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Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer

950 patients around the world
Available in Argentina, Brazil, Chile, Colombia, Peru, United States
This study aims to see if torvu-sam in combination with bevacizumab allows patients to live longer without the cancer getting worse, compared to patients receiving bevacizumab. Eligible patients will be those patients who have not progressed following completion of first line induction treatment with Platinum-based chemotherapy (PBC) and bevacizumab. All patients must be HRD-negative through pre-existing study approved local test or prospective central test and have a confirmed folate receptor alpha status determined by prospective central test.
AstraZeneca
950Patients around the world

This study is for people with

Ovarian cancer

Requirements for the patient

From 18 Years
Female

Medical requirements

Participants with newly diagnosed FIGO Stage III/IV, histologically confirmed epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma.
Provision of an archival FFPE tumour sample.
Participants who have completed at least 6 cycles and a maximum of 8 cycles of first-line Platinum-based chemotherapy (PBC) prior to randomisation.
Participants must have received a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of PBC, prior to randomisation.
Participants who have completed cytoreductive surgery or have inoperable disease.
Participants with non-progressive disease upon completion of front-line induction therapy.
HRD negative tumour.
Participants with tumours of non-epithelial origin, borderline tumours, 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.
Participants with evidence of active or ongoing bowel obstruction.
Prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC).
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