Torvutatug samrotecan plus bevacizumab as first-line maintenance in non-HRD advanced epithelial ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional study comparing torvu-samrotecan plus bevacizumab versus bevacizumab alone as maintenance therapy after first-line platinum-based chemotherapy in non-HRD advanced epithelial ovarian cancer. Eligible participants have completed induction therapy with no progression and have received prior bevacizumab. The study will assess efficacy, safety, and tolerability, focusing on progression-free survival and related outcomes. Tumor samples must be available, and participants should have non-HRD status confirmed. Sites are in Florida and Louisiana, sponsored by AstraZeneca with ENGOT and GOG Foundation collaboration.

Why it matters

Who can join: the full rules

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

Key Exclusion Criteria:

* Participants with tumours of non-epithelial origin, borderline tumours, or low-grade epithelial tumours
* BRCA1/2 mutation (germline or somatic) or HRD positive, unknown, or inconclusive tumour status
* 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)

Where it's running

• Research Site
  Auchenflower, Australia Recruiting
• Research Site
  Hadera, Israel Recruiting
• Research Site
  Haifa, Israel Recruiting
• Research Site
  Jerusalem, Israel Recruiting
• Research Site
  Tamarac, Florida, United States Not yet recruiting
• Research Site
  Tampa, Florida, United States Not yet recruiting

+170 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.