Table 6:
Ongoing clinical trials.
| Clinical trial | Phase | Experimental and control arms | Histology | Outcomes (*primary) |
Estimated primary completion date |
|---|---|---|---|---|---|
| NCT02019693(52) | II | Capmatinib (INC280) | RCC | ORR at 4–5 years* | December 2021 (no results posted yet) |
| NCT04535687(93) | II | Fluzoparib | RCC | ORR at 3 months* Radiographic PFS at 6 months OS at 18 months TTP at 6 months Adverse events |
March 2022 (no results posted yet) |
|
NCT04644432(95) (INDIGO) |
II | For patients with a DNA mutation that matches a targeted treatment, one of the following are administered: erlotinib, osimertinib, alectinib, dabrafenib + trametinib, trastuzumab, olaparib, pembrolizumab, cabozantinib, crizotinib, palbociclib, imatinib vs. sunitinib for patients with an angiogen profile vs. nivolumab for patients with an immune profile (or no immune, angiogen, or targeted mutation profile) |
RCC and other urogenital neoplasms | ORR at 30 months* TTF at 30 months* OS at 30 months PFS at 30 months Disease control rate at 30 months Patient-reported outcomes via PRO-CTCAE questionnaire QoL per EORTC QLQ-C30 questionnaire Adverse events |
September 2022 (no results posted yet) |
|
NCT03685448(92) (ANZUP) |
II | Cabozantinib | RCC, pRCC, chRCC, tRCC, RCC with sarcomatoid components | ORR at 2 years* Adverse events PFS at 2 years OS at 2 years |
October 2022 (no results posted yet) |
| NCT01130519(42) | II | Bevacizumab + erlotinib | HLRCC, sporadic pRCC | ORR at 4–5 years* PFS Duration of response OS at 4–5 years |
December 2022 (no results posted yet) |
|
NCT 03866382(91)
(ICONIC) |
II | Cabozantinib + nivolumab + ipilimumab | pRCC, chRCC, CDC, RMC, RCC with sarcomatoid components, and other rare GU tract cancers (bladder, prostate, testicular, penile) | ORR up to 5 years* Duration of response (CR or PR up to 5 years) PFS up to 5 years Overall survival up to 5 years Clinical benefit rate up to 5 years Incidence of adverse events Effects of treatment in patients with bone-only disease |
February 2023 (no results posted yet) |
|
NCT02819596(94)
(CALYPSO) |
Ib | Savolitinib vs. durvalumab vs. savolitinib + durvalumab vs. tremelimumab + durvalumab |
ccRCC and pRCC | Phase Ib: dose limiting toxicity*
ORR at 18 months in clear cell RCC* ORR at 18 months in PRCC* Pharmacokinetics PFS at 18 months OS at 18 months |
March 2023 (no results posted yet) |
|
NCT03117309(86) (HCRN: GU16-260) |
II | Nivolumab vs. nivolumab + ipilimumab |
RCC | PFS at 1 year* ORR at 1 year RR at 1 year CR, PR, and SD at 1 year PFS at 1 year Toxicity |
September 2023 |
|
NCT04090710(89)
(CYTOSHRINK) |
II | Ipilimumab + nivolumab followed by SBRT vs. ipilimumab + nivolumab |
RCC | PFS at 2 years* Safety (incidence of death) OS at 2 years ORR at 1 year QoL per EORTC QLQ-C30 questionnaire Adverse events Drug tolerability and discontinuation rates Changes in blood immune signatures and changes in stool microbiome |
December 2023 |
| NCT04413123(90) | II | Cabozantinib + nivolumab + ipilimumab | RCC and nccRCC (pRCC, chRCC, tRCC, CDC, RMC), unclassified RCC | ORR up to 21 months* Duration of response PFS up to 21 months OS Adverse events QoL per FKSI-19 scale and BFI questionnaire |
December 2024 |
| NCT04981509(43) | II | Bevacizumab + Atezolizumab + Erlotinib | HLRCC, sporadic pRCC | Incidence of adverse events up to 28 days after treatment* ORR up to 3 years (CR + PR)* Disease control rate up to 3 years* PFS up to 3 years* OS up to 3 years* Duration of response up to 3 years* Response to treatment up to 3 years* |
December 2024 |
|
NCT03075423(85) (SUNNIFORECAST) |
II | Ipilimumab + nivolumab vs. standard of care decided by physician | nccRCC (at least 50% non-clear cell component according to WHO classification) | OS at 12 months* OS at 6 and 18 months OS at 5 years PFS at 5 years ORR at 4 years Incidence of TRAE QoL per FKSI–DRS questionnaire |
June 2025 |
|
NCT04267120(87)
(LENKYN) |
II | Lenvatinib + pembrolizumab | RCC | ORR at 2 years* Safety and tolerability measured via adverse events PFS at 3 months and at 12 months OS at 6, 12 , 18 months, and up to 4 years |
July 2027 |
ORR: overall response rate, PFS: progression-free survival, OS: overall survival, TTP: time to progression, QoL: quality of life, RR: response rate, CR: complete response, PR: partial response, SD: stable disease.