Table 5.
Trial name | GOG3015/ENGOT OV39 | FIRST trial/ENGOT Ov-44 | DUO-O/ENGOT Ov-46 | ENGOT Ov-43/MK7339-001 | ATHENA |
---|---|---|---|---|---|
Trial identifier | NCT03038100 | NCT03602859 | NCT03737643 | NCT03740165 | NCT03522246 |
Histology | Epithelial | Epithelial | Epithelial | Epithelial | Epithelial |
FIGO stage | III–IV | III–IV | III–IV | III–IV | III–IV |
ECOG PS | 0–2 | 0–1 | 0–2 | 0–1 | 0–2 |
Investigational drugs | Atezolizumab |
Dorstarlimab Niraparib |
Durvalumab Olaparib |
Pembrolizumab Olaparib |
Nivolumab Rucaparib |
Control arm-chemotherapy phase |
IV paclitaxel + IV carboplatin + IV bevacizumab + IV atezolizumab placebo |
Arm 1: Standard of care chemotherapy + IV dorstarlimab placebo |
Arm 1: IV paclitaxel + IV carboplatin + IV bevacizumab + IV durvalumab placebo |
Arm 3: IV paclitaxel + IV carboplatin ± IV bevacizumab + IV pembrolizumab placebo |
N/A |
Control arm-maintenance phase |
IV bevacizumab + IV atezolizumab placebo |
Arm 1: IV dorstarlimab placebo + PO niraparib placebo |
Arm 1: IV bevacizumab + IV durvalumab placebo + PO olaparib placebo |
Arm 3: ± IV bevacizumab + IV pembrolizumab placebo + PO olaparib placebo |
Arm D: IV nivolumab placebo + PO rucaparib placebo |
Experimental arm (1)-chemotherapy phase |
IV paclitaxel + IV carboplatin + IV bevacizumab + IV atezolizumab (1200 mg, three-weekly) |
Arm 2: Standard of care chemotherapy + IV dorstarlimab placebo |
Arm 2: IV paclitaxel + IV carboplatin + IV bevacizumab + IV durvalumab |
Arm 1: IV paclitaxel + IV carboplatin ± IV bevacizumab + IV pembrolizumab (200 mg, three weekly) |
N/A |
Experimental arm (1)-maintenance phase |
IV bevacizumab + IV atezolizumab (1200 mg, three-weekly) |
Arm 2: IV dorstarlimab placebo + PO niraparib |
Arm 2: IV bevacizumab + IV durvalumab + PO olaparib placebo |
Arm 1: ± IV bevacizumab + IV pembrolizumab (200 mg, three-weekly) + PO olaparib (300 mg, twice-daily) |
Arm A: IV nivolumab (four-weekly) + PO rucaparib (twice-daily) |
Experimental arm (2)-chemotherapy phase | N/A |
Arm 3: Standard of care chemotherapy + IV dorstarlimab |
Arm 3/patients with tBRCAm: IV paclitaxel + IV carboplatin ± IV cevacizumab + IV durvalumab |
Arm 2: IV paclitaxel + IV carboplatin ± IV bevacizumab + IV pembrolizumab |
N/A |
Experimental Arm (2)-maintenance phase | N/A |
Arm 3: IV dorstarlimab + PO niraparib |
Arm 3/patients with tBRCAm: ± IV bevacizumab + IV durvalumab + PO olaparib |
Arm 2: ± IV bevacizumab + IV pembrolizumab (200 mg, three-weekly) + PO olaparib placebo |
Arm B: IV nivolumab placebo + PO rucaparib (twice-daily) |
Experimental arm (3)-maintenance phase | N/A | N/A | N/A | N/A |
Arm C: IV nivolumab (four-weekly) + PO rucaparib placebo |
Primary outcome |
PFS in intention to treat (ITT) population PFS in programmed cell death-ligand 1 (PD-L1)-positive subpopulation OS in ITT population OS in PD-L1-positive population |
PFS | PFS–in non-tBRCAm patients |
PFS OS |
PFS |