Trial reportJournal for immunotherapy of cancer2023
Concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder: results from phase II study, BTCRC-GU15-023.
Trial report in Journal for immunotherapy of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02891161 (Phase Ib/II Study of Concurrent Durvalumab And Radiation Therapy), which is not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase Ib/II Study of Concurrent Durvalumab And Radiation Therapy (DUART) Followed by Adjuvant Durvalumab in Patients With Urothelial Cancer (T2-4 N0-2 M0) of the Bladder: Big Ten Cancer Research Consortium BTCRC-GU15-023
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.
- Immunotherapy in urological cancers: new paradigms and a systematic review of clinical trials and real-world evidence.Frontiers in oncology · 2026Pooled it
- Nivolumab adjuvant to chemo-radiation in localized muscle-invasive urothelial cancer: primary analysis of a multicenter, single-arm, phase II, investigator-initiated trial (NEXT).Journal for immunotherapy of cancer · 2025Trial
- Concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder: results from phase II study, BTCRC-GU15-023.Journal for immunotherapy of cancer · 2023Trial
- Isocyanate-Modified Melatplatin(IV) Enhances Antitumor Efficacy via TCF4/COL6A3-Mediated Extracellular Matrix Remodeling and cGAS-STING Pathway Activation in Bladder Cancer.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Bladder Preservation Therapy in Muscle-Invasive Bladder Cancer: Current Evidence and Future Directions.Journal of clinical medicine · 2026Review
- Tetra-modality bladder preservation with avelumab for muscle-invasive urothelial cancer: a phase II trial (TRIUMPH-B01).Future oncology (London, England) · 2025Article
- T cell subsets of urine-derived lymphocytes (UDLs) serve as an indicator of TILs and reflect immunological sex differences in bladder cancer.Journal for immunotherapy of cancer · 2025Article
- Bladder preservation alternatives in non-metastatic muscle-invasive bladder tumor: A systematic review and meta-analysis.Asian journal of urology · 2025Review
- Advancements in bladder cancer treatment: The synergy of radiation and immunotherapy.Oncotarget · 2025Review
- New Bladder Preservation Strategies in Urothelial Carcinoma of the Bladder.Deutsches Arzteblatt international · 2025Review
- The role of immunotherapy in targeting tumor microenvironment in genitourinary cancers.Frontiers in immunology · 2025Review
- Methylation cytometric pretreatment blood immune profiles with tumor mutation burden as prognostic indicators for survival outcomes in head and neck cancer patients on anti-PD-1 therapy.NPJ precision oncology · 2024Article
- Bladder-preserving radiation therapy for patients with locally advanced and node-positive bladder cancer.Clinical and translational radiation oncology · 2024Article
- Combining theranostic/particle therapy with immunotherapy for the treatment of GU malignancies.BJUI compass · 2024Review
- Circulating T cells: a promising biomarker of anti-PD-(L)1 therapy.Frontiers in immunology · 2024Review
- Research Progress of PD 1/PD L1 Inhibitors in the Treatment of Urological Tumors.Current cancer drug targets · 2024Review
- Immunotherapy for Urothelial Carcinoma: Current Evidence and Future Directions.Current urology reports · 2018Review
Corrections and comments
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Authors and funding
20 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundPatients with bladder cancer (BC) who are cisplatin ineligible or have unresectable disease have limited treatment options. Previously, we showed targeting programmed death-ligand 1 (PD-L1) with durvalumab (durva) and radiation therapy (RT) combination was safe in BC. We now report results from a phase II study evaluating the toxicity and efficacy of durva and RT in localized BC.
methodsThis is a single-arm, multi-institutional phase II study; N=26. Enrolled patients had pure or mixed urothelial BC (T2-4 N0-2 M0) with unresectable tumors and were unfit for surgery or cisplatin ineligible. Patients received durva concurrently with RT ×7 weeks, followed by adjuvant durva × 1 year. PRIMARY ENDPOINTS: (A) progression-free survival (PFS) at 1 year and (B) disease control rate (DCR) post adjuvant durva. Key secondary endpoints: (A) complete response (CR) post durvaRT (8 weeks), (B) overall survival (OS), (C) PFS and (D) toxicity. Correlative studies included evaluation of baseline tumor and blood (baseline, post durvaRT) for biomarkers.
resultsMedian follow-up was 27 months. Evaluable patients: 24/26 post durvaRT, 22/26 for DCR post adjuvant durva, all patients for PFS and OS. Post adjuvant durva, DCR was seen in 72.7%, CR of 54.5%. 1-year PFS was 71.5%, median PFS was 21.8 months. 1-year OS was 83.8%, median OS was 30.8 months. CR at 8 weeks post durvaRT was 62.5%. Node positive (N+) patients had similar median PFS and OS. DurvaRT was well tolerated. Grade ≥3 treatment-related adverse events: anemia, high lipase/amylase, immune-nephritis, transaminitis, dyspnea (grade 4-COPD/immune), fatigue, rash, diarrhea and scleritis. No difference in outcome was observed with PD-L1 status of baseline tumor. Patients with CR/PR or SD had an increase in naïve CD4 T cells, a decrease in PD-1+CD4 T cells at baseline and an increase in cytokine-producing CD8 T cells, including interferon gamma (IFNγ) producing cells, in the peripheral blood.
conclusionDurva with RT followed by adjuvant durva was safe with promising efficacy in localized BC patients with comorbidities, including N+ patients. Larger randomized studies, like S1806 and EA8185, are needed to evaluate the efficacy of combining immunotherapy and RT in BC. TRIAL REGISTRATION NUMBER: NCT02891161.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.