Table 1.
Patient characteristics (modified intention-to-treat analysis set)
| Characteristic | Trial part 1 | Trial part 2 | |||
| Group A (N=31) | Group B (N=29) | Group C (N=30) | Group B (N=20) | Group C (N=13) | |
| Age at randomization, years* | 61.7 (24.2–72.7) | 55.9 (20.7–73) | 62.3 (46.4–74.5) | 62.7 (32.9–70.7) | 60.8 (43.2–72.6) |
| 18–64 years | 21 (67.7) | 23 (79.3) | 21 (70.0) | 14 (70.0) | 11 (84.6) |
| 65–84 years | 10 (32.3) | 6 (20.7) | 9 (30.0) | 6 (30.0) | 2 (15.4) |
| BMI, kg/m2† | 24.7 (20.8–42.7) | 26.3 (16.3–39.7) | 25 (19.7–37.5) | 25.1 (19.9–37.7) | 24.8 (18.8–31.6) |
| Type of EOC | |||||
| Endometrioid | 2 (6.5) | 6 (20.7) | 1 (3.3) | – | – |
| Mucinous | 1 (3.2) | – | – | – | – |
| Serous | 28 (90.3) | 23 (79.3) | 29 (96.7) | 20 (100.0) | 13 (100.0) |
| Time since diagnosis, days* | 22 (14–105) | 28 (9–95) | 21.5 (12–113) | 34 (16–145) | 30 (15–40) |
| Time since primary debulking surgery, days* | 22 (13–35) | 22 (9–43) | 21.5 (12–39) | 31 (14–42) | 29 (15–40) |
| Post surgery residual lesion, n | 31 | 29 | 30 | 20 | 13 |
| Residuum <1 cm | 4 (12.9) | 5 (17.2) | 5 (16.7) | 1 (5.0) | 2 (15.4) |
| Zero residuum | 27 (87.1) | 24 (82.8) | 25 (83.3) | 19 (95.0) | 11 (84.6) |
| BRCA1 status,‡ n | 16 | 12 | 12 | 10 | 8 |
| Negative | 11 (68.8) | 8 (66.7) | 7 (58.3) | 8 (80.0) | 6 (75.0) |
| Not available | – | – | – | 1 (10.0) | – |
| Positive | 5 (31.3) | 4 (33.3) | 5 (41.7) | 1 (10.0) | 2 (25.0) |
| BRCA2 status,‡ n | 15 | 10 | 12 | 10 | 7 |
| Negative | 14 (93.3) | 9 (90.0) | 9 (75.0) | 9 (90.0) | 5 (71.4) |
| Not available | – | – | 1 (8.3) | 1 (10.0) | – |
| Positive | 1 (6.7) | 1 (10.0) | 2 (16.7) | – | 2 (28.6) |
| Tumor CD8+ cell count,† n | 29 | 23 | 26 | 18 | 13 |
| Cells/mm2 | 40.4 (0.5–615.1) | 110.5 (2.4–1092.4) | 85.5 (1.9–376.9) | 110.0 (20.2–494.7) | 72.5 (2.3–600.1) |
Values are median (range) or n (%).
*At randomization.
†At screening.
‡Assessment of BRCA status was not mandated in the protocol.
BMI, body mass index; EOC, epithelial ovarian cancer; Group A, DCVAC/OvCa in parallel with CT; Group B, CT and sequential DCVAC/OvCa; Group C, CT only.