B o C si la carga viral es indetectable o está bien controlada. No pueden participar pacientes con cáncer resistente al platino, enfermedades oculares graves, enfermedad inflamatoria intestinal activa o problemas pulmonares (neumonitis) previos.
- Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
- Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC).
- Has platinum-sensitive epithelial OC,
- Has provided tissue of a tumor lesion that was not previously irradiated
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
- Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)
- Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
- Has an ECOG performance status of 0 to 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)
- Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma
- Has platinum-resistant OC or platinum-refractory OC
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has received more than 2 prior lines of systemic therapy for OC.
- Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)
- Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids
- Has an additional malignancy that is progressing or has required active treatment within the past 3 years
- Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has an active infection requiring systemic therapy