Clareo Health | Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Homologous Recombination Deficiency (HRD) Negative Advanced Epithelial Ovarian Cancer
European Network of Gynaecological Oncological Trial Groups (ENGOT)
GOG Foundation
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
