Estudio aleatorizado, abierto, de fase 3, de sacituzumab govitecan y pembrolizumab versus tratamiento a elección del médico y pembrolizumab en pacientes con cáncer de mama triple negativo localmente avanzado no operable o metastásico no tratado previamente, cuyos tumores expresan PD-L1

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05382286Tipo: INTERVENTIONALInicio: 25 de jul de 2022Fin estimado: 1 de feb de 2027

Resumen

El objetivo primario de este estudio es comparar la supervivencia libre de progresión (SLP) entre sacituzumab govitecan-hziy (SG) y pembrolizumab versus el tratamiento a elección del médico (TEM) y pembrolizumab en participantes con cáncer de mama triple negativo (CMTN) localmente avanzado no operable o metastásico no tratado previamente, cuyos tumores expresan el ligando de muerte celular programada 1 (PD-L1).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (TNBC) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (PD-L1) positive at screening.
Individuals must have completed treatment for Stage I to III breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence.
Individuals presenting with de novo metastatic TNBC are eligible for this study.
TNBC status and tumor PD-L1 combined positive score (CPS) will be confirmed centrally on a recent or archival tumor specimen.
Individuals must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria as evaluated locally.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Demonstrates adequate organ function
Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease.

Criterios de exclusión

Positive serum pregnancy test or women who are lactating.
Received prior therapy with an agent directed to another stimulatory or coinhibitory T-cell receptor.
Individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment.
Individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. Individuals participating in observational studies are eligible.
Have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor.
Have an active second malignancy.
Have active serious infection requiring antibiotics.
Individuals positive for HIV-1 or 2 with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Has an active autoimmune disease that has required systemic treatment in the past 2 years.

Intervenciones

drug

Sacituzumab Govitecan-hziy

Administered intravenously

drug

Pembrolizumab

Administered intravenously

drug

Paclitaxel

Administered intravenously

drug

nab-Paclitaxel

Administered intravenously

drug

Gemcitabine

Administered intravenously

drug

Carboplatin

Administered intravenously

Ubicaciones

Hospital Británico de Buenos Aires

Buenos Aires, Argentina

Instituto de Oncología Ángel H. Roffo

CABA, Argentina

Fundacion CORI para la Investigacioy y Prevención del Cancer

Capital, Argentina

Instituto de Oncologia de Rosario

Rosario, Argentina

CAIPO Centro Para La Atención Integral Del Pacient

San Miguel de Tucumán, Argentina

Clinica Viedma

Viedma, Argentina

Patrocinadores

PrincipalGilead Sciences

ColaboradorMerck Sharp & Dohme LLC

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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