Trial reportCancer medicine2021
A phase II trial of durvalumab and tremelimumab in metastatic, non-urothelial carcinoma of the urinary tract.
Trial report in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Durvalumab Plus Tremelimumab in Solid Tumors: A Systematic Review.Advances in therapy · 2021Pooled it
- Histological Subtypes and Divergent Differentiation of Urothelial Carcinoma: Histology, Genomics, and Management Implications.European urology · 2026Review
- Neuroendocrine Neoplasms of the Urinary Bladder: Integrating Molecular Advances into a Refined Classification System.Endocrine pathology · 2026Review
- Histological Subtypes of Bladder Cancer: Epidemiology, Molecular Biology, and Clinical Implications.Cancers · 2026Review
- Risk factors for immune checkpoint inhibitor colitis: a retrospective multi-center cohort study using electronic health records.Cancer immunology, immunotherapy : CII · 2026Article
- Review
- Differential NEUROD1, ASCL1, and POU2F3 Expression Defines Molecular Subsets of Bladder Small Cell/Neuroendocrine Carcinoma With Prognostic Implications.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2024Article
- One Size Fits Some: Approaching Rare Malignancies of the Urinary Tract.Current treatment options in oncology · 2024Review
- Frontiers and future of immunotherapy for pancreatic cancer: from molecular mechanisms to clinical application.Frontiers in immunology · 2024Review
- Article
- Long-term Outcomes of Local and Metastatic Small Cell Carcinoma of the Urinary Bladder and Genomic Analysis of Patients Treated With Neoadjuvant Chemotherapy.Clinical genitourinary cancer · 2022Article
- Checkpoint Inhibitor-Induced Colitis-A Clinical Overview of Incidence, Prognostic Implications and Extension of Current Treatment Options.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Small cell carcinoma of the bladder: Review of pathogenesis, presentation, and management.Bladder cancer (Amsterdam, Netherlands)Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 1 institution in 2 countries.
Funding
Abstract
backgroundImmune checkpoint blockade has made a significant impact on the clinical outcomes of patients with metastatic urothelial carcinoma (UC). However, evidence for this approach in patients with non-UC of the urinary tract is limited.
methodsThis was a phase II open-label study of durvalumab 1500 mg and tremelimumab 75 mg every 4 weeks for four cycles followed by durvalumab 1500 mg every 4 weeks. Eligible patients had metastatic non-UC with ECOG PS 0-1 regardless of prior therapy (except small cell carcinoma who were pretreated). The primary endpoint was overall response rate per RECIST v1.1. A Simon's minimax two-stage design was employed, with 13 patients planned for stage one. Pre-treatment tumors underwent PD-L1 staining and next-generation sequencing.
resultsThirteen patients were treated, including seven small cell carcinoma, three squamous cell carcinoma, and three adenocarcinoma. Eleven patients had visceral metastases. No responses were observed; 11 patients had PD and 2 patients had SD. Median PFS was 1.8 months (95% CI, 1.25-not reached [NR]) with a median follow-up of 7.38 months (range, 5.23-21.99 months). Median OS was 6.97 months (95% CI, 4.34-NR). One patient's tumor was PD-L1 positive and all sequenced tumors (n = 8) were microsatellite stable. Grades 3-4 treatment-related adverse events occurred in 38.4% of patients.
conclusionsIn a poor prognosis cohort of patients with non-UC, durvalumab and tremelimumab lacked clinical activity while demonstrating a manageable safety profile.
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Identifiers
What OpenQuestion holds
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.