Abstract
PURPOSE: The optimal treatment of recurrent ovarian clear cell carcinoma (rOCCC) remains unknown. This is the first randomized trial to compare durvalumab with chemotherapy in rOCCC. PATIENTS AND METHODS: MOCCA is a randomized, phase 2 trial conducted in Singapore, Korea, and Australia. Eligible patients had rOCCC with recurrence after platinum-based chemotherapy, Eastern Cooperative Oncology Group performance status ≤2, and no prior immune checkpoint blockade. Patients were randomly assigned (2:1) to durvalumab (1,500 mg every 4 weeks) or chemotherapy. Patients progressing on chemotherapy were allowed to cross over to durvalumab. The primary outcome was progression-free survival. Secondary outcomes included overall survival, objective response rates, and safety. RESULTS: Forty-eight eligible women were assigned to durvalumab (N = 31) or chemotherapy (N = 17). The median progression-free survival was 7.6 [95% confidence interval (CI), 7.0-16.0] and 14.0 (95% CI, 7.0-32.9) weeks with durvalumab and chemotherapy, respectively (HR = 1.6; 95% CI, 0.8-3.0; P = 0.92). The median overall survival was 37.9 (95% CI, 21.7-143.0) and 40.6 (95% CI, 25.0-not reached) weeks, respectively (HR = 1.5; 95% CI, 0.7-3.3; P = 0.85). The difference in objective response rates between the groups was not statistically significant (durvalumab 9.7% vs. physician's choice chemotherapy 18.8%; difference -9.1%; 95% CI, -31.3% to 12.9%; P = 0.83). Fewer all-grade (35.5% vs. 68.8%) and high-grade (9.7% vs. 31.3%) treatment-related adverse events were observed for durvalumab. PD-L1 combined positive score (CPS)+ was observed in 28.9% (CPS ≥1%) and 10.5% (CPS ≥10%) of patients. PIK3CA mutations were associated with time to progression on durvalumab ≥12 weeks [relative risk (mutated vs. wild-type) 2.83; 95% CI, 1.16-14.17]. CONCLUSIONS: Durvalumab was well-tolerated but did not improve efficacy outcomes compared with chemotherapy in rOCCC.