Torvutatug samrotecan with or without bevacizumab as maintenance in platinum-sensitive relapsed epithelial ovarian, fallopian tube, or primary peritoneal 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 phase 3 interventional trial compares torvutatug samrotecan, alone or combined with bevacizumab, against standard maintenance care in patients with platinum‑sensitive relapsed high‑grade ovarian, fallopian tube, or primary peritoneal cancer. Eligible participants have limited prior systemic therapy, a radiologic relapse after at least 6 months from platinum, and adequate prior exposure to bevacizumab if assigned. The study uses archival tumor tissue for biomarker considerations and requires a recurrence timeframe and response to prior treatment to guide randomization. Primary outcomes focus on efficacy and safety of the regimens in this maintenance setting, with multicenter sites in the United States.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Participants with confirmed histology of high-grade epithelial serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer.
* Provision of an archival FFPE tumour sample
* Participants who received at least one, and no more than 2 lines of prior systemic anticancer therapy.
* Participants with radiologically confirmed disease relapse ≥ 6 months after their last platinum chemotherapy infusion in the previous line of treatment
* Participants who received 4-6 cycles of PBC during the induction phase of their current line of treatment.
* Participants assigned to bevacizumab must have received a minimum of 3 cycles of bevacizumab with 3 cycles of PBC prior to randomisation.
* Participants with non-progressive disease upon completion of PBC in their current line of treatment.
* Participants with documented BRCA mutation 1/2 must have received prior PARP inhibitor (unless ineligible due to contraindications, precautions, or intolerance).

Exclusion Criteria:

* Participants with tumours of non-epithelial origin, borderline tumours, clear cell OC, mucinous OC, carcinosarcoma, 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 (not applicable if not receiving bevacizumab)
* Participants with evidence of active or ongoing bowel obstruction (not applicable if not receiving bevacizumab)
* Participants with prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)

Where it's running

• Research Site
  Seoul, South Korea Recruiting
• Research Site
  Taichung, Taiwan Recruiting
• Research Site
  Tainan, Taiwan Recruiting
• Research Site
  Anchorage, Alaska, United States Not yet recruiting
• Research Site
  Miami, Florida, United States Not yet recruiting
• Research Site
  Indianapolis, Indiana, United States Not yet recruiting

+74 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.