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Immunotherapy and Immune Responses / Bladder and Urothelial Cancer Treatments · Review
Frontiers in Oncology · August 12, 2026
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This systematic review of 53 phase II/III trials and real-world evidence confirms immunotherapy as a cornerstone of urological oncology, with established regimens (EV+pembrolizumab in bladder, dual ICI in renal, sipuleucel-T in prostate) now standard of care. Emerging data support biomarker-driven approaches and immunoradiotherapy combinations, though real-world implementation reveals gaps in access and performance status as a dominant prognostic factor.
Systematic review of phase II/III randomized controlled trials, immunoradiotherapy trials, observational studies, and disease registries. Patients with bladder cancer, renal cell carcinoma, or prostate cancer enrolled in phase II/III trials, immunoradiotherapy studies, observational cohorts, or disease registries (2010–2026). Intervention: Immune checkpoint inhibitors (durvalumab, pembrolizumab, atezolizumab, tremelimumab, toripalimab), antibody-drug conjugates (Enfortumab Vedotin, disitamab vedotin), cancer vaccines (sipuleucel-T, personalized peptide vaccines), cellular th…. Compared with: Standard of care, radiotherapy alone, or comparator arms in individual trials (specific comparators vary by trial).
In bladder cancer, EV+pembrolizumab became frontline standard for metastatic disease; durvalumab and EV+pembrolizumab improved MIBC outcomes Immunoradiotherapy combinations in bladder cancer showed complete response rates of 64–88% with potential for bladder-sparing In kidney cancer, dual ICI and ICI+TKI combinations demonstrated long-term survival benefits; durvalumab±tremelimumab introduced as adjuvant therapy
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Clinicians should recognize immunotherapy combinations (EV+pembrolizumab in metastatic bladder cancer, dual ICI in renal cancer, adjuvant durvalumab±tremelimumab) as now-established standards, and consider biomarker-driven approaches and immunoradiotherapy combinations as emerging options. Implementation should attend to access barriers and performance status as a dominant prognostic factor identified in real-world practice.
Systematic review synthesizing 53 phase II/III clinical trials across urological cancers with established endpoints and real-world corroboration, demonstrating efficacy of multiple immunotherapy regimens and combinations that have become standards of care.
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Clinicians should recognize immunotherapy combinations (EV+pembrolizumab in metastatic bladder cancer, dual ICI in renal cancer, adjuvant durvalumab±tremelimumab) as now-established standards, and consider biomarker-driven approaches and immunoradiotherapy combinations as emerging options. Implementation should attend to access barriers and performance status as a dominant prognostic factor identified in real-world practice.
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Introduction The therapeutic landscape of urological cancers has undergone a paradigm shift with the advent of immunotherapy. This systematic review synthesizes clinical trials that have established new standards of care, complemented by evidence on immunotherapy-radiotherapy combinations and real-world data. Methods A comprehensive search of PubMed/MEDLINE and Embase (2010–2026) identified phase II/III trials evaluating ICIs, ADCs, vaccines, or cellular therapies, as well as immunoradiotehrapy, observational studies, and registries reporting real-world outcomes. Results Fifty-three clinical trials met the inclusion criteria: bladder cancer (n=14), kidney cancer (n=21), and prostate cancer (n=18), complemented by immunoradiotherapy trials (n=20), and real-world evidence (n=19). In bladder cancer, perioperative durvalumab and Enfortumab Vedotin (EV) plus pembrolizumab improved outcomes in MIBC, and the EV+pembrolizumab combination became a frontline standard for metastatic disease. Disitamab vedotin plus toripalimab improved outcomes in HER2-expressing tumours, and ctDNA-guided adjuvant atezolizumab introduces precision therapy for molecular residual disease. Emerging immunoradiotherapy combinations showed promising bladder-sparing potential (CR rates 64-88%). In kidney cancer, dual ICI and ICI+TKI combinations demonstrated long-term survival benefits. The RAMPART trial introduced adjuvant durvalumab ± tremelimumab, while transcriptomic-guided therapy and treatment of rare translocation RCC emerged from 2025–2026 trials. In prostate cancer, sipuleucel-T remains the first approved cancer vaccine, while newer trials explored ICIs (durvalumab+tremelimumab) and personalized peptide vaccines. Biomarker-driven approaches emerged across all tumor types, including ctDNA-guided therapy in bladder cancer, KIM 1 in kidney cancer, and PD-L1/DDR status in prostate cancer. Immunoradiotherapy combinations demonstrated activity in mCRPC (CA184-043, 5-year OS 7.9% vs 2.7%) and oligometastatic RCC (RAPPORT, ORR 63%). Real-world evidence confirmed trial findings while revealing critical gaps in access, the prognostic dominance of performance status, and the potential for radiotherapy-immunotherapy synergy. Conclusion Immunotherapy has become a cornerstone of urological oncology. Current paradigms include early ICI/ADC intensification in bladder cancer, ICI-based combinations in renal cell carcinoma, and the gradual integration of vaccines and checkpoint inhibitors in prostate cancer. Real-world evidence and immunoradiotherapy represents an emerging frontier, though optimal fractionation and sequencing require further investigation. Despite major advances, challenges remain in overcoming resistance, optimizing sequencing, and ensuring equitable access.
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