Trial reportNature medicine2023
Gemcitabine and cisplatin plus nivolumab as organ-sparing treatment for muscle-invasive bladder cancer: a phase 2 trial.
Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03451331 (Randomized Phase 2 Trial of Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer), which is not on this map. Cited by 81 papers, 4 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.
Randomized Phase 2 Trial of Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer
Who cites it
81 citing papers in PubMed, 4 syntheses or guidelines pooled it, 121 citations in OpenAlex.
- Clinical complete response as a surrogate for pathological response in bladder cancer: a systematic review and meta-analysis.BJU international · 2026Pooled it
- The Local Effects of Systemic Therapies in Urological Oncology: A Systematic Review.Cancer medicine · 2026Pooled it
- Updated pan-tumor guidelines for neoadjuvant scoring of pathologic response: a joint SITC and INMC effort.Annals of oncology : official journal of the European Society for Medical Oncology · 2026Guideline
- Assessing clinical complete response after neoadjuvant systemic therapy in muscle-invasive bladder cancer: a systematic review.World journal of urology · 2025Pooled it
- Ipilimumab and nivolumab followed by chemoradiotherapy as bladder-sparing treatment in muscle-invasive bladder cancer: a phase 2 trial.Nature medicine · 2026Trial
- A pilot study of [European journal of nuclear medicine and molecular imaging · 2025Trial
- Phase II Trial of Risk-Enabled Therapy After Neoadjuvant Chemotherapy for Muscle-Invasive Bladder Cancer (RETAIN 1).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- Immunological biomarkers of response and resistance to treatment with cabozantinib and nivolumab in recurrent endometrial cancer.Journal for immunotherapy of cancer · 2025Trial
- Neoadjuvant Cisplatin-Based Chemotherapy Followed by Selective Bladder Preservation Chemoradiotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder: Post Hoc Analysis of Two Prospective Studies.Cancer research and treatment · 2024Trial
- Nivolumab plus Gemcitabine-Cisplatin in Advanced Urothelial Carcinoma.The New England journal of medicine · 2023Trial
- Reproducibility and diagnostic performance of ADC for assessing response to neoadjuvant immunotherapy in muscle-invasive bladder cancer: a multi-ROI comparison analysis from the phase-Ib NABUCCO trial.Insights into imaging · 2026Article
- Response evaluation of neoadjuvant therapy in MIBC: clinical trial-derived evidence to guide practice.BJU international · 2026Review
- Development and validation of a computational histology artificial intelligence-powered prognostic biomarker in muscle-invasive bladder cancer.Urologic oncology · 2026Article
- Nerve-sparing radical cystectomy in the era of perioperative enfortumab vedotin plus pembrolizumab: reappraising the value of functional preservation.Translational andrology and urology · 2026Article
- Interpreting the 39% clinical complete response rate in SURE-02: why the assessment pathway matters.Gland surgery · 2026Article
- Bladder preservation with disitamab vedotin plus PD-1 inhibitors and local intensification in muscle-invasive bladder cancer: a single-center retrospective cohort of 81 patients.International urology and nephrology · 2026Article
- Comparative efficacy of perioperative systemic therapies for muscle-invasive bladder cancer: a network meta-analysis of randomized trials.ESMO open · 2026Article
- AI-MIRACLE: Artificial Intelligence and MultIpaRAmetric MRI Predict CLinical OutcomEs to Neoadjuvant Immunotherapy in Patients with Muscle-invasive Bladder Cancer Undergoing Radical Cystectomy.European urology oncology · 2026Article
- Nucleotide excision repair in tumor response to DNA-damaging anticancer therapies: a comprehensive review.Journal of cancer research and clinical oncology · 2026Review
- Comparative insights into upper tract urothelial carcinoma: Aligning Chinese Urological Association and European Association of Urology guidelines with clinical practice.Asian journal of urology · 2026Article
21 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
40 authors at 9 institutions in 1 country.
Funding
Abstract
Cystectomy is a standard treatment for muscle-invasive bladder cancer (MIBC), but it is life-altering. We initiated a phase 2 study in which patients with MIBC received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging. Patients achieving a clinical complete response (cCR) could proceed without cystectomy. The co-primary objectives were to assess the cCR rate and the positive predictive value of cCR for a composite outcome: 2-year metastasis-free survival in patients forgoing immediate cystectomy or <ypT1N0 in patients electing immediate cystectomy. Seventy-six patients were enrolled; of these, 33 achieved a cCR (43%, 95% confidence interval (CI): 32%, 55%), and 32 of 33 who achieved a cCR opted to forgo immediate cystectomy. The positive predictive value of cCR was 0.97 (95% CI: 0.91, 1), meeting the co-primary objective. The most common adverse events were fatigue, anemia, neutropenia and nausea. Somatic alterations in pre-specified genes (ATM, RB1, FANCC and ERCC2) or increased tumor mutational burden did not improve the positive predictive value of cCR. Exploratory analyses of peripheral blood mass cytometry and soluble protein analytes demonstrated an association between the baseline and on-treatment immune contexture with clinical outcomes. Stringently defined cCR after gemcitabine, cisplatin, plus nivolumab facilitated bladder sparing and warrants further study. ClinicalTrials.gov identifier: NCT03451331 .
Indexed as
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.