OPERA: a phase II trial of oregovomab plus non-platinum chemotherapy in PARP inhibitor/platinum-resistant ovarian cancer

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Authors: Junsik Park ; Hyun Woong Cho ; Myong Cheol Lim ; Chel Hun Choi ; Jung-Yun Lee

MeSH: Adult ; Aged ; Antibodies, Monoclonal / administration & dosage ; Antibodies, Monoclonal / therapeutic use ; Antineoplastic Combined Chemotherapy Protocols* / adverse effects ; Antineoplastic Combined Chemotherapy Protocols* / therapeutic use ; Clinical Trials, Phase II as Topic ; Drug Resistance, Neoplasm* ; Female ; Humans ; Middle Aged ; Multicenter Studies as Topic ; Ovarian Neoplasms* / drug therapy ; Ovarian Neoplasms* / mortality ; Ovarian Neoplasms* / pathology ; Poly(ADP-ribose) Polymerase Inhibitors* / administration & dosage ; Poly(ADP-ribose) Polymerase Inhibitors* / therapeutic use

Keywords: Antibody anti-CA125 ; indirect immunization ; oregovomab ; ovarian neoplasms ; recurrence ; resistant

Abstract: A consensus regarding subsequent therapeutic strategies for patients with platinum- and poly (ADP-ribose) polymerase inhibitor (PARPi)-resistant ovarian cancer is lacking. These patients typically receive non-platinum-based chemotherapy; however, survival outcomes remain poor. Compared with chemotherapy alone, combination therapy with novel target agents can provide additional benefits to these patients. Oregovomab, an investigational murine monoclonal antibody against CA-125, has shown promising efficacy in a phase II study in patients with recurrent ovarian cancer. Herein, we described the rationale and design of OPERA/KGOG 3065/APGOT-OV6, a multicenter, investigator-initiated, two-cohort, single-arm phase II trial, aimed at examining the efficacy of oregovomab plus non-platinum-based chemotherapy in patients with PARPi/platinum-resistant ovarian cancer. The primary end point was the objective response rate, according to RECIST 1.1.Clinical Trial Registration: NCT05407584 (ClinicalTrials.gov).