Table 3. Clinical trial data related to ICI and ICI combined with other drugs in the treatment of RCC.
| Susbstances | n | Patients | Results | Adverse events | References | ||
|---|---|---|---|---|---|---|---|
| Nivolumab vs. everolimus phase 3 |
410 vs. 411 | Treated,advanced renal cell carcinoma, Karnofsky performance status of ≥70% | PFS(median): 4.6 months vs. 4.4 months (p = 0.11) |
OS (median): 25.0 months vs. 19.6 months |
ORR(median): 25% vs. 5% (p < 0.001) |
Grade 3 or 4: 19% vs. 37% | [60] |
| KEYNOTE-564 pembrolizumab vs. placebo phase 3 |
496 vs. 498 | post-nephrectomy,clear cell renal cell carcinoma, no systemic treatment | The disease-free survival rate of pembrolizumab was better than that of placebo (HR 0.63 [95% CI 0.50–0.80]); Estimated proportion of medium survival without recurrence: 75.2% vs. 65.5%; Overall survival was better with pembrolizumab compared with placebo (HR 0.52 [nominal 95% CI 0.31–0.86]). Estimated proportion of surviving participants: 95.7% vs. 91.4% |
Treatment induced serious adverse events: 59 (12%) vs. 1 (<1%) | [61,62] | ||
| Atezolizumab vs. placebo phase 3 |
390 vs. 388 | Nephrectomy with or without metastasis,CCRCC or RCC with sarcomatoid component | Median investigator-assessed disease-free survival: 57.2 months (95% CI 44.6 to not evaluable) vs. 49.5 months (47.4 to not evaluable; hazard ratio 0.93, 95% CI 0.75–1.15, p = 0.50) | Grade 3 or 4: hypertension (7 [2%] vs. 15 [4%]), hyperglycaemia (10 [3%] vs. 6 [2%]), and diarrhoea (2 [1%] vs. 7 [2%]) | [63,64] | ||
| Nivolumab with cabozantinib vs. sunitinib phase 3 |
323 vs. 328 | Untreated, advanced renal cell carcinoma with clear cell composition,Karnofsky performance status of ≥70% | PFS(median): 16.6 months vs. 8.3 months (p < 0.001) |
OS (median): 18.1 months The probability of overall survival at 12 months was 85.7% vs. 75.6% (p = 0.001) |
ORR(median): 55.7% vs. 27.1% (p < 0.001) |
Grade 3 or 4: 75.3% vs. 70.6% | [65,66] |
| KEYNOTE-426 pembrolizumab + axitinib vs. sunitinib phase 3 |
432 vs. 429 | Treatment-naive,advanced renal cell carcinoma with clear cell composition | PFS(median): 15.4 months vs. 11.1 months (p < 0.0001) |
OS (median): not reached vs. 35·7 months (p = 0.0003) |
ORR(median): 60.0% vs. 40.0% (p < 0.0001) |
Grade 3 or 4: Hypertension (95 [22%] vs. 84 [20%]), elevated alanine aminotransferase (54 [13%] vs. 11 [3%]) and diarrhea (46 [11%] vs. 23 [5%]) | [67] |
| Lenvatinib with pembrolizumab vs. lenvatinib + everolimus vs. sunitinib phase 3 |
355 vs. 357 vs. 357 | Untreated,advanced renal cell carcinoma, Karnofsky performance status of ≥70% | PFS(median): 23.9 months vs. 14.7 months vs. 9.2 months (p < 0.001) | OS (median): not reached with any treatment; alive at 24 months: 79.2% vs. 66.1% vs. 70.4% |
ORR(median): 71.0% vs. 53.5% vs. 36.1% complete response(CR): 16.1% vs. 9.8% vs. 4.2% |
All grades: 99.7% (lovatinib pebruzumab group and lovatinib everolimus group) vs. 98.5% (sunitinib group) Grade 3 or 4: 82.4% vs. 83.1% vs. 71.8% |
[68,69] |
| JAVELIN kidney 101 avelumab + axitinib vs. sunitinib phase 3 |
442 vs. 444 | Untreated, advanced renal cell carcinoma with clear cell composition, 830 patients, including approximately 580 patients with PD-L1–positive tumors (70%), Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 | PFS(median): 13.3 months vs. 8.0 months 13.8 months vs. 7.0 months (PD-L1–positive) (p < 0.0001) |
OS (median): Impossible to estimate (NE) vs. NE (p = 0.0329); NE vs. 28.6 months (PD-L1–positive) (p = 0.1301) |
ORR(median): 52.5% vs. 27.3%; 55.9% vs. 27.2% (PD-L1–positive) |
All grades: 99.5% vs. 99.3% Grade 3 or 4: 71.2% vs. 71.5% |
[70–73] |
| CheckMate 214 nivolumab + ipilimumab vs. sunitinib phase 3 |
550 vs. 446 | Untreated, advanced or metastatic renal cell carcinoma with clear cell composition, performance status of ≥70% | PFS (median): 12.3 months vs. 12.3 months) |
OS (median): 55.7 months vs. 38.4 months |
ORR(median): 39.3% vs. 32.4% |
Grade ≥3 immune-mediated adverse event experience, body mass index, and age | [74,75] |