Last updated 45 hours ago
Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer
600 patients around the world
Available in Brazil, United States
AstraZeneca
600Patients around the world
This study is for people with
Ovarian cancer
Fallopian tube cancer
Peritoneal cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer.Provision of an archival FFPE tumour sample.Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy.Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment.Participants who received at least 6 cycles of PBC during the induction phase of their current line of treatment.Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation.Participants with non-progressive disease upon completion of PBC in their current line of treatment.Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance).
- Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, or low-grade epithelial tumours.Participants with history of (non-infectious) ILD/pneumonitis that required steroids, or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.Participants with non-healing wound, active ulcer, or bone fracture (not applicable if not receiving bevacizumab).Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab).Participants with prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC).
StudyTREVI-OC-03
SponsorAstraZeneca
Study typeInterventional
Conditions
Ovarian cancerFallopian tube cancerPeritoneal cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT07816666
