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

RecruitingPhase 3Ages 18 Years - anyFemaleAstraZeneca
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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 FRฮฑ-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)
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What it tests

  • Torvutatug samrotecan
  • Bevacizumab
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Where

186 sites
Research Site
Tampa, United States
Research Site
Baltimore, United States
Research Site
Billings, United States
Research Site
Cleveland, United States
Research Site
Buenos Aires, Argentina
Research Site
Buenos Aires, Argentina
Research Site
Capital Federal, Argentina
Research Site
Ciudad de Buenos Aires, Argentina

โ€ฆand 178 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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