Table 1.
| Kidney cancer | ||||||
|---|---|---|---|---|---|---|
| Agent | Phase | Trial Status | Design/Description | Number Of Subjects | Results/Comments | Reference or NCCT Identifier |
| Nivolumab Monotherapy | III | Completed | Randomized, open- label study of anti-PD-1 versus the mTOR inhibitor everolimus in patients with advanced / metastatic RCC. Patients have received prior anti-angiogenic therapy. | 821 | Primary endpoint = OS 25 Vs.19.6 months | Motzer RJ et al NEJM 2015 |
| MPDL3280A (anti-PD-L1) +/- Avastinvs. Sunitinib | III | Ongoing | Randomized, open- label study comparing MPDL3280A + avastin to sunitinib alone in patients with untreated locally advanced or metastatic RCC | 550 | Primary endpoint = PFS, Secondary Endpoints = Overall RR/duration, OS, DOR, Adverse Event Incidence & pharmacokinetics | NCT02420821 |
| Nivolumab + Ipilimumab | III | Ongoing | Randomized open label study of nivolumab + ipilimumab compared with sunitinib monotherapy in previously untreated advanced or mRCC | 1070 | Primary Outcome Measures: Progression-free survival (PFS), Overall survival (OS) Secondary Outcome Measures: Objective response rate (ORR) & Adverse Event Incidence |
NCT02231749 |
| Prostate cancer | ||||||
| Agent | Phase | Trial Status/PC | Design/Description | Number of Subjects | Results/Comments | Reference or NCCT Identifier |
| Ipilimumab Monotherapy | III | Completed | Randomized, double blind trial of ipilimumabvs. placebo in pts with chemotherapy-naïve mCRPC | 600 | Primary endpoint- OS Secondary endpoints = PFS, pain progression, time to subsequent therapy and safety. Results- not yet reported |
NCT01057810 |
| Ipilimumab Following radiotherapy | III | Completed | Randomized, double blind trial of ipilimumabvs placebo following radiotherapy in patients previously treated with docetaxel | 799 | Primary endpoint = OS Secondary endpoints = PFS, pain response and safety OS- 11.2 vs 10 months (p=0.05) |
Kwon ED et al Lancet Onc. 2014 |
| Bladder cancer | ||||||
| Agent | Phase | Trial Status | Design/Description | Number Of Subjects | Results/Comments | Reference or NCCT Identifier |
| Pembrolizumab (anti-PD-1) monotherapy | III | Ongoing | Randomized open label stud of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Recurrent or Progressive Metastatic UC patients | 470 | Primary Outcome Measures: Overall survival (OS), Progression-free survival (PFS) per RECIST 1.1 | NCT02256436 |
| Atezolizumab (MPDL3280A) | III | Ongoing | Open-Label study in Patients With PD-L1-Selected, High-Risk Muscle Invasive UC patients after Cystectomy Randomized to Atezolizumab Vs. Observation as Adjuvant Therapy | 440 | Primary Outcome: Disease-Free Survival (DFS) Secondary Outcome: Overall Survival (OS), Disease-Specific Survival (DSS), Distant Metastasis-Free Survival (DMFS), Adverse Events (AEs), Percentage of Anti-Therapeutic Antibody (ATA) Response |
NCT02450331 |
| Atezolizumab (MPDL3280A) | III | Ongoing | Open label randomized study of Atezolizumab vs. chemotherapy in metastatic UC patients who have failed platinum based chemotherapy | 767 | Primary Outcome: Overall survival Secondary Outcome: Objective response rate (ORR), Progression-free survival (PFS), Duration of response (DOR), Incidence of adverse events (AEs), Incidence of anti-therapeutic antibodies to Atezolizumab | NCT02302807 |