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Table 4 An overview of phase III clinical trials in RCC

From: Determinants of resistance to VEGF-TKI and immune checkpoint inhibitors in metastatic renal cell carcinoma

NCT name Arm Primary endpoint Results
NCT00903175
RECORD 3
First-line Everolimus followed by second line sunitinib
vs
First line sunitinib followed by second line everolimus
PFS Median PFS 21.7 months (mo.) (95%CI: 15.1–26.7) vs 22 mo. (95%CI16–29.8). Median OS: 22.4 mo. (95%CI 18.6–33.3 Vs 29.5 mo. (95% CI:22.8–33.1)
NCT00720941
COMPARZ
Control arm: Sunitinib
Experimental arm: Pazopanib
PFS HR: 1.05 95% CI: 0.90 to 1.22
OS: HR: 0.91,95% CI: 0.76–1.08
NCT00073307
TARGET
Experimental arm: Sorafenib
Placebo comparator: Placebo
OS Median PFS: 5.5mo. vs 2.8mo. HR 0.44 95% CI 0.35–0.55 p < 0.01. First interim analysis of OS: sorafenib reduced the risk of death (HR: 0.72; 95%CI, 0.54–0.95 P = 0.02)
NCT02231749
CheckMate 214
Experimental arm: Nivolumab + Ipilumab
Active comparator: Sunitinib
ORR, OS, PFS 18 month OS: 75% (95%CI-70 to 78) vs 60% (95%CI: 55–65); ORR: 42% vs 27%, median PFS 11.6mo. vs 8.4 mo.
NCT01835158
Cabosun
Arm 1: Cabozantinib
Arm 2: Sunitinib
PFS, OS Median PFS 8.2 vs 5.6 mo. adjusted HR, 0.66; 95% CI, 0.46 to 0.95 P = 0.012 ORR 33% vs 12%
NCT02684006
Javelin Renal 101
Experimental: Avelumab plus axitinib
Active comparator: Sunitinib
PFS, OS Median PFS 13.8mo vs. 7.2 mo.HR 0.61 95% confidence interval [CI], 0.47 to 0.79; P < 0.001, ORR 55.2% vs. 25.5%
NCT02853331
KEYNOTE426
Experimental: Pembrolizumab + Axitinib
Active comparator: Sunitinib
PFS, OS Median PFS: 15.1 mo. vs. 11.1mo. HR: 0.69; 95% CI, 0.57 to 0.84; P < 0.001 ORR: 59.3% (95% CI, 54.5 to 63.9) vs. 35.7% (95% CI, 31.1 to 40.4)
  1. PFS Progression-free survival, OS Overall survival, HR Hazard ratio, ORR Overall response rate