A Randomized Phase 3 Trial Comparing QL1706 Plus Bevacizumab Versus Standard Platinum-Based Chemotherapy With or Without Bevacizumab as First-Line Treatment for Advanced Ovarian Clear Cell Carcinoma

What this Trial Is About

Researchers are evaluating the use of QL1706 combined with bevacizumab to treat adult female patients aged 18 to under 75 years with newly diagnosed advanced ovarian clear cell carcinoma, specifically FIGO stage IC-IV. This phase 3 trial aims to determine if this combination can improve progression-free survival compared to standard platinum-based chemotherapy with or without bevacizumab. The study also assesses the safety and side effects experienced by participants during treatment. Participants are randomly assigned to one of two groups the experimental arm receiving QL1706 alone during the first cycle followed by QL1706 plus bevacizumab from the second cycle, or the control arm receiving standard chemotherapy with paclitaxel and carboplatin, with or without bevacizumab based on risk factors. QL1706 is given intravenously every three weeks at 5 mgkg for up to two years, while bevacizumab is administered every three weeks at 15 mgkg for up to 22 cycles or until disease progression or intolerable side effects. Chemotherapy is given every three weeks for six cycles, with bevacizumab possibly continued as per criteria. Throughout the study, participants visit the research center regularly to receive infusions, undergo medical exams including vital signs, lab tests, and tumor imaging scans, and complete quality of life questionnaires. Researchers monitor outcomes such as progression-free survival over up to four years, overall survival, time to subsequent therapies, and treatment-related adverse events. The study includes ongoing safety evaluations and quality of life assessments during treatment and follow-up periods.

INVIGORATE: A Study of QL1706 and Bevacizumab in Advanced First-Line Ovarian Clear Cell Carcinoma