EP0057 in Combination With Olaparib in Advanced Ovarian Cancer

Summary

Participation Requirements

Description

EP0057-201 is an adaptive Phase 2A/B study in patients with advanced ovarian cancer. Phase 2A Phase 2A will be comprised of 2 single-arm treatment cohorts: Cohort 1 will explore EP0057 in combination with Olaparib in patients with advanced platinum resistant ovarian cancer (see inclusion criteria fo...

EP0057-201 is an adaptive Phase 2A/B study in patients with advanced ovarian cancer. Phase 2A Phase 2A will be comprised of 2 single-arm treatment cohorts: Cohort 1 will explore EP0057 in combination with Olaparib in patients with advanced platinum resistant ovarian cancer (see inclusion criteria for definition of platinum resistant) who are PARP inhibitor naive and who have received no more than 1 prior line of therapy which must be platinum-based chemotherapy (n~=30) Cohort 2 will explore EP0057 in combination with Olaparib in patients with advanced ovarian cancer who have received at least 1 prior line of therapy which must include at least 1 line of platinum-based chemotherapy followed by a PARP inhibitor as maintenance treatment as their last treatment regimen (n~=30) It is anticipated that up to approximately 60 patients (approximately 30 patients per cohort) will be enrolled into Phase 2A. Both treatment cohorts will open in parallel and patients will be enrolled into each cohort concurrently. At the end of Phase 2A, the Safety Review Committee will guide the decision to initiate 1 or both cohorts in Phase 2B, or terminate further recruitment into the study. Phase 2B Phase 2B will be comprised of 2 treatment cohorts, each randomised versus SOC. One or both cohorts may be opened concurrently to recruitment: Cohort 1 will explore EP0057 in combination with Olaparib compared with SOC chemotherapy (TBC) in patients with advanced platinum resistant ovarian cancer who are PARP inhibitor naive and who have received no more than 1 prior line of therapy which must be platinum-based chemotherapy (n=~132) Cohort 2 will explore EP0057 in combination with Olaparib compared with SOC chemotherapy (TBC) in patients with advanced ovarian cancer who have received at least 1 prior line of therapy which must include at least 1 line of platinum-based chemotherapy followed by a PARP inhibitor as maintenance treatment as their last therapy (n=~192) It is anticipated that ~324 patients will be enrolled into Phase 2B. Both treatment cohorts may open in parallel and patients may be enrolled into each cohort concurrently.

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