Table 3.
Notable clinical trials with published results for chromophobe RCC
| Trial | Enrollment criteria | Number with chromophobe RCC | Intervention | Results |
|---|---|---|---|---|
|
| ||||
| Single-agent ICI | ||||
| NCT02853344 (Keynote-427)96 | No prior systemic therapy | 21 (12.7%) | Pembrolizumab | ORR: 9.5% (95% CI 1.2–30.4) Median PFS: 3.9 m (95% CI 2.6–6.9) Median OS: 23.5 m (95% CI 9.3–NR) |
| NCT03117309 (HCRN GU16-260)93 | No prior systemic therapy | 6 (17%) | Nivolumab (part A), then with ipilimumab if refractory to monotherapy (part B) | ORR: 1/6 (17%) |
| NCT02596035 (CheckMate 374)94 | Prior systemic therapy allowed | 7 (15.9%) | Nivolumab | ORR: 28.6% |
| NCT03012581 (AcSe)95 | 9 (18%) | Nivolumab | ORR: 0 | |
|
| ||||
| Single-agent mTOR inhibitor/TKI | ||||
| NCT01185366 (ESPN)107 | No prior systemic therapy | Everolimus: 6 (17%) Sun: 6 (18%) |
Everolimus vs. sunitinib | ORR: Everolimus: 1 (3%) Sun: 2 (6%) Median PFS: Everolimus: NA Sun: 8.9 m (95% CI 2.9–20.1) Median OS: Everolimus: 25.1 (95% CI 4.7–NA) Sun: 31.6 m (95% CI 14.2–NA) |
|
| ||||
| Combination TKI and mTOR inhibitor | ||||
| NCT01108445 (ASPEN)101 | No prior systemic treatment | Everolimus: 6 (10%) Sun: 10 (20%) |
Everolimus plus lenvatinib vs. sunitinib | ORR: Everolimus: 2 (33%) Sun: 1 (10%) |
| NCT02915783105 | No prior systemic treatment | 9 (29%) | Lenvatinib plus everolimus | ORR: 44% Median PFS: 13.1 m (95% CI 0.5–NE) Median OS: NE m (95% CI 0.5–NE) |
|
| ||||
| Combination ICI | ||||
| NCT02982954 CheckMate 920102 | No prior systemic therapy | 7 (13.5%) | Nivolumab with ipilimumab | ORR: 0% |
| NCT03075423 SUNNIFORECAST104 | No prior systemic therapy | 60 (19.4%) | Nivolumab with ipilimumab | ORR: 25.9% |
|
| ||||
| Combination ICI and TKI | ||||
| NCT03635892 (CA209-9KU)108 | No prior ICIs | 7 | Cabozantinib with nivolumab | ORR: 0% |
| NCT04704219 (Keynote-B61)98 | No prior therapy | 29 (18%) | Pembrolizumab plus lenvatinib | ORR: 28% (95% CI 13–47) Median PFS: 12.5 m (3.9–NR) |
| NCT03170960 (COSMIC-021)99 | No prior ICIs or MET inhibitors | 8 (25%) | Atezolizumab with cabozantinib | ORR: 11% |
|
| ||||
| Combination ICI and anti-angiogenic | ||||
| NCT02724878106 | Prior systemic therapy Allowed but not ICI or bevacizumab | 10 (29%) | Atezolizumab with bevacizumab | ORR: 10% |
CI: confidence interval; HR: hazard ratio; ICI: immune checkpoint inhibitors; NA: not available; NE: not evaluable; NR: not reported; ORR: objective response rate; OS: overall survival; PFS: progression-free survival; RCC: renal cell carcinoma; TKI: tyrosine kinase inhibitor; VGEF: vascular endothelial growth factor.