This study will evaluate the efficacy, safety and tolerability of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab monotherapy as first line maintenance treatment in patients with Homologous Recombination Deficient (HRD) negative advanced ovarian cancer.
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 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
Parallel
Torvutatug samrotecan
DrugAntibody drug conjugate
Bevacizumab
DrugMonoclonal antibody inhibitor of Vascular Endothelial Growth Factor
Progression Free Survival (PFS)
PFS is defined as the time from randomization to radiographic progression as assessed by BICR per RECIST v1.1, or death due to any cause.
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Second progression free survival (PFS2)
PFS2 is defined as time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression) after first subsequent therapy, or death.
Time to First Subsequent Therapy (TFST)
TFST is defined as time from randomisation until the start date of the first subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.
Time to Second Subsequent Therapy (TSST)
TSST is defined as time from randomisation until the start date of the second subsequent anti-cancer therapy after discontinuation of randomised treatment, or death due to any cause.
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AstraZeneca
Lead sponsor
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
GOG Foundation
Collaborator
