Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020
Randomized Double-Blind Phase II Study of Maintenance Pembrolizumab Versus Placebo After First-Line Chemotherapy in Patients With Metastatic Urothelial Cancer.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 81 papers, 8 of them syntheses 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
81 citing papers in PubMed, 8 syntheses or guidelines pooled it, 130 citations in OpenAlex.
- Islet function impairment outcomes of immune checkpoint inhibitors in cancer patients: a systematic review and meta-analysis.Frontiers in immunology · 2026Pooled it
- The risk of endocrine immune-related adverse events induced by PD-1 inhibitors in cancer patients: a systematic review and meta-analysis.Frontiers in oncology · 2024Pooled it
- Immunotherapy for advanced or metastatic urothelial carcinoma.The Cochrane database of systematic reviews · 2023Pooled it
- Pooled it
- Switch Maintenance Therapy for Metastatic Urothelial Carcinoma.Bladder cancer (Amsterdam, Netherlands) · 2022Pooled it
- Risk of Infection with Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis.Targeted oncology · 2021Pooled it
- Efficacy of immune-checkpoint inhibitors in PD-L1 selected or unselected patients vs. control group in patients with advanced or metastatic urothelial carcinoma.Oncoimmunology · 2021Pooled it
- Immune Checkpoint Inhibitor Associated Hepatotoxicity in Primary Liver Cancer Versus Other Cancers: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2021Pooled it
- Camrelizumab Plus Nab-paclitaxel in Patients with Previously Treated Advanced Urothelial Carcinoma: A Multicenter Phase II Study.Cancer communications (London, England) · 2026Trial
- Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.Nature medicine · 2023Trial
- Enfortumab Vedotin With or Without Pembrolizumab in Cisplatin-Ineligible Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Avelumab First-Line Maintenance for Advanced Urothelial Carcinoma: Results From the JAVELIN Bladder 100 Trial After ≥2 Years of Follow-Up.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Trial
- Progression-Free Survival Effect Sizes in Randomized Controlled Trials of Targeted Cancer Therapies with Positive Outcomes.Acta haematologica · 2026Article
- A Tumor-Promoting Inflammatory SPP1+ Macrophage-IL6-CRP Axis Drives Immune Dysfunction in Bladder Cancer.Cancer discovery · 2026Article
- Efficacy and safety comparisons of PD-1 versus PD-L1 inhibitors in patients with solid cancer: a systematic review and meta-analysis.Journal of the National Cancer Center · 2026Article
- Unequal Access to Novel Systemic Therapies for Bladder Cancer: A Global Analysis of Clinical Trials of Immune Checkpoint Inhibitors and Antibody-Drug Conjugates.Current urology reports · 2026Review
- Immune-Related Adverse Events in Bladder Cancer Patients Treated With Immune Checkpoint Inhibitors: Insights From a FAERS Disproportionality Analysis.Cancer medicine · 2026Article
- Immune Checkpoint Inhibitor-induced Hepatitis, an Emerging Issue in Precision Cancer Therapy Era: A Narrative Literature Review.Rambam Maimonides medical journal · 2026Review
- A new era in CAR-NK cell therapy: from technological innovations to clinical applications.World journal of pediatrics : WJP · 2026Review
- Efficacy and safety of BCG and immune checkpoint inhibitors in non-muscle invasive bladder cancer: A meta-analysis with exploratory chemotherapy comparisons.Oncology letters · 2025Article
21 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 20 institutions in 1 country.
Funding
Abstract
purposePlatinum-based chemotherapy for first-line treatment of metastatic urothelial cancer is typically administered for a fixed duration followed by observation until progression. "Switch maintenance" therapy with PD-1 blockade at the time of chemotherapy cessation may be attractive for mechanistic and pragmatic reasons. PATIENTS AND
methodsPatients with metastatic urothelial cancer achieving at least stable disease on first-line platinum-based chemotherapy were enrolled. Patients were randomly assigned double-blind 1:1 to switch maintenance pembrolizumab 200 mg intravenously once every 3 weeks versus placebo for up to 24 months. Patients with disease progression on placebo could cross over to pembrolizumab. The primary objective was to determine the progression-free survival. Secondary objectives included determining overall survival as well as treatment outcomes according to PD-L1 combined positive score (CPS).
resultsBetween December 2015 and November 2018, 108 patients were randomly assigned to pembrolizumab (n = 55) or placebo (n = 53). The objective response rate was 23% with pembrolizumab and 10% with placebo. Treatment-emergent grade 3-4 adverse events occurred in 59% receiving pembrolizumab and 38% of patients receiving placebo. Progression-free survival was significantly longer with maintenance pembrolizumab versus placebo (5.4 months [95% CI, 3.1 to 7.3 months]
conclusionSwitch maintenance pembrolizumab leads to additional objective responses in patients achieving at least stable disease with first-line platinum-based chemotherapy and prolongs progression-free survival in patients with metastatic urothelial cancer.
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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.