Resumen

Este estudio tendrá dos fases: una fase de incorporación de seguridad con sacituzumab tirumotecan y una fase 3. La fase de incorporación de seguridad se utilizará para evaluar la eficacia y seguridad de sacituzumab tirumotecan a la dosis prevista para la fase 3. El objetivo de este estudio es comparar la eficacia y seguridad de sacituzumab tirumotecan versus el tratamiento a elección del médico como tratamiento de segunda línea en participantes con cáncer de cuello uterino recurrente o metastásico en la fase 3. Las hipótesis primarias del estudio son que, en la fase 3, sacituzumab tirumotecan resulta en una supervivencia global superior en comparación con el TPC en participantes con nivel de expresión elevado del antígeno 2 de superficie de células trofoblásticas (TROP2) y en todos los participantes.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Has histologically-confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
Must have recurrent or metastatic cervical cancer that has progressed on or after treatment with 1 prior line of systemic platinum doublet chemotherapy (with or without bevacizumab) AND must have received anti-PD-1/anti-PD-L1 therapy as part of prior cervical cancer regimens
Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, as assessed by the investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
Is assigned female sex at birth, at least 18 years of age at the time of providing the informed consent
Has ECOG performance status of 0 or 1 within 7 days before allocation for the Sacituzumab Tirumotecan Run-in or within 7 days before randomization for the Phase 3 portion
Has provided tumor tissue (most recent sample is preferred) from a core or excisional biopsy of a tumor lesion not previously irradiated
HIV-infected participants must have well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART)
Participants who are hepatitis B surface antigen (HBsAg) 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 (Sacituzumab Tirumotecan Run-in) or randomization (Phase 3 portion)
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Has adequate organ function

Criterios de exclusión

Has Grade ≥2 peripheral neuropathy
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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
Received prior systemic anticancer therapy
Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
Has other histological subtypes of cervical cancer apart from squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma (eg, carcinosarcoma), or has a diagnosis of nonepithelial cancer (eg, sarcoma, neuroendocrine tumors) of the cervix.
Known additional malignancy that is progressing or has required active treatment within the past 3 years
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Concurrent active Hepatitis B and active Hepatitis C virus infection
Severe hypersensitivity (≥Grade 3) to sacituzumab tirumotecan or treatment of physician's choice (TPC) and/or any of their excipients, or other biologic therapy
Participants who have not adequately recovered from major surgery or have ongoing surgical complications
Has a history of (noninfectious) pneumonitis/ILD that required steroids or has current pneumonitis/ILD

Ubicaciones

Hospital Británico de Buenos Aires-Oncology ( Site 0102)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +541143096400

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · 92235937663

RECRUITING

Instituto de Oncología Angel H. Roffo ( Site 0103)

Buenos Aires, Buenos Aires F.D., Argentina

Study Coordinator · 5491167281601

RECRUITING

Instituto Alexander Fleming ( Site 0108)

Buenos Aires, Buenos Aires F.D., Argentina

Study Coordinator · +54-911-3665-3009

RECRUITING

Sanatorio Allende - Cerro-Oncology ( Site 0106)

Córdoba, Córdoba Province, Argentina

Study Coordinator · 0810-555-2553

RECRUITING

Hospital Aleman-Oncology ( Site 0100)

Buenos Aires, Argentina

Study Coordinator · +541148277000

RECRUITING

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)

CABA, Argentina

Study Coordinator · +549 1152990000

RECRUITING

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)

La Rioja, Argentina

ACTIVE_NOT_RECRUITING

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Sacituzumab Tirumotecan

Pemetrexed

Tisotumab Vedotin

Topotecan

Vinorelbine

Gemcitabine

Irinotecan

Ubicaciones

Hospital Británico de Buenos Aires-Oncology ( Site 0102)

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0107)

Instituto de Oncología Angel H. Roffo ( Site 0103)

Instituto Alexander Fleming ( Site 0108)

Sanatorio Allende - Cerro-Oncology ( Site 0106)

Hospital Aleman-Oncology ( Site 0100)

Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0109)

Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0104)

Patrocinadores

Contactos

Toll Free Number