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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07816666

This study evaluates the efficacy and safety of torvutatug samrotecan, a FRa-targeting antibody drug conjugate, with or without bevacizumab, a VEGF inhibitor, in PSR OC patients. Eligible participants have high-grade epithelial ovarian cancer, received 1-2 prior therapies, and show non-progressive disease post-platinum chemotherapy. BRCA mutation carriers must have prior PARP inhibitor exposure.

Patient Parameters

Program Overview

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 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)

Locations

FACILITYZIPCITYSTATE
Research Site99508AnchorageAlaska
Research Site33133MiamiFlorida
Research Site46260IndianapolisIndiana
Research Site71103ShreveportLouisiana
Research Site21044ColumbiaMaryland
Research Site48109Ann ArborMichigan
Research Site48201DetroitMichigan
Research Site12206AlbanyNew York
Research Site11706Bay ShoreNew York
Research Site14263BuffaloNew York

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