Resumen del Estudio
Este estudio clínico de fase 3 busca mejorar las opciones de tratamiento para mujeres con cáncer de endometrio avanzado o recurrente que presentan una característica molecular específica llamada 'reparación de desajustes competente' (pMMR). Esta condición significa que las células tumorales conservan ciertos mecanismos de reparación del ADN, lo que a veces las hace menos sensibles a la inmunoterapia estándar por sí sola. Los investigadores están evaluando si la combinación de dos medicamentos potentes ofrece mejores resultados que el uso de uno solo tras una quimioterapia inicial. Se probará el 'Sacituzumab Tirumotecan' (un conjugado anticuerpo-fármaco que entrega quimioterapia directamente a las células tumorales) junto con 'Pembrolizumab' (una inmunoterapia que ayuda al sistema inmune a detectar el cáncer), comparándolo con el uso de Pembrolizumab solo. El objetivo principal es determinar si la combinación ayuda a las pacientes a vivir más tiempo sin que la enfermedad progrese.
Criterios de Elegibilidad
Resumen de Elegibilidad:Criterios de inclusión: Mujeres con diagnóstico confirmado de carcinoma de endometrio avanzado o recurrente tipo pMMR (reparación competente). Deben tener enfermedad medible radiológicamente y no ser candidatas a cirugía curativa. Criterios de exclusión: Pacientes con tumores tipo dMMR (deficientes), carcinosarcomas o sarcomas. Historial de enfermedad inflamatoria intestinal activa, enfermedades autoinmunes graves o problemas cardiovasculares no controlados. No deben haber recibido tratamientos previos con inmunoterapia (anti-PD-1/L1) o conjugados dirigidos a TROP2.
- Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)
- Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator.
- Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if \>2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment
- Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas
- Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)
- Is a candidate for curative-intent surgery or curative-intent radiotherapy at the time of enrollment
- Has a 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
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
- Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate