Study on Torvutatug Samrotecan With or Without Bevacizumab for Maintenance Treatment of Platinum-sensitive Relapsed Ovarian Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07816666

This clinical trial is testing the effectiveness and safety of a new drug, torvutatug samrotecan, with or without bevacizumab, compared to the usual treatment for women with ovarian cancer that has returned and responds to platinum-based chemotherapy.

Patient Parameters

Program Overview

The aim of this study is to evaluate how well the drug torvutatug samrotecan, either alone or combined with bevacizumab, works as a maintenance treatment for women whose ovarian cancer has returned but still responds to platinum-based chemotherapy. The study will compare this new treatment to the standard care currently used for such cases.

Eligibility Criteria

Inclusion Criteria

  • Women with confirmed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer.
  • Must provide a previous tumor sample for analysis.
  • Have received at least one, but no more than two, previous cancer treatments.
  • Cancer must have returned at least 6 months after the last platinum chemotherapy treatment.
  • Have completed 4-6 cycles of platinum-based chemotherapy in their current treatment phase.
  • If assigned to receive bevacizumab, must have had at least 3 cycles of bevacizumab with 3 cycles of platinum-based chemotherapy before starting the study.
  • Cancer must not be progressing after completing the current chemotherapy.
  • If they have a BRCA 1/2 mutation, must have previously received a PARP inhibitor unless unable to due to medical reasons.

Exclusion Criteria

  • Have tumors that are not epithelial in origin, or have borderline, clear cell, mucinous, carcinosarcoma, or low-grade epithelial tumors.
  • Have a history of lung conditions like ILD/pneumonitis that needed steroids or oxygen, or currently have these conditions.
  • Have a non-healing wound, active ulcer, or bone fracture (if receiving bevacizumab).
  • Have an active or ongoing bowel obstruction (if receiving bevacizumab).
  • Have previously been treated with any FRα-targeted therapy or certain antibody-drug conjugates.

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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