Table 6.
Clinical trials evaluating emerging agents for the treatment of patients with advanced ovarian cancer
| Clinical Trial | Treatment | Patient Populationa | Phase | Primary EP |
|---|---|---|---|---|
| Targeting folate receptor α (FRα) | ||||
| FORWARD I (NCT02631876) | Mirvetuximab soravtansine vs CT of choice (paclitaxel, pegylated liposomal doxorubicin or topotecan) | Platinum-resistant, FRα-positive OvCa | Randomized, open-label phase III | PFS |
| MIRASOL (NCT04209855) | Mirvetuximab soravtansine vs CT of choice (paclitaxel, pegylated liposomal doxorubicin, or topotecan) | Platinum-resistant OvCa with high FRα expression | Randomized, open-label phase III | PFS |
| SORAYA (NCT04296890) | Mirvetuximab soravtansine | Platinum-resistant OvCa with high FRα expression | Single-arm, open-label phase III | ORR |
| KEYNOTE PN409/FORWARD II (NCT02606305) | Mirvetuximab soravtansine + carboplatin or bev or pegylated liposomal doxorubicin or pembrolizumab or carboplatin/bev | FRα-positive OvCa | Phase Ib-II | ORR |
| NCT03552471 | Mirvetuximab soravtansine + rucaparib | FRα-positive, recurrent BRCA-mutated or platinum-resistant OvCa | Phase I | RP2D |
| NCT04300556 | Morab-202 | FRα-positive, platinum-resistant OvCa and other solid tumors | Phase I–II | Safety, RP2D, ORR |
| Tissue factor (TF) targeting | ||||
| NCT02552121 | Tisotumab vedotin | Relapsed/metastatic tumors known to express TF | Phase I–II | Safety, RP2D |
| InnovaTV 208 (NCT03657043) | Tisotumab vedotin (standard or dose-dense regimen) | Platinum-resistant OvCa | Randomized, open-label phase II | ORR |
| Protein kinase inhibition | ||||
| NCT03579316 | Adavosertib single agent or + olaparib | Recurrent OvCa with progression after prior PARPi therapy | Randomized, open-label phase II | ORR |
| NCI MATCH screening trial/subprotocol Z1I BRCA-mutated tumors (NCT02465060) | Single-agent adavosertib | Advanced, BRCA-mutated, refractory OvCa | Phase II | ORR |
| NCT01623349 | Alpelisib (BYL 719) or buparlisib (BKM120) + olaparib | Recurrent high-grade OvCa after prior platinum-based therapy | Phase Ib | MTD, RP2D |
| NCT01663857 | Ralimetinib + CT (gemcitabine and carboplatin) vs CT | Recurrent OvCa, TFIp >6 months | Randomized, double-blind, phase Ib-II | PFS |
| NCT02203513 | Prexasertib (LY2606368) | Recurrent BRCA-mutated and BRCA-non mutated OvCa | Phase II | ORR |
| NCT03414047 | Prexasertib (LY2606368) | Recurrent, BRCA-mutated and BRCA-non mutated, platinum resistant/refractory OvCa | Phase II | ORR |
| CAPRI (NCT03462342) | AZD6738 + olaparib | Recurrent platinum-sensitive and platinum-resistant OvCa | Phase II | Safety |
| NCT02595892 | Berzosertib (M6620) + gemcitabine vs gemcitabine | Recurrent, platinum-resistant OvCa | Randomized, open-label phase II | PFS |
| NCT02627443 | Berzosertib (M6620) + carboplatin and gemcitabine | Recurrent, platinum-sensitive OvCa | Phase I | MTD, safety |
aClinical trials may include patients with other tumor types in addition to advanced ovarian cancer. AE: adverse event, Bev: bevacizumab, CT: chemotherapy, DLT: dose-limiting toxicity, EP: endpoint, MTD: maximum tolerated dose, ORR: objective response rate, OvCa: ovarian cancer, PARPi: PARP inhibitor, PFS: progression-free survival, q2 weeks: every 2 weeks, q3 weeks: every 3 weeks, RP2D: recommended phase II dose, SOC: standard of care, TFIp: platinum treatment-free interval.