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EPV066/#382 Preliminary results of niraparib and brivanib dual therapy evaluation in recurrent, metastatic and persistent cervical cancer (CQGOG0101: an open-label, single arm, phase II clinical trial
  1. D Zou,
  2. H Wang,
  3. J Shu and
  4. Q Zhou
  1. Chongqing University Cancer Hospital, The Gynecologic Oncology Center, Chongqing, China


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).

Abstract EPV066/#382 Figure 1

Study design

Abstract EPV066/#382 Table 1

Brief inclusion and exclusion criteria

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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