Table 3.
Ongoing phase III trials on combination maintenance therapy in frontline settings
| Trial | Trial design | ClinicalTrials.gov identifier | No of patients | Patient population | Treatment arms | Primary end point | Estimated study completion date |
|---|---|---|---|---|---|---|---|
| IMagyn050/GOG 3015/ENGOT-OV39 | 2-arm, phase III, randomised trial | NCT03038100 | 1300 | Newly diagnosed stage III/IV OC |
1. CT + BEV + atezolizumab ➔ BEV + atezolizumab 2. CT + BEV + placebo ➔ BEV + placebo |
PFS and OS (ITT and PD-L1+ populations) | December 2022 |
| ATHENA/GOG-3020/ENGOT-OV45 | 4-arm, phase III, randomised maintenance trial | NCT03522246 | 1012 | Newly diagnosed stage III/IV EOC in response after completing CRS (PDS or IDS) and first-line platinum-based chemotherapy |
1. Rucaparib + nivolumab 2. Rucaparib + placebo 3. Placebo + nivolumab 4. Placebo + placebo |
Investigator-assessed PFS | December 2024 |
| DUO-O/AGO-OVAR23/ENGOT-OV46 | 2-cohort, phase III, randomised trial: double-blind 3-arm trial in non-BRCA-mutated and single open-label cohort in BRCA-mutated | NCT03737643 | 1374 | Newly diagnosed stage III/IV OC, candidate for CRS (PDS or IDS), bevacizumab eligible |
1. CT + BEV + placebo ➔ BEV + placebo + placebo 2. CT + BEV + durvalumab ➔ + BEV + durvalumab + placebo 3. CT + BEV + durvalumab ➔ BEV + durvalumab + olaparib 4. Tumour BRCA-mutated cohort: CP + BEV (optional) + durvalumab ➔ BEV (optional) + durvalumab + olaparib |
PFS in non-tBRCA HRD positive and all non-tBRCA patients patients | June 2023 |
| ENGOT-OV43/GOG-3036/KEYLYNK-001 | 3-arm randomised trial | NCT03740165 | 1086 | Newly diagnosed non-BRCA-mutated stage III/IV EOC having undergone PDS or eligible for PDS or IDS, candidate for CP |
1. CT + pembrolizumab ➔ pembrolizumab + olaparib 2. CT + pembrolizumab ➔ pembrolizumab + placebo (optional BEV) 3. CT+ placebo ➔ placebo + placebo (optional BEV) |
Investigator-assessed PFS and OS | October 2023 |
| FIRST/ENGOT-OV44 | 3-arm randomised trial | NCT03602859 | 912 | Newly diagnosed stage III/IV non-mucinous EOC |
1. CT + placebo ➔ placebo + placebo 2. CT + placebo ➔ niraparib + placebo 3. CT + dostarlimab ➔ niraparib + dostarlimab |
Investigator-assessed PFS | July 2023 |
| MAMOC | 2-arm randomised trial | NCT04227522 | 190 | Non-BRCA-mutated |
1. CT + BEV ➔ BEV ➔ rucaparib 2. CT + BEV ➔ BEV ➔ placebo |
PFS | January 2023 |
BRCA BReast CAncer gene, BEV Bevacizumab, CT Chemotherapy, CRS Cytoreductive surgery, EOC Epithelial ovarian cancer, IDS Interval debulking surgery, HRD Homologous recombination deficiency, ITT Intention-to-treat population, OS Overall survival, OC Ovarian cancer, PDS Primary debulking surgery, PFS Progression-free survival, PDL-1 Programmed death-ligand 1, tBRCA Tumour BReast CAncer gene