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 |