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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

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

Safety

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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