Table 1.
Major clinical trials designed for all nccRCC histotypes.
| Trial name | Phase | Patients | Study arms | Outcomes |
|---|---|---|---|---|
| Completed trials | ||||
| NCT01219751 18 | II | 31 advanced nccRCC-naïve patients | Single arm: sunitinib | ORR: 35%, CR: 0%, mPFS 6.4 mts, mOS: NR (estimated 25.6 mts) |
|
NCT01108445 “ASPEN” 6 |
II | 108 advanced nccRCC-naïve patients | Randomized: sunitinib vs everolimus | ORR: 18% vs 9%, CR: 0% vs 4%, mPFS 6.1 mts vs 4.1 mts, mOS: 16.2 mts vs 14.9 mts |
|
NCT01185366 “ESPN” 7 |
II | 70 advanced nccRCC-naïve patients | Randomized: sunitinib vs everolimus | ORR: 9% vs 3%, CR: 0% vs 0%, mPFS 8.3 mts vs 5.6 mts, mOS: 31.5 mts vs 13.2 mts |
|
NCT00979966 “CESAR” 19 |
IIa | 22 advanced nccRCC-naïve patients | Randomized: sunitinib vs temsirolimus | ORR: 3% vs 2%, CR: 0% vs 0%, mPFS 13.2 mts vs 9.3 mts, mOS: 19.8 mts vs 19.4 mts |
| NCT01538238 20 | II | 29 advanced nccRCC-naïve patients | Single arm: pazopanib | ORR: 29%, CR: 0%, mPFS 16.5 mts, mOS: NR |
| NCT01798446 21 | II | 40 advanced nccRCC patients in progression after temsirolimus | Single arm: axitinib | ORR: 37.5%, CR: 0%, mPFS 7.4 mts, mOS: 12.1 mts |
| NCT01399918 22 | II | 37 advanced nccRCC-naïve patients | Single arm: everolimus + bevacizumab | ORR: 35%, CR: 0%, mPFS 13.7 mts, mOS: 35.9 mts |
| NCT02915783 23 | II | 31 advanced nccRCC-naïve patients | Single arm: everolimus + lenvatinib | ORR: 26%, CR: 0%, mPFS 9.2 mts, mOS: 15.6 mts |
|
NCT02596035 “CheckMate-374” 24 |
IIIb/IV | 44 advanced nccRCC-naïve or pretreated (⩽1 line) patients | Single arm: nivolumab | ORR: 13.6%, CR: 2.3% mPFS 2.2 mts, mOS: 16.3 mts |
|
NCT02853344 “KEYNOTE-427 cohort B” 25 |
II | 165 advanced nccRCC-naïve patients | Single arm: pembrolizumab | ORR: 26.7%, CR: 6.7%, mPFS: 4.2 mts, mOS: 28.9 mts |
| NCT02724878 26 | II | 42 advanced nccRCC-naïve or pretreated (⩽1 line) patients | Single arm: atezolizumab + bevacizumab | ORR: 26%, CR: 0%, mPFS: 8.3 mts, mOS: NR |
| NCT03170960 27 | Ib/II | 32 advanced nccRCC-naïve or pretreated (⩽1 line) patients | Single arm: atezolizumab + cabozantinib | ORR: 31%, CR: 0%, mPFS: 9.5 mts, mOS: NR |
|
NCT03117309 “HCRN GU16-260-Cohort B” 9 |
II | 35 advanced nccRCC-naïve patients | Single arm: nivolumab → nivolumab + ipilimumab | ORR : 14.3%, CR: 5.7%, mPFS: 4.0 mts, mOS: NR |
|
NCT02982954 “ChekMate-920” 10 |
IIIb/IV | 52 advanced nccRCC-naïve patients | Single arm: nivolumab + ipilimumab | ORR: 19.6%, CR: 4.3%, mPFS: 3.7 mts, mOS: 21.2 mts |
|
NCT03635892 “CA209-9KU“11,12 |
II | 47 advanced nccRCC-naïve or pretreated (⩽1 line) patients | Single arm: nivolumab + cabozantinib | ORR: 48%, CR: 4%, mPFS: 12.5 mts, mOS: 28.0 mts |
|
NCT04704219 “KEYNOTE-B61“ 13 |
II | 158 advanced nccRCC-naïve patients | Single arm: pembrolizumab + lenvatinib | ORR: 49%, CR: 6%, mPFS: 18 mts, mOS: NR |
| NCT05220267 29 | II | 43 advanced nccRCC-naïve patients | Single arm: anlotinib + sintilimab | ORR: 52.9%, mPFS: 15.1 mts, mOS: NR |
|
NCT03075423 “SUNNIFORECAST” 30 |
II | 309 advanced nccRCC-naïve patients | Randomized: nivolumab + ipilimumab vs standard of care | ORR: 32.8% vs 19.6%, mPFS: 5.52 mts vs 5.65 mts, mOS: 42.4 mts vs 33.9 mts |
| Ongoing trials | ||||
| NCT03866382 28 | II | 224 advanced rare genitourinary cancer-naïve or pretreated (⩽2 line) patients | Single arm: nivolumab + ipilimumab + cabozantinib | Estimated completion: 2025 |
| NCT04413123 31 | II | 60 advanced nccRCC-naïve or pretreated (⩽1 line) patients | Single arm: nivolumab + ipilimumab + cabozantinib | Estimated completion: 2025 |
|
NCT04267120 “LENKYN trial” 32 |
II | 34 advanced nccRCC-naïve patients | Single arm: pembrolizumab + lenvatinib | Estimated completion: 2027 |
|
NCT05678673 “STELLAR-304” 33 |
III | 291 advanced nccRCC-naïve patients | Zanzalintinib + nivolumab vs sunitinib | Estimated completion: 2028 |
|
NCT03595124 “AREN1721” 34 |
II | 40 advanced translocation RCC-naïve or pretreated (⩽1 line) patients | Randomized: nivolumab + axitinib vs nivolumab | Estimated completion: 2031 |
Data were acquired from clinicaltrial.gov (accessed on September 22nd, 2024).
CR, complete response; mts, months, mOS, median overall survival; mPFS, median progression-free survival; NR, not reached; ORR, objective response rate.