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Clinical trial
A multicenter phase II randomized trial of durvalumab (MEDI-4736) versus physician’s choice chemotherapy in recurrent ovarian clear cell adenocarcinoma (MOCCA)
  1. Natalie YL Ngoi1,
  2. Valerie Heong2,
  3. Samuel Ow1,
  4. Wen Yee Chay3,
  5. Hee Seung Kim4,
  6. Chel Hun Choi5,
  7. Geraldine Goss6,
  8. Jeffrey C Goh7,8,
  9. Bee Choo Tai9,10,
  10. Diana GZ Lim11,
  11. Nivashini Kaliaperumal12,
  12. Veonice B Au12,
  13. John E Connolly12,13,
  14. Jae-Weon Kim4,
  15. Michael Friedlander14,15,
  16. Kidong Kim16 and
  17. David SP Tan1,10,17
  1. 1Department of Haematology-Oncology, National University Cancer Institute, Singapore
  2. 2Department of Medical Oncology, Tan Tock Seng Hospital, Singapore
  3. 3Division of Medical Oncology, National Cancer Centre Singapore, Singapore
  4. 4Department of Obstetrics and Gynecology, Seoul National University, Seoul, Republic of Korea
  5. 5Department of Obstetrics and Gynecology, Samsung Medical Center, Seoul, Republic of Korea
  6. 6Box Hill Hospital, Box Hill, Victoria, Australia
  7. 7Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
  8. 8The University of Queensland, Saint Lucia, Queensland, Australia
  9. 9Saw Swee Hock School of Public Health, National University of Singapore, Singapore
  10. 10Yong Loo Lin School of Medicine, National University of Singapore, Singapore
  11. 11Department of Pathology, National University Hospital, Singapore
  12. 12Institute of Molecular and Cell Biology, Agency for Science, Technology and Research, Singapore
  13. 13Institute of Biomedical Studies, Baylor University, Waco, Texas, USA
  14. 14The Prince of Wales Hospital, Randwick, New South Wales, Australia
  15. 15Prince of Wales Clinical School University of New South Wales, Randwick, New South Wales, Australia
  16. 16Seoul National University Bundang Hospital, Seoul, Republic of Korea
  17. 17Cancer Science Institute Singapore, Singapore
  1. Correspondence to Dr David SP Tan, Cancer Science Institute, National University of Singapore and National University Cancer Institute, SIngapore, National University Health System, Singapore 119074, Singapore; david_sp_tan{at}nuhs.edu.sg

Abstract

Background The optimal treatment of recurrent ovarian clear cell carcinoma remains unknown. There is increasing rationale to support the role of immune checkpoint inhibitors targeting the programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) axis in ovarian clear cell carcinoma.

Primary objective To evaluate the efficacy of durvalumab (MEDI-4736) compared with standard chemotherapy in patients with recurrent ovarian clear cell carcinoma.

Study hypothesis Patients with recurrent ovarian clear cell carcinoma treated with durvalumab will have improved progression-free survival compared with those treated with chemotherapy of physician’s choice.

Trial design The MOCCA study is a multicenter, open-label, randomized phase II trial in patients with recurrent ovarian clear cell carcinoma, which recruited from eight sites across Gynecologic Cancer Group Singapore (GCGS), Korean Gynecologic-Oncology Group (KGOG), and Australia New Zealand Gynecological Oncology Group (ANZGOG). Enrolled patients were randomized in a 2:1 ratio to receive durvalumab or physician’s choice of chemotherapy until disease progression, intolerable toxicity, or withdrawal of patient consent.

Major inclusion/exclusion criteria Eligible patients required histologically documented diagnosis of recurrent ovarian clear cell carcinoma, as evidenced by WT1 negativity. All patients must have been of Eastern Cooperative Oncology Group (ECOG) performance status 2 or better, and have had previous treatment with, and progressed or recurred after prior platinum-based chemotherapy. No more than four prior lines of treatment were allowed and prior immune checkpoint inhibitor treatment was not permitted.

Primary endpoints The primary endpoint was the median progression-free survival following treatment with durvalumab, compared with physician’s choice of chemotherapy. Progression-free survival was defined as the time from the first day of treatment to the first observation of disease progression, or death due to any cause, or last follow-up.

Sample size The target sample size was 46 patients.

Estimated dates for completing accrual and presenting results Accrual has been completed and results are expected to be presented by mid-2021.

Trial registration Clinicaltrials.gov: NCT03405454.

  • ovarian cancer
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/ijgc-2020-001604

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    Footnotes

    • Twitter @KIDONG_KIM_MD

    • Contributors Conceptualization: all authors data curation: NYLN writing–original draft preparation: NYLN writing–review and editing: all authors visualization: all authors supervision: DT project administration: Vilianty.

    • Funding This study is funded by the Ministry of Health National Medical Research Council Singapore (NMRC/MOHIAFCat1/0061/2016) and AstraZeneca. DT is supported by the National Medical Research Council Singapore CSAINV16may008.

    • Competing interests VH has received honoraria from AstraZeneca. SO has received honoraria from AstraZeneca. JCG has received honoraria and sponsorship to attend a conference from AstraZeneca. DT has received honoraria and research funding from AstraZeneca. MF has received honoraria and research funding from Astra Zeneca.

    • Patient consent for publication Not required.

    • Provenance and peer review Commissioned; internally peer reviewed.

    • Data availability statement No data are available.