A Phase 3, multicenter, randomized, open-label study designed to evaluate Mocertatug Rezetecan in combination with Bevacizumab compared with a platinum-based doublet regimen in combination with Bevacizumab in participants with platinum-sensitive ovarian cancer.
Principal Investigator
Dott.ssa Mariastella Bungaro
Contact Information for Access
Phase
FASE III
Status
IN ATTIVAZIONE
Objective of the study
To evaluate the clinical efficacy of Mocertatug Rezetecan (Mo-Rez) in combination with Bevacizumab compared with a platinum-based doublet regimen plus Bevacizumab followed by maintenance therapy with Bevacizumab in participants with platinum-sensitive ovarian cancer (PSOC).
ClinicalTrials.gov ID: NCT07684612
Sponsor: GlaxoSmithKline
Pathologies
Gynecologic cancers (gynecological tumors)
Medication
Mocertatug Rezetecan + Bevacizumab vs. Platinum Doublet + Bevacizumab.
Who is eligible to participate in the study?
The study includes adult female patients (≥18 years) with epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with confirmed histology (high-grade serous, high-grade endometrioid, clear cell carcinoma, or carcinosarcoma).
Patients must have recurrent or progressive disease following 1–2 prior lines of systemic therapy, with platinum-sensitive disease (recurrence/progression >6 months after the last platinum-based therapy) and eligibility to receive platinum-based doublet chemotherapy in combination with bevacizumab.
Tumor tissue must be available for the central assessment of B7-H4 expression and for documenting the BRCA1/2 mutational status.
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