TABLE 2.
Clinical Activity by Treatment and Tumor Type
| Treatment/Tumor Type | No.a | CR, No. (%) (95% CI) |
PR, No. (%) (95% CI) |
SD, No. (%) (95% CI) |
PD, No. (%) (95% CI) |
ORR CR+ PR, No. (%) (95% CI) |
CR + PR + SD Disease Control, No. (%) (95% CI) |
No. | Median OS (months) (95% CI) |
Median PFS (months) (95% CI) |
12-Month OS (%) (95% CI) |
Median DoR (months) (95% CI) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All | 108 | 12 (11.1) (5.9 to 18.6) |
29 (26.9) (18.8 to 36.2) |
47 (43.5) (34.0 to 53.4) |
20 (18.5) (11.7 to 27.1) |
41 (38.0) (28.8 to 47.8) |
88 (81.5) (72.9 to 88.3) |
120 | 15.5 (11.6 to 23.9) | 5.5 (4.5 to 9.8) | 56.7 (47.3 to 65.0) | 20.2 (14.4 to NE) |
| CaboNivo | 59 | 9 (15.3) (7.2 to 27.0) |
17 (28.8) (17.8 to 42.1) |
24 (40.7) (28.1 to 54.3) |
9 (15.3) (7.2 to 27.0) |
26 (44.1) (31.2 to 57.0) |
50 (84.7) (73.0 to 92.8) |
64 | 24.4 (14.0 to 36.8) | 11.0 (5.5 to 18.4) | 68.8 (55.9 to 78.6) | 25.8 (14.7 to NE) |
| CaboNivoIpi | 49 | 3 (6.1) (1.3 to 16.9) |
12 (24.5) (13.3 to 38.9) |
23 (46.9) (32.5 to 61.7) |
11 (22.5) (11.8 to 36.6) |
15 (30.6) (18.3 to 45.4) |
38 (77.6) (63.4 to 88.2) |
56 | 9.3 (5.8 to 15.9) | 4.5 (3.1 to 5.8) | 42.9 (29.8 to 55.3) | 14.5 (3.6 to 21.6) |
| Cabozantinib 40 mg daily/Nivo ± Ipib | 91 | 10 (11.0) (5.4 to 19.3) |
25 (27.5) (18.6 to 37.8) |
38 (41.8) (31.5 to 52.6) |
18 (19.8) (12.2 to 29.5) |
35 (38.5) (28.5 to 49.3) |
73 (80.2) (70.6 to 87.8) |
102 | 15.8 (9.9 to 23.9) | 5.5 (3.9 to 10.1) | 57.8 (47.7 to 66.7) | 20.2 (14.5 to NE) |
| Cabozantinib 60 mg daily/Nivo ± Ipic | 17 | 2 (11.8) (1.5 to 36.4) |
4 (23.5) (6.8 to 49.9) |
9 (52.9) (27.8 to 77.0) |
2 (11.8) (1.5 to 36.4) |
6 (35.3) (14.2 to 61.7) |
15 (88.2) (63.6 to 98.5) |
18 | 12.9 (10.0 to 26.0) | 6.7 (4.7 to 12.8) | 50.0 (25.9 to 70.1) | 14.8 (2.4 to NE) |
| Tumor type | ||||||||||||
| Urothelial carcinoma | 33 | 7 (21.2) (9.0 to 38.9) |
7 (21.2) (9.0 to 38.9) |
12 (36.4) (20.4 to 54.9) |
7 (21.2) (9.0 to 38.9) |
14 (42.4) (25.5 to 60.8) |
26 (78.8) (61.1 to 91.0) |
39 | 24.9 (11.8 to 41.6) | 10.1 (2.2 to 21.2) | 66.7 (49.6 to 79.1) | 28.0 (11.5 to NE) |
| Clear cell RCC | 16 | 2 (12.5) (1.6 to 38.4) |
8 (50.0) (24.7 to 75.4) |
6 (37.5) (15.2 to 64.6) |
0 | 10 (62.5) (35.4 to 84.8) |
16 (100) (79.4 to 100) |
16 | 43.6 (19.4 to NE) | 16.3 (6.4 to 21.8) | 81.3 (52.5 to 93.5) | 16.7 (3.6 to NE) |
| Penile carcinoma | 9 | 0 | 4 (44.4) (13.7 to 78.8) |
5 (55.6) (21.2 to 86.3) |
0 | 4 (44.4) (13.7 to 78.8) |
9 (100) (66.4 to 100) |
11 | 6.7 (5.2 to 23.9) | 4.8 (3.1 to 6.4) | 36.4 (11.2 to 62.7) | 9.2 (2.4 to NE) |
| Prostate adenocarcinoma | 9 | 0 | 1 (11.1) (0.3 to 48.3) |
7 (77.8) (40.0 to 97.2) |
1 (11.1) (0.3 to 48.3) |
1 (11.1) (0.3 to 48.3) |
8 (88.9) (51.8 to 99.7) |
10 | 11.1 (6.6 to 17.0) | 4.5 (1.6 to 5.1) | 40.0 (12.3 to 67.0) | 3.7 |
| Adenocarcinoma bladder | 15 | 1 (6.7) (0.2 to 32.0) |
2 (13.3) (1.7 to 40.5) |
9 (60.0) (32.3 to 83.7) |
3 (20.0) (4.3 to 48.1) |
3 (20.0) (4.3 to 48.1) |
12 (80) (51.9 to 95.7) |
15 | 18.0 (5.8 to 28.2) | 10.1 (1.8 to 16.5) | 80.0 (50.0 to 93.1) | 14.7 (11.0 to NE) |
| Squamous cell carcinoma bladder | 7 | 2 (28.6) (3.7 to 71.0) |
4 (57.1) (18.4 to 90.1) |
1 (14.3) (0.4 to 57.9) |
0 | 6 (85.7) (42.1 to 99.6) |
7 (100) (59.0 to 100) |
8 | 22.6 (1.4 to NE) | 16.5 (1.4 to NE) | 62.5 (22.9 to 86.1) | 25.8 (1.6 to NE) |
| Germ cell tumor | 6 | 0 | 0 | 1 (16.7) (0.4 to 64.1) |
5 (83.3) (35.9 to 99.6) |
0 | 1 (16.7) (0.4 to 64.1) |
|||||
| Small cell carcinoma of bladder/renal pelvis | 3 | 0 | 1 (33.3) (0.8 to 90.6) |
0 | 2 (66.7) (9.4 to 99.2) |
1 (33.3) (0.8 to 90.6) |
1 (33.3) (0.8 to 90.6) |
|||||
| Renal medullary carcinoma | 2 | 0 | 1 (50.0) | 0 | 1 (50.0) | 1 (50.0) | 1 (50.0) | |||||
| Testicular primitive neuroectodermal tumor | 2 | 0 | 0 | 1 (50.0) | 1 (50.0) | 0 | 1 (50.0) | |||||
| Trophoblastic tumor | 1 | 0 | 0 | 1 (100) | 0 | 0 | 1 (100) | |||||
| Sertoli cell tumor | 1 | 0 | 0 | 1 (100) | 0 | 0 | 1 (100) | |||||
| Collecting duct carcinoma | 1 | 0 | 0 | 1 (100) | 0 | 0 | 1 (100) | |||||
| Chromophobe RCC | 1 | 0 | 1 (100) | 0 | 0 | 1 (100) | 1 (100) | |||||
| Papillary RCC | 1 | 0 | 0 | 1 (100) | 0 | 0 | 1 (100) | |||||
| Sarcomatoid bladder | 1 | 0 | 0 | 1 (100) | 0 | 0 | 1 (100) |
Abbreviations: CR, complete response; DoR, duration of response; NE, not estimable; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; RCC, renal cell carcinoma; SD, stable disease.
a
Number evaluable for response.
b
Includes patients receiving varying doses of nivo +/− ipi in the dose escalation and expansion cohorts, see Appendix Fig A1B.
c
Includes patients receiving varying doses of nivo +/− ipi in the dose escalation cohorts, see Appendix Fig A1B.