Resumen

Los investigadores buscan nuevas formas de tratar a personas con cáncer de endometrio (CE) con reparación de errores de emparejamiento competente (pMMR) que sea avanzado o recurrente. * El CE es un tipo de cáncer que se origina en los tejidos del interior del útero (matriz). * pMMR indica que ciertas proteínas normales están presentes en las células cancerosas. * Avanzado significa que el cáncer se ha diseminado localmente o a otras partes del cuerpo (metastásico) y no puede extirparse mediante cirugía. * Recurrente significa que el cáncer reapareció después de la cirugía. Sacituzumab tirumotecan (también conocido como Sac-TMT) y pembrolizumab son los medicamentos del estudio. Sac-TMT es un conjugado de anticuerpo y fármaco (ADC). Un ADC se une a dianas específicas en las células cancerosas y administra el tratamiento para destruirlas. El objetivo de este estudio es determinar si las personas que reciben Sac-TMT con pembrolizumab viven más tiempo y sin que el cáncer empeore en comparación con las personas que reciben pembrolizumab solo.

Descripción detallada

Todos los participantes pasan por una fase de inducción inicial de seis ciclos, cada uno de los cuales consiste en pembrolizumab + carboplatino + paclitaxel o docetaxel. Cada ciclo dura tres semanas. Los participantes cuyo cáncer no progrese ingresan a la fase de tratamiento de mantenimiento y se les asigna aleatoriamente pembrolizumab + Sac-TMT o pembrolizumab en monoterapia. Los participantes cuyo cáncer progrese tendrán la posibilidad de ingresar a la fase de tratamiento posterior y se les asignará aleatoriamente pembrolizumab + Sac-TMT o Sac-TMT en monoterapia.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

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

Criterios de exclusión

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 debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following 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

Intervenciones

biological

Pembrolizumab

Intravenous (IV) Infusion

drug

Carboplatin

During the Induction Phase, participants receive carboplatin AUC 5 (mg/mL/min) on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.

drug

Paclitaxel

During the Induction Phase, participants receive paclitaxel 175 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.

drug

Docetaxel

During the Induction Phase, participants may receive docetaxel (in place of paclitaxel) 75 mg/m\^2 on Day 1 of each 3-week cycle for 6 cycles (up to approximately 4 months) via IV infusion.

biological

Sacituzumab Tirumotecan

IV Infusion

Ubicaciones

Instituto Alexander Fleming ( Site 0105)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +5491166936669

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0108)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +542234963223

RECRUITING

Fundación Respirar ( Site 0101)

Buenos Aires, Buenos Aires F.D., Argentina

Study Coordinator · +541147815331

RECRUITING

Hospital Británico de Buenos Aires ( Site 0103)

CABA, Argentina

Study Coordinator · +541143096400

RECRUITING

Instituto San Marcos ( Site 0106)

San Juan, Argentina

Study Coordinator · +542645836798

RECRUITING

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Pembrolizumab

Carboplatin

Paclitaxel

Docetaxel

Sacituzumab Tirumotecan

Ubicaciones

Instituto Alexander Fleming ( Site 0105)

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0108)

Fundación Respirar ( Site 0101)

Hospital Británico de Buenos Aires ( Site 0103)

Instituto San Marcos ( Site 0106)

Patrocinadores

Contactos

Toll Free Number