Phase 2 Study of APL-2 with Pembrolizumab Alone or Combined with Bevacizumab Compared to Bevacizumab Alone for Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer with Malignant Effusion

What this Trial Is About

Researchers are evaluating the effects of APL-2 combined with pembrolizumab, or with pembrolizumab and bevacizumab, compared to bevacizumab alone in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer who have malignant effusion. This phase II trial aims to assess whether APL-2 can help limit tumor progression, reduce malignant fluid buildup, and enhance the immune response against cancer cells. Immunotherapy drugs like pembrolizumab and bevacizumab are being studied for their potential to help the immune system attack cancer and interfere with tumor growth and spread. Participants are randomly assigned to different treatment groups receiving combinations of pegcetacoplan APL-2, pembrolizumab, and bevacizumab. Pegcetacoplan is given intravenously on the first day of the first cycle and then subcutaneously twice weekly during each cycle. Pembrolizumab and bevacizumab are administered intravenously on the first day of each cycle. Treatment cycles repeat every three weeks for up to seven cycles unless disease progression or unacceptable side effects occur. Pembrolizumab may be continued for up to 35 cycles. Tumor biopsies and blood samples are collected throughout the study to monitor immune and biological changes. Participants undergo regular assessments including the volume of malignant effusion drained every three weeks, quality of life questionnaires, and monitoring for adverse events. After completing treatment, follow-up visits occur at 30 days and then every 12 weeks to evaluate outcomes such as progression-free survival, overall survival, response rates, and quality of life. The study also includes exploratory analyses of immune system changes, tumor environment, and microbiome from collected samples. The total participation duration may extend up to three years for some outcome measurements.

APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion