Table 2. Ongoing combination phase I-III clinical trials with immune checkpoint inhibitors in aRCC.
| Trial | Phase | Trial summary | Population | Trial status | Estimated study completion date |
|---|---|---|---|---|---|
| Checkmate 016 NCT01472081 [100,101] | I | Nivolumab + ipilimumab | Treated and untreated aRCC | Study ongoing; not recruiting | June 2018 |
| Nivolumab + sunitinib | |||||
| Nivolumab + pazopanib | |||||
| NCT02210117 [102] | Early phase I | Experimental arm A – nivolumab | Neoadjuvant pilot – mRCC (clear cell) who are eligible for cytoreductive nephrectomy, metastasectomy or post-treatment biopsy. Treated and untreated | Study currently recruiting | November 2019 |
| Experimental arm B – nivolumab + bevacizumab | |||||
| Experimental arm C – nivolumab + ipilimumab | |||||
| NCT02348008 [103] | I/II | Pembrolizumab + bevacizumab | In first- and second-line treatment for aRCC (clear cell) | Study ongoing; not recruiting | March 2018 |
| Arm A – phase Ib – dose escalation | |||||
| Arm B – phase II | |||||
| Keynote 018 NCT02014636 [104] | I/II | Pembrolizumab + pazopanib | Treatment naïve patients with aRCC | Study ongoing; not recruiting | February 2019 |
| Part 1 – dose escalation | |||||
| Part 2 – randomized three arm | |||||
| NCT02133742 [105] | Ib | Pembrolizumab + axitinib | Treatment naïve aRCC (clear cell) | Study ongoing; not recruiting | April 2018 |
| Experimental: dose-finding and dose-expansion phase | |||||
| Keynote 29 NCT02089685 [106] | I/II | Pembrolizumab + pegylated IFNα-2b (PEG-IFN) | Previously treated aRCC (clear cell) and treatment naïve or treated advanced melanoma | Currently recruiting patients | June 2020 |
| Pembrolizumab + ipilimumab | |||||
| JAVELIN Renal 100 NCT02493751 [107] | Ib | Avelumab + axitinib | Treatment naïve aRCC (clear cell) | Currently recruiting patients | February 2019 |
| Experimental: dose-finding + dose-expansion phase | |||||
| NCT0197583 [108] | I | Durvalumab (MEDI4736) + tremelimumab IV | Patients with advanced solid tumours; RCC, colorectal, breast, ovarian and cervical | Ongoing but not recruiting | October 2017 (Primary end point) |
| NCT01984242 IMmotion150 [109] | II | Multicentre randomized, open-label study | Treatment naïve aRCC (clear cell +/or sarcomatoid) | Ongoing but not recruiting | August 2019 |
| Experimental arm A – atezolizumab + bevacizumab | |||||
| Experimental arm B – atezolizumab | |||||
| Comparator arm C – Sunitinib | |||||
| Checkmate 214 NCT02231749 [110] | III | Randomized, open-label study | Treatment naïve aRCC | Ongoing but not recruiting | September 2019 |
| Experimental: arm A: nivolumab + ipilimumab | |||||
| Active comparator: arm B: sunitinib 50 mg | |||||
| Keynote-426 NCT02853331 [111] | III | Randomized, open-label study | Treatment naïve aRCC (clear cell with or without sarcomatoid features) | Currently recruiting | January 2020 |
| Experimental arm – pembrolizumab + axitinib | |||||
| Comparator arm – sunitinib monotherapy | |||||
| IMmotion151 NCT02420821 [112] | III | Multicentre, randomized, open-label study | Treatment naïve aRCC (clear cell and/or component of sarcomatoid) | Ongoing but not recruiting | July 2020 |
| Experimental: atezolizumab + bevacizumab | |||||
| Active comparator: sunitinib | |||||
| JAVELIN Renal 101 NCT02684006 [113] | III | Experimental: avelumab + axitinib | Treatment naïve aRCC (clear cell) | Currently recruiting patients | September 2020 |
| Active comparator: sunitinib |
Abbreviations: Atezo, atezolizumab; BD, twice daily; Bev, bevacizumab; D1, day 1; Ipi, ipilimumab; Nivo: nivolumab, OD, once daily; Pembro, pembrolizumab; QD, four times daily.