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Clinical trial
ICON 9—an international phase III randomized study to evaluate the efficacy of maintenance therapy with olaparib and cediranib or olaparib alone in patients with relapsed platinum-sensitive ovarian cancer following a response to platinum-based chemotherapy
  1. Osnat Elyashiv1,
  2. Jonathan Ledermann1,2,
  3. Gita Parmar1,
  4. Laura Farrelly1,
  5. Nicholas Counsell1,
  6. Amanda Feeney1,
  7. Fatima El-Khouly3,
  8. Ian Macdonald1,
  9. Andreia Neto1,
  10. Esther Arthur-Darkwa1,
  11. Eva Burnett1,
  12. Gordon C Jayson4,5,
  13. Linda Mileshkin6,
  14. Charlie Gourley7 and
  15. Shibani Nicum8
  1. 1 University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London, UK
  2. 2 UCL Cancer Institute, University College, London, UK
  3. 3 Barking Havering and Redbridge University Hospitals NHS Trust, Romford, UK
  4. 4 Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK
  5. 5 Division of Cancer Science, The University of Manchester Faculty of Biology Medicine and Health, Manchester, UK
  6. 6 Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
  7. 7 Nicola Murray Centre for Ovarian Cancer Research, CRUK Edinburgh Centre, MRC IGMM, University of Edinburgh, Edinburgh, UK
  8. 8 Oxford University Hospitals NHS Trust, Oxford, UK
  1. Correspondence to Dr Osnat Elyashiv, University College CRUK and UCL Cancer Trials Centre, UCL Cancer Institute, London WC1E 6DD, UK; osnatelyashiv{at}gmail.com

Abstract

Background Two novel biological agents—cediranib targeting angiogenesis, and olaparib targeting DNA repair processes—have individually led to an improvement in ovarian cancer control. The aim of ICON9 is to investigate the combination of cediranib and olaparib maintenance in recurrent ovarian cancer following platinum-based therapy.

Primary objective To assess the efficacy of maintenance treatment with olaparib in combination with cediranib compared with olaparib alone following a response to platinum-based chemotherapy in women with platinum-sensitive ovarian, fallopian tube or peritoneal cancer during first relapse.

Study hypothesis Maintenance therapy with cediranib and olaparib in combination is associated with improved patient outcomes compared with olaparib alone.

Trial design International phase III randomized controlled trial. Following a response to platinum-based chemotherapy patients are randomized 1:1 to either oral olaparib and cediranib (intervention arm) or oral olaparib alone (control arm).

Major inclusion criteria Patients with a known diagnosis of high grade serous or endometrioid carcinoma of the ovary, fallopian tube or peritoneum, progressing more than 6 months after first-line platinum-based chemotherapy, who have responded to second-line platinum-based chemotherapy.

Primary endpoints Progression-free and overall survival. Co-primary endpoints to be assessed using a fixed-sequence gatekeeping approach: (1) progression-free survival, all patients; (2) progression-free survival, BRCA wild type; (3) overall survival, all patients; (4) overall survival, BRCA wild type.

Sample size 618 patients will be recruited.

Estimated dates for completing accrual and presenting results Accrual is expected to be completed in 2024 with presentation of results in 2025.

Trial registration ClinicalTrials.gov: NCT03278717.

  • ovarian cancer
  • medical oncology
  • fallopian tube neoplasms
  • peritoneal neoplasms

https://doi.org/10.1136/ijgc-2020-002073

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    Footnotes

    • Contributors OE, JAL: original draft; SN, JAL, LF, AF, NC, FEK, GCJ, LM, CG: study conception, design, and methodology, supervision; NC: statistics; LF, AF: project management; GP, IM: trial management; AN, EAD: data collection; EB: patient representative. All authors revised, edited, and approved the final version of the protocol.

    • Funding The trial has public funding in the UK from Cancer Research UK (A19714 CRUK/15/074). In Australia, the ICON9 trial was awarded through the Priority-driven Collaborative Cancer Research Scheme and is funded by Cancer Australia (1100619). AstraZeneca are providing trial drugs (cediranib and olaparib) as well as support for translational research. AstraZeneca are also providing some support for international participation, although each group is required to obtain local funding to manage and co-ordinate the trial within their country. The co-ordination, management and oversight of the trial are provided by the sponsor UCL and the Cancer Research UK and UCL Cancer Trials Centre. IQVIA are conducting on-site monitoring on behalf of the sponsor. The co-ordination of the trial in Australia and New Zealand is provided by Australia New Zealand Gynaecological Oncology Group (ANZGOG).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement No data are available.