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A Randomized Phase 2 Study of Bevacizumab and Either Weekly Anetumab Ravtansine or Weekly Paclitaxel in Platinum-Resistant or Platinum Refractory Ovarian Cancer
This phase II trial studies the side effects of bevacizumab and anetumab ravtansine or paclitaxel in treating participants with ovarian, fallopian tube, or primary peritoneal cancer that does not respond to treatment. Monoclonal antibodies, such as bevacizumab and anetumab ravtansine, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving bevacizumab and anetumab ravtansine or paclitaxel may work better in treating participants with ovarian, fallopian tube, or primary peritoneal cancer.
Primary objectives: To assess the safety and tolerability of the combination of weekly anetumab and bi-weekly bevacizumab. To determine whether the progression free survival (PFS) of the combination weekly anetumab and bi-weekly bevacizumab is superior to weekly paclitaxel and bi-weekly bevacizumab. Secondary Objectives: To determine the overall response rate (ORR) according to RECIST v1.1. To evaluate the PK profiles of weekly anetumab in serum and in peripheral blood mononuclear cells (PBMCs). To evaluate anti-drug antibody (ADA) titers (only for patients receiving anetumab). To evaluate mononuclear phagocyte system (MPS) function, Fc-gamma receptors (FcxRs), hormone and chemokine mediators. To correlate the expression of CA125 (IHC & serum) with mesothelin expression in archival tissue and circulating megakaryocyte potentiating factor (MPF). To investigate blood-based angiome profiling as a potential biomarker. To characterize the molecular profile of archival tumor tissue using the Oncomine panel, and explore whether genomic mutations such as BRCA1/2 and homologous repair deficiency status are associated with clinical outcome. Exploratory Objective: To assess tumor tissue-based VEGF-dependent gene expression signature as a biomarker of response.
Anetumab Ravtansine (BAY 94-9343) (); Avastin (Bevacizumab); Bevacizumab (); Taxol (paclitaxel); paclitaxel ()