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Not Yet Recruiting NCT07816666

Torvutatug Samrotecan With or Without Bevacizumab as Maintenance Treatment of Platinum-sensitive Relapsed Epithelial Ovarian Cancer

Conditions: Platinum-sensitive Relapsed Epithelial Ovarian Cancer, Platinum-sensitive Relapsed Fallopian Tube Cancer, Platinum-sensitive Relapsed Primary Peritoneal Cancer

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 600
Sponsor: AstraZeneca

Location: Research Site Anchorage Alaska

Summary

The purpose of this study is to measure the efficacy and safety of torvutatug samrotecan (torvu-sam) with or without bevacizumab compared to standard of care (SoC) as maintenance treatment in participants with platinum-sensitive relapsed ovarian cancer (PSR OC)

Eligibility Criteria

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 at least 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07816666). StuddyBuddy aggregates publicly available trial information.