Introduction Oregovomab, a murine IgGκ monoclonal antibody binds to tumor-associated antigen, CA125, rendering target antigen CA125 more immunogenic through enhanced antigen processing and presentation to specific T cells, bypassing tumor-associated suppression and resulting in enhanced efficacy of chemotherapy. In a randomized phase II study, oregovomab (O) in combination with paclitaxel and carboplatin (PC) demonstrated significant improvement in mPFS (months) 41.8 PCO vs 12.3 PC, HR=0.46, p=0.0027 and OS median N.E. PCO vs 43.2 PC, HR=0.35, p=0.043.
Methods This is a phase 2, double-blind, placebo-controlled, multi centered clinical trial. Patients with FIGO III/IV EOC and serum CA125 ≥ 50 U/ml receiving neoadjuvant chemotherapy will be randomized. In each arm patients will receive oregovomab/placebo at cycles 1 and 3 in combination with chemotherapy prior to interval debulking surgery, followed by oregovomab/placebo at cycles 4 and 6 in combination with chemotherapy, and oregovomab/placebo monotherapy at cycle 6 plus12 weeks. The objective of this study is to confirm that the presence of primary tumor and its immune suppressive biology does not interfere with chemoimmunotherapy when oregovomab is administered with initiation (Cycle 1) of chemotherapy did not delay timing of cytoreductive surgery. The primary objective of the study is to evaluate the PFS Rate at 12 months. Secondary objectives include investigator assessed ORR and DCR by RECIST v1.1, PFS, OS, Response to surgery, safety and tolerability.
Current Trial Status Of the 88 patients enrolment target of the study, 31 patients have been enrolled from 14 centers at the time of submission.
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