Estudio de fase 3, aleatorizado, controlado activo, abierto y multicéntrico para comparar la eficacia y la seguridad de la monoterapia con MK-2870 frente al tratamiento a elección del médico en participantes con cáncer de endometrio que han recibido quimioterapia basada en platino e inmunoterapia previas (MK-2870-005/ENGOT-en23/GOG-3095)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06132958Tipo: INTERVENTIONALInicio: 6 de dic de 2023Fin estimado: 10 de ene de 2028

Resumen

Los investigadores buscan nuevas formas de tratar a personas con cáncer de endometrio (CE) que hayan recibido previamente tratamiento con terapia basada en platino (un tipo de quimioterapia) e inmunoterapia. La inmunoterapia es un tratamiento que ayuda al sistema inmunológico a combatir el cáncer. Este estudio clínico comparará sacituzumab tirumotecan con quimioterapia. El objetivo del estudio es conocer si las personas que reciben sacituzumab tirumotecan viven más tiempo en general y sin que el cáncer empeore en comparación con las personas que reciben quimioterapia.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Has a histologically-confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
Has radiographically evaluable disease, either measurable or nonmeasurable per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR).
Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.

Criterios de exclusión

Has neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas
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 had a recurrence of endometrial carcinoma or carcinosarcoma more than \>12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting. Note: 1) If Immunotherapy-based treatment is administered in the recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from time of adjuvant therapy 2) For Stage IVb disease, treatment that includes gynecological surgery followed by a platinum-based regimen is NOT considered curative-intent per protocol and does not require platinum rechallenge in the recurrent setting, regardless of the duration of the platinum-free interval
Has received more than 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma
Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Has received prior treatment with single-agent nonplatinum based chemotherapy in the third-line setting
Has received prior treatment with a trophoblast cell surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC) (eg, sacituzumab govitecan)
Has received prior treatment with a topoisomerase I inhibitor-containing ADC (eg, sacituzumab govitecan or fam-trastuzumab deruxtecan-nxki)
Has previously received both single-agent paclitaxel and single-agent doxorubicin in any setting for prior treatment of endometrial cancer
Requires recurrent drainage of effusions (e.g., pleural, ascitic, etc.) within 6 weeks before randomization

Intervenciones

biological

Sacituzumab tirumotecan

4 mg/kg of sacituzumab tirumotecan by IV infusion

drug

Doxorubicin

60 mg/m\^2 of doxorubicin by IV Infusion

drug

Paclitaxel

80 mg/m\^2 of paclitaxel by IV infusion

drug

Nab-paclitaxel

100 mg/m\^2 of nab-paclitaxel by IV infusion

Ubicaciones

Hospital Británico de Buenos Aires-Oncology ( Site 1002)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008)

Buenos Aires, Buenos Aires F.D., Argentina

Instituto Alexander Fleming-Alexander Fleming ( Site 1007)

Buenos Aires, Buenos Aires F.D., Argentina

Hospital Aleman-Oncology ( Site 1001)

Buenos Aires, Argentina

Instituto de Oncología Angel H. Roffo ( Site 1003)

Buenos Aires, Argentina

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1004)

Buenos Aires, Argentina

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006)

La Rioja, Argentina

Patrocinadores

PrincipalMerck Sharp & Dohme LLC

ColaboradorEuropean Network for Gynaecological Oncological Trial groups(ENGOT)

ColaboradorGOG Foundation

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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