Objectives The aim of this study (CQGOG 0101) is to evaluate the safety and activity of Niraparib (an oral PARP1/2 inhibitor) combined with brivanib in patients with recurrent, metastatic, or persistent cervical cancer.
Methods The CQGOG0101 study is an open-label, single-arm, single-center, phase 2 trial.
Results Between May 8th, 2020 and Jan 22nd, 2021, 9 patients (median age, 50 years old [28–73]) were enrolled. Patients had received a median of two (1–3) previous lines of platinum-based therapy. All of nine patients had distant metastatic lesions and had underwent at least one post-baseline tumor assessment (To deadline for submission), including 1 confirmed partial response, 4 with stable disease, 4 with progressive disease. Median duration of treatment was 3.8 months (3–8.2), three patients were still on treatment. No drug-related grade 3 or worse treatment-emergent adverse events were detected, the most common grade 1–2 adverse events (AEs) included: neutropenia (4 of 9 patients), anemia (2 of 9 patients), thrombocytopenia (1 of 9 patients), hypertension (2 of 9 patients), proteinuria(1 of 9 patients), fatigue (1 of 9 patients), and increased ALT/AST (1 of 9 patients).
Conclusions This combo seems to show a similar efficacy compared to other recurrent cervical cancer late-line therapies. We are also seeking to amend the protocol and explore niraparib combined with immunotherapy in recurrent CC in our trial later. Clinical trial information: NCT04395612.
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