| Treatment . | Setting . | Phase . | Primary endpoints . | Identifier . |
|---|---|---|---|---|
| TAM receptor TKI | ||||
| PF-07265807 (AXL and Mer receptor TKI) + Sasanlimab (anti-PD-1) + axitinib | Part 3: refractory advanced ccRCC Part 4: 1L advanced ccRCC with IMDC intermediate or poor risk | 1 | Part 3: DLT; AEs Part 4: ORR | NCT04458259 |
| PARP inhibitor | ||||
| Multi-arm platform trial: Olaparib (PARPi) monotherapy or cediranib (anti-VEGF-TKI) +/- olaparib or Durvalumab (anti-PD-L1) +/- olaparib | Neoadjuvant therapy of ccRCC | 2 | Changes in capillary permeability (without anti-PD-L1); changes in intra-tumoral CD8 + T cell infiltration (with anti-PD-L1) | NCT03741426 |
| Olaparib | 2L+ advanced RCC with select DDR alterations after ICI and/or TKI | 2 | ORR | NCT03786796 |
| Ceralasertib (ATR kinase inhibitor) +/- olaparib | 2L+ advanced ccRCC | 2 | ORR | NCT03682289 |
| Niraparib (PARPi) or Dostarlimab (anti-PD-1) | Cohort 3: 2L+ advanced ccRCC with select DDR alterations after anti-PD-1/anti-CTLA-4 doublet or ICI/TKI doublet | 2 | ORR | NCT04779151 |
| CDK inhibitor | ||||
| Abemaciclib (CDK4/6 inhibitor) + suntinib | 3L+ metastatic ccRCC after Ipilimumab/nivolumab and cabozantinib (IMDC intermediate/poor risk) | 1 | RP2D | NCT03905889 |
| Part 1: Palbociclib (CDK4/6 inhibitor) + belzutifan Part 2: Belzutifan + palbociclib vs. belzutifan alone | 3L+ advanced ccRCC after ICI and TKI | 1/2 | Phase 1: DLT; AEs Phase 2: ORR | NCT05468697 |
| Antibody-drug conjugate (ADC) | ||||
| DS-6000a (cadherin 6-directed deruxtecan ADC) | 2L+ advanced RCC | 1 | DLT; AEs | NCT04707248 |
| Radiopharmaceuticals | ||||
| Lu-177-girentuximab + nivolumab | 2L+ advanced ccRCC after ICI | 2 | MTD; ORR | NCT05239533 |
| Screening method: 68Ga-DPI-4452 Treatment intervention: 177Lu-DPI-4452 | Phase 1: 3L+ advanced ccRCC Phase 2: same criteria as phase 1 with CAIX-positive lesions on 68Ga-DPI-4452 imaging | 1/2 | Phase 1: DLT; AEs Phase 2: ORR | NCT05706129 |
| Lu-177-EB-PSMA-617 | treated or untreated RCC | n/a | safety assessed by CTCAE v4 | NCT05170555 |
| Radium-223 with cabozantinib | metastatic RCC with ≥2 metastatic bone lesions and ≤ 2 lines of prior treatment | 2 | Symptomatic skeletal event free survival | NCT04071223 |
| 177Lu-PSMA-1 | 3L + advanced ccRCC after ICI and TKI | 1/2 | AEs (phase 1); DCR (phase 2) | NCT06059014 |
| Treatment . | Setting . | Phase . | Primary endpoints . | Identifier . |
|---|---|---|---|---|
| TAM receptor TKI | ||||
| PF-07265807 (AXL and Mer receptor TKI) + Sasanlimab (anti-PD-1) + axitinib | Part 3: refractory advanced ccRCC Part 4: 1L advanced ccRCC with IMDC intermediate or poor risk | 1 | Part 3: DLT; AEs Part 4: ORR | NCT04458259 |
| PARP inhibitor | ||||
| Multi-arm platform trial: Olaparib (PARPi) monotherapy or cediranib (anti-VEGF-TKI) +/- olaparib or Durvalumab (anti-PD-L1) +/- olaparib | Neoadjuvant therapy of ccRCC | 2 | Changes in capillary permeability (without anti-PD-L1); changes in intra-tumoral CD8 + T cell infiltration (with anti-PD-L1) | NCT03741426 |
| Olaparib | 2L+ advanced RCC with select DDR alterations after ICI and/or TKI | 2 | ORR | NCT03786796 |
| Ceralasertib (ATR kinase inhibitor) +/- olaparib | 2L+ advanced ccRCC | 2 | ORR | NCT03682289 |
| Niraparib (PARPi) or Dostarlimab (anti-PD-1) | Cohort 3: 2L+ advanced ccRCC with select DDR alterations after anti-PD-1/anti-CTLA-4 doublet or ICI/TKI doublet | 2 | ORR | NCT04779151 |
| CDK inhibitor | ||||
| Abemaciclib (CDK4/6 inhibitor) + suntinib | 3L+ metastatic ccRCC after Ipilimumab/nivolumab and cabozantinib (IMDC intermediate/poor risk) | 1 | RP2D | NCT03905889 |
| Part 1: Palbociclib (CDK4/6 inhibitor) + belzutifan Part 2: Belzutifan + palbociclib vs. belzutifan alone | 3L+ advanced ccRCC after ICI and TKI | 1/2 | Phase 1: DLT; AEs Phase 2: ORR | NCT05468697 |
| Antibody-drug conjugate (ADC) | ||||
| DS-6000a (cadherin 6-directed deruxtecan ADC) | 2L+ advanced RCC | 1 | DLT; AEs | NCT04707248 |
| Radiopharmaceuticals | ||||
| Lu-177-girentuximab + nivolumab | 2L+ advanced ccRCC after ICI | 2 | MTD; ORR | NCT05239533 |
| Screening method: 68Ga-DPI-4452 Treatment intervention: 177Lu-DPI-4452 | Phase 1: 3L+ advanced ccRCC Phase 2: same criteria as phase 1 with CAIX-positive lesions on 68Ga-DPI-4452 imaging | 1/2 | Phase 1: DLT; AEs Phase 2: ORR | NCT05706129 |
| Lu-177-EB-PSMA-617 | treated or untreated RCC | n/a | safety assessed by CTCAE v4 | NCT05170555 |
| Radium-223 with cabozantinib | metastatic RCC with ≥2 metastatic bone lesions and ≤ 2 lines of prior treatment | 2 | Symptomatic skeletal event free survival | NCT04071223 |
| 177Lu-PSMA-1 | 3L + advanced ccRCC after ICI and TKI | 1/2 | AEs (phase 1); DCR (phase 2) | NCT06059014 |
Abbreviations: 1L, first line; 2L+, second-line or later; 3L+, third-line or later; AEs, adverse events; CAIX, carbonic anhydrase IX; ccRCC, clear cell renal cell carcinoma; CDK, cyclin-dependent kinase; DCR, disease control rate; DLT, dose-limiting toxicity; ICI, immune checkpoint inhibitor; ORR, overall response rate; OS, overall survival; PARPi, PARP inhibitor; PFS, progression-free survival; TKI, tyrosine kinase inhibitor
| Treatment . | Setting . | Phase . | Primary endpoints . | Identifier . |
|---|---|---|---|---|
| TAM receptor TKI | ||||
| PF-07265807 (AXL and Mer receptor TKI) + Sasanlimab (anti-PD-1) + axitinib | Part 3: refractory advanced ccRCC Part 4: 1L advanced ccRCC with IMDC intermediate or poor risk | 1 | Part 3: DLT; AEs Part 4: ORR | NCT04458259 |
| PARP inhibitor | ||||
| Multi-arm platform trial: Olaparib (PARPi) monotherapy or cediranib (anti-VEGF-TKI) +/- olaparib or Durvalumab (anti-PD-L1) +/- olaparib | Neoadjuvant therapy of ccRCC | 2 | Changes in capillary permeability (without anti-PD-L1); changes in intra-tumoral CD8 + T cell infiltration (with anti-PD-L1) | NCT03741426 |
| Olaparib | 2L+ advanced RCC with select DDR alterations after ICI and/or TKI | 2 | ORR | NCT03786796 |
| Ceralasertib (ATR kinase inhibitor) +/- olaparib | 2L+ advanced ccRCC | 2 | ORR | NCT03682289 |
| Niraparib (PARPi) or Dostarlimab (anti-PD-1) | Cohort 3: 2L+ advanced ccRCC with select DDR alterations after anti-PD-1/anti-CTLA-4 doublet or ICI/TKI doublet | 2 | ORR | NCT04779151 |
| CDK inhibitor | ||||
| Abemaciclib (CDK4/6 inhibitor) + suntinib | 3L+ metastatic ccRCC after Ipilimumab/nivolumab and cabozantinib (IMDC intermediate/poor risk) | 1 | RP2D | NCT03905889 |
| Part 1: Palbociclib (CDK4/6 inhibitor) + belzutifan Part 2: Belzutifan + palbociclib vs. belzutifan alone | 3L+ advanced ccRCC after ICI and TKI | 1/2 | Phase 1: DLT; AEs Phase 2: ORR | NCT05468697 |
| Antibody-drug conjugate (ADC) | ||||
| DS-6000a (cadherin 6-directed deruxtecan ADC) | 2L+ advanced RCC | 1 | DLT; AEs | NCT04707248 |
| Radiopharmaceuticals | ||||
| Lu-177-girentuximab + nivolumab | 2L+ advanced ccRCC after ICI | 2 | MTD; ORR | NCT05239533 |
| Screening method: 68Ga-DPI-4452 Treatment intervention: 177Lu-DPI-4452 | Phase 1: 3L+ advanced ccRCC Phase 2: same criteria as phase 1 with CAIX-positive lesions on 68Ga-DPI-4452 imaging | 1/2 | Phase 1: DLT; AEs Phase 2: ORR | NCT05706129 |
| Lu-177-EB-PSMA-617 | treated or untreated RCC | n/a | safety assessed by CTCAE v4 | NCT05170555 |
| Radium-223 with cabozantinib | metastatic RCC with ≥2 metastatic bone lesions and ≤ 2 lines of prior treatment | 2 | Symptomatic skeletal event free survival | NCT04071223 |
| 177Lu-PSMA-1 | 3L + advanced ccRCC after ICI and TKI | 1/2 | AEs (phase 1); DCR (phase 2) | NCT06059014 |
| Treatment . | Setting . | Phase . | Primary endpoints . | Identifier . |
|---|---|---|---|---|
| TAM receptor TKI | ||||
| PF-07265807 (AXL and Mer receptor TKI) + Sasanlimab (anti-PD-1) + axitinib | Part 3: refractory advanced ccRCC Part 4: 1L advanced ccRCC with IMDC intermediate or poor risk | 1 | Part 3: DLT; AEs Part 4: ORR | NCT04458259 |
| PARP inhibitor | ||||
| Multi-arm platform trial: Olaparib (PARPi) monotherapy or cediranib (anti-VEGF-TKI) +/- olaparib or Durvalumab (anti-PD-L1) +/- olaparib | Neoadjuvant therapy of ccRCC | 2 | Changes in capillary permeability (without anti-PD-L1); changes in intra-tumoral CD8 + T cell infiltration (with anti-PD-L1) | NCT03741426 |
| Olaparib | 2L+ advanced RCC with select DDR alterations after ICI and/or TKI | 2 | ORR | NCT03786796 |
| Ceralasertib (ATR kinase inhibitor) +/- olaparib | 2L+ advanced ccRCC | 2 | ORR | NCT03682289 |
| Niraparib (PARPi) or Dostarlimab (anti-PD-1) | Cohort 3: 2L+ advanced ccRCC with select DDR alterations after anti-PD-1/anti-CTLA-4 doublet or ICI/TKI doublet | 2 | ORR | NCT04779151 |
| CDK inhibitor | ||||
| Abemaciclib (CDK4/6 inhibitor) + suntinib | 3L+ metastatic ccRCC after Ipilimumab/nivolumab and cabozantinib (IMDC intermediate/poor risk) | 1 | RP2D | NCT03905889 |
| Part 1: Palbociclib (CDK4/6 inhibitor) + belzutifan Part 2: Belzutifan + palbociclib vs. belzutifan alone | 3L+ advanced ccRCC after ICI and TKI | 1/2 | Phase 1: DLT; AEs Phase 2: ORR | NCT05468697 |
| Antibody-drug conjugate (ADC) | ||||
| DS-6000a (cadherin 6-directed deruxtecan ADC) | 2L+ advanced RCC | 1 | DLT; AEs | NCT04707248 |
| Radiopharmaceuticals | ||||
| Lu-177-girentuximab + nivolumab | 2L+ advanced ccRCC after ICI | 2 | MTD; ORR | NCT05239533 |
| Screening method: 68Ga-DPI-4452 Treatment intervention: 177Lu-DPI-4452 | Phase 1: 3L+ advanced ccRCC Phase 2: same criteria as phase 1 with CAIX-positive lesions on 68Ga-DPI-4452 imaging | 1/2 | Phase 1: DLT; AEs Phase 2: ORR | NCT05706129 |
| Lu-177-EB-PSMA-617 | treated or untreated RCC | n/a | safety assessed by CTCAE v4 | NCT05170555 |
| Radium-223 with cabozantinib | metastatic RCC with ≥2 metastatic bone lesions and ≤ 2 lines of prior treatment | 2 | Symptomatic skeletal event free survival | NCT04071223 |
| 177Lu-PSMA-1 | 3L + advanced ccRCC after ICI and TKI | 1/2 | AEs (phase 1); DCR (phase 2) | NCT06059014 |
Abbreviations: 1L, first line; 2L+, second-line or later; 3L+, third-line or later; AEs, adverse events; CAIX, carbonic anhydrase IX; ccRCC, clear cell renal cell carcinoma; CDK, cyclin-dependent kinase; DCR, disease control rate; DLT, dose-limiting toxicity; ICI, immune checkpoint inhibitor; ORR, overall response rate; OS, overall survival; PARPi, PARP inhibitor; PFS, progression-free survival; TKI, tyrosine kinase inhibitor
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