A multicenter phase II randomized trial of durvalumab (MEDI-4736) versus physician's choice chemotherapy in recurrent ovarian clear cell adenocarcinoma (MOCCA)
| Autor: | Hee Seung Kim, Michael Friedlander, Nivashini Kaliaperumal, John E. Connolly, Geraldine Goss, Jae Weon Kim, Jeffrey C. Goh, DIana G.Z. Lim, Bee Choo Tai, Natalie Ngoi, Wen Yee Chay, Kidong Kim, David S.P. Tan, Samuel Ow, Valerie Heong, Veonice Bijin Au, Chel Hun Choi |
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| Rok vydání: | 2020 |
| Předmět: |
Oncology
medicine.medical_specialty Durvalumab medicine.medical_treatment Antineoplastic Agents law.invention 03 medical and health sciences 0302 clinical medicine Antineoplastic Agents Immunological Randomized controlled trial Ovarian Clear Cell Adenocarcinoma law Internal medicine medicine Clinical endpoint Humans Immune Checkpoint Inhibitors Response Evaluation Criteria in Solid Tumors 030304 developmental biology Ovarian Neoplasms 0303 health sciences Chemotherapy Performance status business.industry Obstetrics and Gynecology Antibodies Monoclonal medicine.disease Clinical Trial Progression-Free Survival Survival Rate ovarian cancer 030220 oncology & carcinogenesis Clear cell carcinoma Female Neoplasm Recurrence Local Ovarian cancer business Adenocarcinoma Clear Cell |
| Zdroj: | International Journal of Gynecological Cancer |
| ISSN: | 1525-1438 |
| Popis: | BackgroundThe 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 objectiveTo evaluate the efficacy of durvalumab (MEDI-4736) compared with standard chemotherapy in patients with recurrent ovarian clear cell carcinoma.Study hypothesisPatients 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 designThe 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 criteriaEligible 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 endpointsThe 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 sizeThe target sample size was 46 patients.Estimated dates for completing accrual and presenting resultsAccrual has been completed and results are expected to be presented by mid-2021.Trial registrationClinicaltrials.gov: NCT03405454. |
| Databáze: | OpenAIRE |
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