Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2023
Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 140 papers, 6 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
140 citing papers in PubMed, 6 syntheses or guidelines pooled it, 162 citations in OpenAlex.
- Antibody-Drug Conjugates for Locally Advanced and Metastatic Urothelial Carcinoma: A Systematic Review and Meta-Analysis.JAMA network open · 2026Pooled it
- Enfortumab Vedotin With or Without Pembrolizumab in Metastatic Urothelial Carcinoma: A Systematic Review and Meta-Analysis.JAMA network open · 2025Pooled it
- Effectiveness and safety of PD-1/L1 inhibitors as first-line therapy for patients with advanced or metastatic urothelial carcinoma who are ineligible for platinum-based chemotherapy: a meta-analysis.Frontiers in immunology · 2025Pooled it
- Antibody-drug conjugates as game changers in bladder cancer: current progress and future directions.Frontiers in immunology · 2025Pooled it
- Efficacy and safety of antibody-drug conjugates in the treatment of urothelial cell carcinoma: a systematic review and meta-analysis of prospective clinical trials.Frontiers in pharmacology · 2024Pooled it
- Efficacy and safety of first-line immunotherapy-containing regimens compared with chemotherapy for advanced or metastatic urothelial carcinoma: a network meta-analysis of randomized controlled trials.Frontiers in oncology · 2024Pooled it
- Trial
- Mirvetuximab soravtansine plus pembrolizumab in recurrent folate receptor alpha-positive uterine serous carcinoma: a phase II trial.Nature communications · 2026Trial
- Phase II Trial of Enfortumab Vedotin in Patients With Previously Treated Advanced Head and Neck Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Patient-Reported Outcomes in Patients With Advanced Urothelial Cancer Who Are Ineligible for Cisplatin and Treated With First-Line Enfortumab Vedotin Alone or With Pembrolizumab.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- Toxicity attribution during enfortumab vedotin plus pembrolizumab therapy in urothelial carcinoma: a practical framework.The oncologist · 2026Review
- Exploring the immunological effects of antibody-drug conjugates.Nature reviews. Clinical oncology · 2026Review
- Immune checkpoint blockade reshapes drug-associated toxicity: a pharmacovigilance atlas of drug-ICI interactions.medRxiv : the preprint server for health sciences · 2026Article
- Exposure-Response Analysis of Enfortumab Vedotin Plus Pembrolizumab as First-Line Therapy for Locally Advanced or Metastatic Urothelial Cancer.Clinical pharmacology and therapeutics · 2026Article
- Prophylactic intravenous dexamethasone is associated with reduced cutaneous toxicity during first-line enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma: a multicenter prospective cohort study.International journal of clinical oncology · 2026Article
- Coordinated Expression of ADC TargetsCurrent issues in molecular biology · 2026Article
- Review
- Infectious Complications of Antibody-Drug Conjugates: A Review of Safety Data from FDA-Approved Agents.Current oncology reports · 2026Review
- First-Line Enfortumab Vedotin Plus Pembrolizumab vs Gemcitabine Plus Cisplatin for Metastatic Urothelial Carcinoma.JAMA network open · 2026Article
- Toripalimab plus disitamab vedotin versus tislelizumab-based combination in advanced urothelial carcinoma: a real-world comparative study.BMC cancer · 2026Article
80 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
25 authors at 20 institutions in 5 countries.
Funding
Abstract
purposePatients with locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible for cisplatin-based therapy have limited first-line (1L) treatment options and significant need for improved therapies. Enfortumab vedotin (EV) and pembrolizumab (Pembro) individually have shown a survival benefit in urothelial cancer in second-line + la/mUC settings. Here, we present data from the pivotal trial of EV plus Pembro (EV + Pembro) in the 1L setting. PATIENTS AND
methodsIn Cohort K of the EV-103 phase Ib/II study, cisplatin-ineligible patients with previously untreated la/mUC were randomly assigned 1:1 to receive EV as monotherapy or in combination with Pembro. The primary end point was confirmed objective response rate (cORR) per blinded independent central review. Secondary end points included duration of response (DOR) and safety. There were no formal statistical comparisons between treatment arms.
resultsThe cORR was 64.5% (95% CI, 52.7 to 75.1) and 45.2% (95% CI, 33.5 to 57.3) for patients treated with EV + Pembro (N = 76) and EV monotherapy (N = 73), respectively. The median DOR was not reached for the combination and was 13.2 months for monotherapy; 65.4% and 56.3% of patients who responded to the combination and monotherapy, respectively, maintained a response at 12 months. The most common grade 3 or higher treatment-related adverse events (TRAEs) in patients treated with the combination were maculopapular rash (17.1%), fatigue (9.2%), and neutropenia (9.2%). EV TRAEs of special interest (any grade) in the combination arm included skin reactions (67.1%) and peripheral neuropathy (60.5%).
conclusionEV + Pembro showed a high cORR with durable responses as 1L treatment in cisplatin-ineligible patients with la/mUC. Patients who received EV monotherapy had a response and safety profile consistent with previous studies. Adverse events for EV + Pembro were manageable, with no new safety signals observed.
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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.