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Table 1 Completed phase II or III clinical studies in genitourinary malignancies

From: Immunotherapy in genitourinary malignancies

Study Indication Dose Mechanism of action Result Common AE
HD-IL2 [11] Metastatic RCC, first line 600,000 or 720,000 IU/kg every 8 hourly up to 14 consecutive doses for 5 days every 2 weeks. Four to 6 cycles of treatment based on clinical and radiographic responses HD-IL2 stimulates proliferation and differentiation of T, B, and NK lymphocytes. It causes recruitment of tumor-infiltrating lymphocytes at tumor sites ORR was 14% with complete response (CR) seen in 5% patients and partial response (PR) in 9% of patients. Median duration of PR was 19 months Capillary leak syndrome, hypotension, fever and chills, anemia, nausea and vomiting, diarrhea, mental status changes, elevated liver enzymes and bilirubin, elevated BUN and creatinine, dyspnea, and pruritus
IFN-α plus bevacizumab vs. IFN-α [14, 15] Metastatic RCC, first line IFN-α (9 million units SC 3 times/week) with bevacizumab (10 mg/kg intravenously every 2 weeks) vs. IFN-α IFN-α is a cytokine with immune-modulatory and anti-proliferative activity Median PFS was 8.5 months for bevacizumab plus IFN-α (95% CI, 7.5 to 9.7 months) compared to 5.2 months (95% CI, 3.1 to 5.6 months) for IFN-α monotherapy.
Median OS (primary end point) 18.3 months for bevacizumab plus IFN-α compared to 17.4 months for IFN-α monotherapy
Fatigue, anorexia, nausea, proteinuria, neutropenia, and hypertension
Bevacizumab plus IFN-α vs. IFN-α plus placebo [16] Metastatic RCC, first line Bevacizumab (10 mg/kg every 2 weeks) with IFN-α (9 MIU SC 3 times/week) or same dose IFN-α with placebo IFN-α is a cytokine with immune-modulatory and anti-proliferative activity Median OS (primary end point) with bevacizumab/IFN-α was 23.3 months vs. 21.3 months.
At interim analysis, median PFS was significantly longer with bevacizumab/IFN-α vs. IFN-α/placebo (10.2 vs. 5.4 months and ORR 31 vs. 13%, respectively
Fatigue, asthenia, and neutropenia with IFN-α and proteinuria, hypertension, GI perforation, and bleeding with bevacizumab. There were 2% deaths related to treatment on both arms.
Nivolumab vs. everolimus [18] Metastatic RCC, Second line and beyond Nivolumab 3 mg/kg of body weight every 2 weekly vs. oral 10 mg everolimus tablet daily. Programmed death 1 (PD-1) checkpoint inhibitor Median OS was 25.0 months with nivolumab compared to 19.6 months with everolimus.
Median PFS 4.6 months with nivolumab compared to 4.4 with everolimus. The ORR was superior with nivolumab than everolimus
Nivolumab arm: fatigue, nausea, pruritus, diarrhea, anorexia, and rash
Atezolizumab [33, 34] Metastatic or advanced bladder cancer after platinum-based chemotherapy 1200 mg fixed dose intravenous every 3 weeks Programmed death-1 ligand (PD-L1) inhibitor ORR 15% in all patients with a complete response rate of 5%. Median duration of response not reached. Median PFS was 2.1 months and median OS 7.9 months Fatigue, nausea, poor appetite pruritus, anemia, hypertension, pneumonitis, increased AST, ALT, rash, and dyspnea
Sipuleucel-T vs. placebo [40, 41] Metastatic CRPC Three cycles intravenously every 2 weeks Dendritic cells activated using a fusion protein (PA2024) consisting of prostatic acid phosphatase (PAP) and GM-CSF Median OS was 25.8 months with sipuleucel compared to 21.7 months with placebo. PFS was not different between the two arms Sipuleucel-T: chills, fever, fatigue, back pain, and headache