A Phase 2 interventional study of Olaparib-Pembrolizumab-Bevacizumab in Platinum-sensitive Recurrent BRCA Wild Type Ovarian Cancer, sponsored by Yonsei University. Status unknown at 1 site in South Korea. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by Yonsei University · Phase 2, Interventional, and Treatment
This study is phase II, open label, clinical trial to determine the efficacy of Olaparib maintenance with Bevacizumab and Pembrolizumab by assessment progression-free survival(6 months PFS rate) in BRCA non-mutated patients with platinum-sensitive recurrent ovarian cancer.
'This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and safety of Olaparib maintenance with Bevacizumab and Pembrolizumab in subjects with platinum-sensitive who have received prior of platinum-based chemotherapy. The study will assess the effectiveness of progression-free survival(6 months PFS rate) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The subject will be treated to until disease progression as below:
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's planned enrollment of 44 is below the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Participant has adequate organ function as defined in the following:
Exclusion Criteria:
BRCA mutation wild type, non-mucinous , platinum-sensitive recurrent ovarian cancer
Drug: Olaparib-Pembrolizumab-Bevacizumab
* Olaparib 300mg (twice daily \[BID\]) * Pembrolizumab 200mg every 3 weeks (Q3W) from 2nd infusion for up to 35 infusions * Bevacizumab 15mg/kg or 7.5mg/kg every 3 weeks (Q3W)
progression-free survival(6 months PFS rate)
To determine the clinical effectiveness of the study treatment assessed using progression free survival(6months) according to RECIST v1.1 criteria (Investigator determined)
Time frame: 6 months
Overall survival (OS)
Time frame: Up to 1year
Time to tumour progression (TTP)
Time frame: Up to 1year
Time to first subsequent treatment(or death)
Time frame: The date of first documented first subsequent treatment or date of death, assessed up to 72 months
Time to second subsequent treatment
Time frame: The date of first documented second subsequent treatment assessed up to 72 months
progression-free survival
Time frame: Up to 1year
Plan to share: No
Started Oct 2020 (actual). Primary completion is estimated for May 2026, 67 months after the start.
Of 203 non-industry phase 2 interventional studies under Ovarian Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 82. This study's planned 67 months is above that.
Counting every sponsor, half of 307 studies reached it within 47 months; a quarter within 33 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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