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Table 2 Selected ongoing clinical studies in patients with genitourinary malignancies

From: Immunotherapy in genitourinary malignancies

No. Study Disease type Intervention/dose Mechanism of action Study phase and sponsor Primary endpoints
1. A Phase I Study of Hyperacute®-Renal (HAR) Immunotherapy In Patients With Metastatic Renal Cell Cancer (NCT02035358) Metastatic renal cell carcinoma Cells injected intradermally every week × 4 weeks and then every 2 weeks for 10 immunizations to total 14 immunizations.
Dose cohort 1:150 million cells per immunization;
Dose cohort 2: 300 million cells per immunization.
Two allogeneic renal cancer cell lines expressing murine α1,3 galactosidase gene Phase 1, NewLink Genetics Toxicity, DLT, and MTD
2. Neoadjuvant AGS-003 Immunotherapy in Patients With Localized Kidney Cancer (NCT02170389) Newly diagnosed advanced renal cell carcinoma, prior to nephrectomy or metatasectomy AGS-003 with sunitinib CD40L RNA-transfected autologous dendritic cell vaccine Phase 2, Argos Therapeutics Changes in immune biomarkers
3. Adjuvant Antigen Specific Immunotherapy in Patients With Advanced Renal Cell Carcinoma Using Tumor Associated Peptides (NCT02429440) UroRCC Renal cell carcinoma after resection or metatasectomy Arm 1: Intradermal application of peptide vaccine in combination with granulocyte macrophage colony-stimulating factor (GM-CSF)
Arm 2: Intradermal application of peptide vaccine with Montanide ISA-51
Synthetic adjuvant peptide with immune boosters Phase 1 and 2, University Hospital Tuebingen Safety and tolerability
4. Phase I Study of Neoadjuvant Nivolumab in Patients With Non-metastatic High-risk Clear Cell Renal Cell Carcinoma (NCT02575222) Clear cell renal cell carcinoma prior to nephrectomy Nivolumab at 3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy PD-1 inhibitor Phase 1, Sidney Kimmel Comprehensive Cancer Center Safety and tolerability
5. A Phase I/Ib, Open Label, Dose Finding Study to Evaluate Safety, Pharmacodynamics and Efficacy of Pembrolizumab in Combination With Vorinostat in Patients With Advanced Renal or Urothelial Cell Carcinoma (NCT02619253) Renal cell carcinoma or urinary bladder cancer Pembrolizumab and vorinostat Pembrolizumab: anti-PD-1 antibody and vorinostat is a histone deacetylase inhibitor Phase 1 and 2, Indiana University Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
6. Phase Ib Trial Of Pembrolizumab And Nintedanib (NCT02856425) Patients with any advanced solid tumors. Nintedanib
Pembrolizumab: anti-PD-1 antibody and nintedanib is a tyrosine kinase inhibitor to VEGF, FGFR, and PDGFR Phase 1, Gustave Roussy, Cancer Campus, Grand Paris Safety and MTD of the combination
7. A Phase Ib/II Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-muscle Invasive Bladder Cancer (NCT01625260) Non-muscle invasive bladder cancer ALT-801 gemcitabine ALT-801 is a recombinant protein, where IL2 is fused to T cell receptor directed to p53 Phase 1 and 2, Altor Bioscience Corporation Safety/efficacy study
8. The Effect of Atezolizumab in Combination With Gemcitabine/Carboplatin and Gemcitabine/Carboplatin Alone in Participants With Untreated Locally Advanced or Metastatic Urothelial Carcinoma Who Are Ineligible for Cisplatin-based Therapy [IMvigor130] (NCT02807636) Locally advanced or metastatic urothelial cancer, cisplatin ineligible patients for 1st line therapy Arm A: atezolizumab 1200 mg every 3 weeks with carboplatin AUC 4.5 day 1 every 3 weeks and gemcitabine 1000 mg/m2 days 1 and 8 every 3 weeks
Arm B: carboplatin with gemcitabine
Atezolizumab is a programmed death-1 ligand (PD-L1) inhibitor Phase 3 Efficacy, PFS, and OS
9. Randomized Phase 2 Trial of ACP-196 and Pembrolizumab Immunotherapy Dual CHECKpoint Inhibition In Platinum Resistant Metastatic Urothelial Carcinoma (RAPID CHECK Study) (NCT02351739) Metastatic Urothelial Carcinoma Arm 1: pembrolizumab
Arm 2: ACP-196 in combination with pembrolizumab
Pembrolizumab is a PD-1 inhibitor
Acalabrutinib (ACP-196) is as irreversible inhibitor of Bruton’s tyrosine kinase(BTK)
Phase 2
Acerta Pharma
Efficacy and safety
10. Phase I, Open-label Trial to Evaluate the Safety and Immunogenicity of INO-5150 Alone or in Combination With INO-9012 in Men With Biochemically Relapsed Prostate Cancer (NCT02514213) Biochemical or PSA recurrence of prostate adenocarcinoma Arm1: 2 mg INO-5150
Arm2: 8.5 mg INO-5150
Arm3: 2 mg INO-5150 plus 1 mg INO-9012
Arm4: 8.5 mg INO-5150 plus 1 mg INO-9012
Intramuscular delivery using electroporation
INO-5150 is a plasmid DNA vaccine encoding PSA and prostate-specific membrane antigen (PSMA).
INO-9012 is an IL2 immune activator
Phase 1
Inovio Pharmaceuticals
11. A Randomized, Placebo-Controlled Phase II Study of Multi-Epitope TARP Peptide Autologous Dendritic Cell Vaccination in Men With Stage D0 Prostate Cancer (NCT02362451) Biochemical or PSA recurrence of prostate adenocarcinoma Arm 1:lead in cohort
ME TARP vaccine
Arm 2: experimental arm
ME TARP vaccine
Arm 3:Autologus monocyte placebo
ME TARP is a multi-epitope T cell-receptor alternating reading frame protein expressed in 90-95% prostate cancer cells Phase II
National Cancer Institute
Safety and efficacy
12. Biomarker-Driven Therapy With Nivolumab and Ipilimumab in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Expressing AR-V7 (STARVE-PC) (NCT02601014) Metastatic CRPC patients with detectable AR‐V7 transcript in circulating tumor cells Nivolumab in combination with ipilimumab Nivolumab is a PD-1 inhibitor and ipilimumab is an anti-CTLA-4 antibody Phase 2, Johns Hopkins University/Sidney Kimmel Cancer Center Efficacy and safety
13. Docetaxel and PROSTVAC for Metastatic Castration Sensitive Prostate Cancer (NCT02649855) Metastatic CRPC Arm A: standard ADT followed by simultaneous docetaxel and PROSTVAC
Arm B: standard ADT followed by sequential docetaxel and PROSTVAC
PROSTVAC is a recombinant vaccinia virus encoding the human PSA Phase 2
National Cancer Institute
Biomarker, evaluating antigenic spreading and response at 19 weeks
14. A Phase II Single-Arm Multi-Center Trial Evaluating the Efficacy of Pembrolizumab in the Treatment of Subjects With Incurable Platinum-Refractory Germ Cell Tumors (NCT02499952) Incurable platinum-refractory germ cell tumors Pembrolizumab 200 mg every 3 weeks Anti PD-1 inhibitor Phase 2
Hoosier Cancer Research Network GU14-206
Safety and efficacy study
15. A Phase II Clinical Trial of Single Agent Pembrolizumab in Subjects With Advanced Adrenocortical Carcinoma (NCT02673333) Unresectable or metastatic adrenocortical carcinoma Pembrolizumab 200 mg every 3 weeks Anti-PD-1 inhibitor Phase 2
Memorial Sloan Kettering Cancer Center
Safety and efficacy study
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