Resumen

Los principales objetivos de este estudio son aprender sobre la seguridad de sacituzumab tirumotecan con bevacizumab y si las personas lo toleran; y si las personas que toman sacituzumab tirumotecan con o sin bevacizumab viven más tiempo sin que el cáncer empeore en comparación con quienes reciben el tratamiento estándar.

Elegibilidad

Edad mínima: 18 YearsSexo: FEMALE

Criterios de inclusión

Has histologically confirmed Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies
Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)
Has platinum-sensitive epithelial OC
Has provided tissue of a tumor lesion that was not previously irradiated
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
Participants who are hepatitis B surface antigen 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 (Part 1) or randomization (Part 2)
Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)

Criterios de exclusión

Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma
Has platinum-resistant OC or platinum-refractory OC
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 (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
Has received more than 2 prior lines of systemic therapy for OC
Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)
Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids
Has an additional malignancy that is progressing or has required active treatment within the past 3 years
Has active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has an active infection requiring systemic therapy
Has active or ongoing stomatitis

Intervenciones

biological

Sacituzumab tirumotecan

IV Infusion

biological

Bevacizumab

IV Infusion

drug

H1 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

drug

H2 receptor antagonist

Rescue medication taken per approved product label before sacituzumab tirumotecan

drug

Acetaminophen (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

drug

Dexamethasone (or equivalent)

Rescue medication taken per approved product label before sacituzumab tirumotecan

drug

Steroid mouthwash (dexamethasone or equivalent)

Rescue medication taken orally 2-4 times daily

Ubicaciones

Instituto Alexander Fleming ( Site 2909)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · 5411 3221 8900

RECRUITING

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)

Mar del Plata, Buenos Aires, Argentina

Study Coordinator · +54 223 496 3224

RECRUITING

Fundación Respirar ( Site 2912)

Buenos Aires, Buenos Aires F.D., Argentina

Study Coordinator · +5491167281601

RECRUITING

Instituto de Oncologia de Rosario ( Site 2910)

Rosario, Santa Fe Province, Argentina

Study Coordinator · +543414218909

RECRUITING

Hospital Aleman ( Site 2903)

CABA, Argentina

Study Coordinator · +541148277000

RECRUITING

Hospital Italiano de Cordoba ( Site 2908)

Córdoba, Argentina

Study Coordinator · +543517078224

RECRUITING

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Sacituzumab tirumotecan

Bevacizumab

H1 receptor antagonist

H2 receptor antagonist

Acetaminophen (or equivalent)

Dexamethasone (or equivalent)

Steroid mouthwash (dexamethasone or equivalent)

Ubicaciones

Instituto Alexander Fleming ( Site 2909)

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2901)

Fundación Respirar ( Site 2912)

Instituto de Oncologia de Rosario ( Site 2910)

Hospital Aleman ( Site 2903)

Hospital Italiano de Cordoba ( Site 2908)

Patrocinadores

Contactos

Toll Free Number