Table 4:
Select ongoing Phase II and III clinical trials of PARP inhibitors in patients with ovarian cancer
| Setting | Study Name | NCT number | Trial Phase | Treatment arms | Patient Population |
|---|---|---|---|---|---|
| Frontline | ATHENA | NCT03522246 | III | maintenance therapy with: - rucaparib/nivolumab - rucaparib/placebo - placebo/nivolumab - placebo/placebo |
newly diagnosed ovarian cancer patients with response to first line chemotherapy |
| DUO-O/ENGOT-ov46 | NCT03737643 | III | - platinum-based chemotherapy/bevacizumab/durvalumab followed by maintenance bevacizumab/durvalumab/olaparib - platinum-based chemotherapy/bevaciumab /durvalumab followed by maintenance bevacizumab/durvalumab/placebo - platinum-based chemotherapy/bevaciumab /placebo followed by maintenance bevacizumab/placebo/olap arib For BRCA cohort: - platinum-based chemotherapy/bevaciumab /durvalumab followed by maintenance bevacizumab/durvalumab/olpaarib (bevacizumab optional for this cohort) |
newly diagnosed Stage III-IV ovarian cancer who are candidate for surgery (upfront or interval) with known somatic BRCA status | |
| GOG-3036/EN GOT-ov43/KEY LYNK-001 | NCT03740165 | III | - carboplatin/paclitaxel/pem brolizumab followed by pembrolizumab/olaparib maintenance - carboplatin/paclitaxel/pem brolizumab followed by pembrolizumab/placebo maintenance - carboplatin/paclitaxel/place bo followed by placebo/placebo maintenance. NOTE: Bevacizumab treatment and maintenance is allowed in all groups |
newly diagnosed Stage III-IV ovarian cancer who are candidate for surgery (upfront or interval) without germline or somatic BRCA mutations | |
| FIRST (ENGOT-OV44) | NCT03602859 | III | - platinum-based chemotherapy/dostarlimab followed by maintenance dostarlimab/niraparib - platinum-based chemotherapy/placebo followed by maintenance placebo/niraparib - platinum-based chemotherapy/placebo followed by maintenance placebo/placebo |
newly diagnosed Stage III who are receiving neoadjuvant therapy or are high risk, or all stage IV ovarian cancer | |
| Recurrent | NRG-GY004 | NCT02446600 | III | - olaparib - olaparib/cediranib - cytotoxic chemotherapy (carboplatin/paclitaxel, carboplatin/gemcitabine, carboplatin/liposomal doxorubicin) |
platinum-sensitive recurrent ovarian cancer |
| ICON9 | NCT03278717 | III | - maintenance olaparib - maintenance olaparib/cediranib |
platinumsensitive recurrent ovarian cancer | |
| NCT02345265 | II | - olaparib - olaparib/cediranib |
platinum-sensitive or platinum-resistant recurrent ovarian cancer | ||
| NRG-GY005 | NCT02502266 | II/III | - cytotoxic chemo (weekly paclitaxel, liposomal doxorubicin, topotecan) cediranib/olaparib - cediranib - olaparib. NOTE: Phase III does not include the olaparib only arm. |
platinum-resistant or refractor recurrent ovarian cancer | |
| CONCERTO | NCT02889900 | IIB | cediranib/olaparib | platinum-resistant, recurrent ovarian cancer, BRCA wildtype | |
| NCT02345265 | II | cediranib/olaparib | platinumsensitive or resistant/ref ractory recurrent ovarian cancer | ||
| ANITA | NCT03598270 | III | - Atezolizumab/cytotoxic chemotherapy (carboplatin/paclitaxel, carboplatin/gemcitabine, carboplatin/liposomal doxorubicin) followed by atezolizumab/niraparib maintenance - Atezolizumab/cytotoxic chemotherapy (carboplatin/paclitaxel, carboplatin/gemcitabine, carboplatin/liposomal doxorubicin) followed by placebo/niraparib maintenance |
platinum-sensitive recurrent ovarian cancer with known BRCA mutation status | |
| ARIES | NCT03824704 | II | rucaparib/nivolumab | platinumsensitive recurrent ovarian cancer with either somatic BRCA mutatino or loss of heterozygosity | |
| ReTreatment | OREO | NCT03106987 | IIIB | - olaparib - placebo | platinum-sensitive recurrent ovarian cancer with known BRCA mutation status, previously treated with PARP inhibitor maintenance therapy |
| MOLTO | NCT02855697 | II (feasibi lity) | - maintenance olaparib for first maintenance - either olaparib or olaparib/cediranib for second maintenance |
platinum-sensitive recurrent ovarian cancer (with and without prior PARP inhibitor maintenanc e), with germline BRCA mutations |
1. Gonzalez-Martin, A., et al., Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med, 2019. 381(25): p. 2391–2402.
2. Ray-Coquard, I., et al., Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer. N Engl J Med, 2019. 381(25): p. 2416–2428.
3. Coleman, R.L., et al., Veliparib with First-Line Chemotherapy and as Maintenance Therapy in Ovarian Cancer. N Engl J Med, 2019. 381(25): p. 2403–2415.