Table 2.

Select ongoing clinical trials of immunotherapy in advanced RCC.

TreatmentSettingPhasePrimary endpointsIdentifier
Immune checkpoint inhibitors
 Relatlimab (anti-LAG-3)/nivolumabNeoadjuvant therapy of ccRCC2Pathologic response rateNCT05148546
 Botensilimab (anti-CTLA-4) + balstilimab (anti-PD-1)
vs Ipilimumab/nivolumab
1L advanced ccRCC2ORRNCT05928806
 Pembrolizumab + belzutifan + lenvatinib
or Pembrolizumab/quavonlimab (anti-CTLA-4) + lenvatinib
vs Pembrolizumab + lenvatinib
1L advanced ccRCC3PFS/OSNCT04736706
 Favezelimab (anti-LAG-3)/pembrolizumab + lenvatinib
or Vibostolimab (anti-TIGIT)/pembrolizumab + belzutifan
vs pembrolizumab + lenvatinib
1L advanced ccRCC1/2Lead-in phase: DLT; AEs
Efficacy phase: DLT; AEs; ORR
NCT04626479
 Relatlimab (anti-LAG-3)/nivolumab2L + advanced ccRCC after ICI2ORR, DOR, PFSNCT02996110
 Pembrolizumab/quavonlimab (anti-CTLA-4)
or favezelimab (anti-LAG-3)/pembrolizumab
or pembrolizumab + MK-4830 (ILT4 inhibitor)
2L + advanced ccRCC after ICI and TKI1/2Lead-in phase: DLT; AEs
Efficacy phase: DLT; AEs; ORR
NCT04626518
 INCAGN02385 (anti-LAG-3)Advanced solid tumors with progression after standard treatment1AEsNCT03538028
 Tiragolumab (anti-TIGIT) + atezolizumabAdvanced solid tumors with progression after standard treatment2ORRNCT03977467
CAR-T therapy
 CAR T-cells targeting CAIX3L + advanced RCC1AEsNCT04969354
 CAR T-cells targeting CD70Advanced solid tumors with progression after standard treatment1/2Phase 1: DLT; AEs
Phase 2: ORR
NCT05795595
 Allogeneic CAR T-cells targeting CD70advanced RCC refractory to ICI and TKI therapies1DLT; AEsNCT04696731
Bispecific antibodies
 Volrustomig (CTLA-4/PD-1 bispecific Ab) + lenvatinib1L advanced ccRCC1DLT; AEsNCT04522323
 AK112 (PD-1/VEGF bispecific Ab)Advanced solid tumors with progression after standard treatment1DLT; AEsNCT04047290
 XmAb819 (CD3/VEGF bispecific T-cell engager)advanced RCC refractory to ICI and TKI therapies1DLT; AEsNCT05433142
TreatmentSettingPhasePrimary endpointsIdentifier
Immune checkpoint inhibitors
 Relatlimab (anti-LAG-3)/nivolumabNeoadjuvant therapy of ccRCC2Pathologic response rateNCT05148546
 Botensilimab (anti-CTLA-4) + balstilimab (anti-PD-1)
vs Ipilimumab/nivolumab
1L advanced ccRCC2ORRNCT05928806
 Pembrolizumab + belzutifan + lenvatinib
or Pembrolizumab/quavonlimab (anti-CTLA-4) + lenvatinib
vs Pembrolizumab + lenvatinib
1L advanced ccRCC3PFS/OSNCT04736706
 Favezelimab (anti-LAG-3)/pembrolizumab + lenvatinib
or Vibostolimab (anti-TIGIT)/pembrolizumab + belzutifan
vs pembrolizumab + lenvatinib
1L advanced ccRCC1/2Lead-in phase: DLT; AEs
Efficacy phase: DLT; AEs; ORR
NCT04626479
 Relatlimab (anti-LAG-3)/nivolumab2L + advanced ccRCC after ICI2ORR, DOR, PFSNCT02996110
 Pembrolizumab/quavonlimab (anti-CTLA-4)
or favezelimab (anti-LAG-3)/pembrolizumab
or pembrolizumab + MK-4830 (ILT4 inhibitor)
2L + advanced ccRCC after ICI and TKI1/2Lead-in phase: DLT; AEs
Efficacy phase: DLT; AEs; ORR
NCT04626518
 INCAGN02385 (anti-LAG-3)Advanced solid tumors with progression after standard treatment1AEsNCT03538028
 Tiragolumab (anti-TIGIT) + atezolizumabAdvanced solid tumors with progression after standard treatment2ORRNCT03977467
CAR-T therapy
 CAR T-cells targeting CAIX3L + advanced RCC1AEsNCT04969354
 CAR T-cells targeting CD70Advanced solid tumors with progression after standard treatment1/2Phase 1: DLT; AEs
Phase 2: ORR
NCT05795595
 Allogeneic CAR T-cells targeting CD70advanced RCC refractory to ICI and TKI therapies1DLT; AEsNCT04696731
Bispecific antibodies
 Volrustomig (CTLA-4/PD-1 bispecific Ab) + lenvatinib1L advanced ccRCC1DLT; AEsNCT04522323
 AK112 (PD-1/VEGF bispecific Ab)Advanced solid tumors with progression after standard treatment1DLT; AEsNCT04047290
 XmAb819 (CD3/VEGF bispecific T-cell engager)advanced RCC refractory to ICI and TKI therapies1DLT; AEsNCT05433142

Abbreviations: 1L, first line; 2L+, second-line or later; 3L+, third-line or later; AEs, adverse events; CAIX, carbonic anhydrase IX; CAR-T, chimeric antigen receptor T cell; ccRCC, clear cell renal cell carcinoma; DLT, dose-limiting toxicity; ICI, immune checkpoint inhibitor; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; TKI, tyrosine kinase inhibitor.

Table 2.

Select ongoing clinical trials of immunotherapy in advanced RCC.

TreatmentSettingPhasePrimary endpointsIdentifier
Immune checkpoint inhibitors
 Relatlimab (anti-LAG-3)/nivolumabNeoadjuvant therapy of ccRCC2Pathologic response rateNCT05148546
 Botensilimab (anti-CTLA-4) + balstilimab (anti-PD-1)
vs Ipilimumab/nivolumab
1L advanced ccRCC2ORRNCT05928806
 Pembrolizumab + belzutifan + lenvatinib
or Pembrolizumab/quavonlimab (anti-CTLA-4) + lenvatinib
vs Pembrolizumab + lenvatinib
1L advanced ccRCC3PFS/OSNCT04736706
 Favezelimab (anti-LAG-3)/pembrolizumab + lenvatinib
or Vibostolimab (anti-TIGIT)/pembrolizumab + belzutifan
vs pembrolizumab + lenvatinib
1L advanced ccRCC1/2Lead-in phase: DLT; AEs
Efficacy phase: DLT; AEs; ORR
NCT04626479
 Relatlimab (anti-LAG-3)/nivolumab2L + advanced ccRCC after ICI2ORR, DOR, PFSNCT02996110
 Pembrolizumab/quavonlimab (anti-CTLA-4)
or favezelimab (anti-LAG-3)/pembrolizumab
or pembrolizumab + MK-4830 (ILT4 inhibitor)
2L + advanced ccRCC after ICI and TKI1/2Lead-in phase: DLT; AEs
Efficacy phase: DLT; AEs; ORR
NCT04626518
 INCAGN02385 (anti-LAG-3)Advanced solid tumors with progression after standard treatment1AEsNCT03538028
 Tiragolumab (anti-TIGIT) + atezolizumabAdvanced solid tumors with progression after standard treatment2ORRNCT03977467
CAR-T therapy
 CAR T-cells targeting CAIX3L + advanced RCC1AEsNCT04969354
 CAR T-cells targeting CD70Advanced solid tumors with progression after standard treatment1/2Phase 1: DLT; AEs
Phase 2: ORR
NCT05795595
 Allogeneic CAR T-cells targeting CD70advanced RCC refractory to ICI and TKI therapies1DLT; AEsNCT04696731
Bispecific antibodies
 Volrustomig (CTLA-4/PD-1 bispecific Ab) + lenvatinib1L advanced ccRCC1DLT; AEsNCT04522323
 AK112 (PD-1/VEGF bispecific Ab)Advanced solid tumors with progression after standard treatment1DLT; AEsNCT04047290
 XmAb819 (CD3/VEGF bispecific T-cell engager)advanced RCC refractory to ICI and TKI therapies1DLT; AEsNCT05433142
TreatmentSettingPhasePrimary endpointsIdentifier
Immune checkpoint inhibitors
 Relatlimab (anti-LAG-3)/nivolumabNeoadjuvant therapy of ccRCC2Pathologic response rateNCT05148546
 Botensilimab (anti-CTLA-4) + balstilimab (anti-PD-1)
vs Ipilimumab/nivolumab
1L advanced ccRCC2ORRNCT05928806
 Pembrolizumab + belzutifan + lenvatinib
or Pembrolizumab/quavonlimab (anti-CTLA-4) + lenvatinib
vs Pembrolizumab + lenvatinib
1L advanced ccRCC3PFS/OSNCT04736706
 Favezelimab (anti-LAG-3)/pembrolizumab + lenvatinib
or Vibostolimab (anti-TIGIT)/pembrolizumab + belzutifan
vs pembrolizumab + lenvatinib
1L advanced ccRCC1/2Lead-in phase: DLT; AEs
Efficacy phase: DLT; AEs; ORR
NCT04626479
 Relatlimab (anti-LAG-3)/nivolumab2L + advanced ccRCC after ICI2ORR, DOR, PFSNCT02996110
 Pembrolizumab/quavonlimab (anti-CTLA-4)
or favezelimab (anti-LAG-3)/pembrolizumab
or pembrolizumab + MK-4830 (ILT4 inhibitor)
2L + advanced ccRCC after ICI and TKI1/2Lead-in phase: DLT; AEs
Efficacy phase: DLT; AEs; ORR
NCT04626518
 INCAGN02385 (anti-LAG-3)Advanced solid tumors with progression after standard treatment1AEsNCT03538028
 Tiragolumab (anti-TIGIT) + atezolizumabAdvanced solid tumors with progression after standard treatment2ORRNCT03977467
CAR-T therapy
 CAR T-cells targeting CAIX3L + advanced RCC1AEsNCT04969354
 CAR T-cells targeting CD70Advanced solid tumors with progression after standard treatment1/2Phase 1: DLT; AEs
Phase 2: ORR
NCT05795595
 Allogeneic CAR T-cells targeting CD70advanced RCC refractory to ICI and TKI therapies1DLT; AEsNCT04696731
Bispecific antibodies
 Volrustomig (CTLA-4/PD-1 bispecific Ab) + lenvatinib1L advanced ccRCC1DLT; AEsNCT04522323
 AK112 (PD-1/VEGF bispecific Ab)Advanced solid tumors with progression after standard treatment1DLT; AEsNCT04047290
 XmAb819 (CD3/VEGF bispecific T-cell engager)advanced RCC refractory to ICI and TKI therapies1DLT; AEsNCT05433142

Abbreviations: 1L, first line; 2L+, second-line or later; 3L+, third-line or later; AEs, adverse events; CAIX, carbonic anhydrase IX; CAR-T, chimeric antigen receptor T cell; ccRCC, clear cell renal cell carcinoma; DLT, dose-limiting toxicity; ICI, immune checkpoint inhibitor; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; TKI, tyrosine kinase inhibitor.

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