Phase 3 Trial of Trastuzumab Deruxtecan Plus Bevacizumab Versus Bevacizumab Alone as First-Line Maintenance Therapy for HER2-Expressing Advanced Ovarian Cancer

What this Trial Is About

Researchers are evaluating the combination of Trastuzumab Deruxtecan T-DXd with bevacizumab compared to bevacizumab alone as a first-line maintenance therapy in adults with advanced high-grade epithelial ovarian cancer that expresses HER2. This Phase 3 trial includes a safety run-in phase to check how well participants tolerate T-DXd combined with bevacizumab before randomization. The study focuses on participants newly diagnosed with FIGO Stage III or IV ovarian, fallopian tube, or primary peritoneal carcinoma, who have HER2 expression confirmed by central testing. Participants are assigned to one of two groups one receiving T-DXd at 5.4 mgkg intravenously every 3 weeks plus bevacizumab at 15 mgkg intravenously every 3 weeks, and the other receiving bevacizumab alone at the same dose and schedule. Before randomization, a safety run-in phase will assess the safety of the combination treatment. The study is open-label and multicenter, designed to compare the treatments as first-line maintenance therapy after initial chemotherapy. During the trial, participants will be closely monitored through radiographic assessments to measure progression-free survival and overall survival, particularly focusing on HER2 expression levels. Researchers will evaluate safety and effectiveness over follow-up periods of up to approximately 35 and 72 months, respectively. Tumor tissue samples and genetic testing results will be collected to support evaluations. Participant involvement includes signing informed consent, undergoing central HER2 testing, and regular treatment and monitoring visits throughout the study duration.

Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)