Phase 2 Study of Pembrolizumab and Bevacizumab With or Without Anti-CD40 CDX-1140 for Women With Recurrent Ovarian Cancer

What this Trial Is About

Researchers are evaluating a phase II clinical trial studying pembrolizumab combined with bevacizumab, with or without the addition of an agonist anti-CD40 antibody called CDX-1140, in patients with recurrent ovarian cancer. This trial aims to test whether these immunotherapy treatments can shrink tumors by stimulating the immune system to attack cancer cells. The study also seeks to assess safety, tumor response, survival outcomes, and changes in quality of life. Participants are randomly assigned to one of two groups. One group receives pembrolizumab and bevacizumab intravenously every three weeks, while the other group receives the same treatments plus CDX-1140 intravenously every three weeks. Treatment continues until the disease progresses or unacceptable side effects occur. After treatment ends, participants have follow-up visits at 30 days and then every six months for two years. During the study, researchers will monitor side effects and evaluate tumor response using immune-related criteria. Quality of life questionnaires and fatigue assessments will be completed throughout. Blood and tissue samples will be collected to study immune changes, biomarkers, and the microbiome. Participants will be closely observed for up to two years to assess progression-free survival and overall survival, with regular assessments to track health and treatment effects.

Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer