Table 4:
Ongoing clinical trials in locally advanced or metastatic nccRCC
| Clinical trial | Phase | Experimental Arm | Control Arm | Cohort (Line of therapy) |
Primary Endpoint(s) |
|---|---|---|---|---|---|
|
PAPMET, SWOG S1500 NCT02761057 |
II | Cabozantinib Crizotinib Savolitinib Sunitinib |
N/A | pRCC (1st/2nd) | PFS |
| NCT02019693 | II | Capmatinib | N/A | pRCC (1st/2nd/3rd) | ORR |
| NCT01130519 | II | Bevacizumab+Erlotinib | N/A | pRCC (1st/2nd/3rd) HLRCC (1st/2nd/3rd) |
ORR |
| NCT02495103 | I/II | Vandetanib+Metformin | N/A | HLRCC SDH-associated pRCC |
ORR |
|
CABOSUN 2 NCT03541902 |
II | Cabozantinib | Sunitinib | Non-clear cell (1st/2nd) | PFS |
|
BONSAI NCT03354884 |
II | Cabozantinib | N/A | Collecting duct | ORR |
| NCT02915783 | II | Lenvatinib+Everolimus | N/A | Non-clear cell (1st) | ORR |
|
CYTOSHRINK NCT04090710 |
II | Ipilimumab+Nivolumab+SBRT | Ipilimumab+Nivolumab | Clear cell (1st) Non-clear cell (1st) |
PFS |
|
SUNIFORECAST NCT03075423 |
II | Ipilimumab+Nivolumab | Sunitinib | Non-clear cell (1st) | OS at 1 year |
|
CA209-9KU NCT03635892 |
II | Nivolumab+Cabozantinib | N/A | Non-clear cell (1st/2nd) | ORR |
| NCT03170960 | I/II | Atezolizumab+Cabozantinib | N/A | Clear cell (1st) Non-clear cell (2nd) |
MTD ORR |
|
ANZUP1602, UNISoN NCT03177239 |
II | Nivolumab (1st) followed by Ipilimumab+Nivolumab (2nd) | N/A | Non-clear cell (1st/2nd) | ORR |
|
CheckMate-920 NCT02982954 |
IIIb/IV | Ipilimumab+Nivolumab | N/A | Clear cell (1st) Non-clear cell (1st) |
IMAE |
|
KEYNOTE 427 NCT02853344 |
II | Pembrolizumab | N/A | Clear cell (1st) Non-clear cell (1st) |
ORR |
|
CheckMate 374 NCT02596035 |
IIIb/IV | Nivolumab | N/A | Clear cell (1st/2nd/3rd) Non-clear cell (1st/2nd/3rd) |
IMAE |
|
OMNIVORE NCT03203473 |
II | Ipilimumab+Nivolumab | N/A | Clear cell Non-clear celll |
PR/CR at 1 year after discontinuing nivolumab PR/CR at 1 year after adding ipilmumab |
|
AREN1721 NCT03595124 |
II | Axitinib+Nivolumab | Axitinib only Nivolumab only |
Translocation RCC | PFS |
|
PROSPER RCC NCT03055013 |
III | Perioperative Nivolumab and Nephrectomy | Nephrectomy alone | Biopsy proven RCC ≥T2Nx or TanyN+ or M1* |
EFS |
*
M1 disease has to be resected/definitively treated at the same time or within 12-weeks of surgery such that patient is considered “No Evidence of Disease”
DLT: dose-limiting toxicity; RCC: renal cell carcinoma; ccRCC: clear cell RCC; pRCC: papillary RCC; HLRCC: hereditary leiomyomatosis and RCC; PFS: progression-free survival; OS: overall survival; ORR: overall response rate; MTD: maximum tolerated dose; IMAE: incidence of high-grade immune-mediated adverse events; EFS: event-free survival; PR: partial response; CR: complete response; N/A: not applicable