Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2020
Neoadjuvant Nivolumab for Patients With Resectable Merkel Cell Carcinoma in the CheckMate 358 Trial.
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. It is linked to 2 registered trials, which are not on this map. Cited by 146 papers, 5 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.
Window-of-opportunity Study of Chemo-immunotherapy in Patients With Resectable Merkel Cell Carcinoma Prior to Surgery: the MERCURY Trial
Merkel Cell Carcinoma Clinical Trials: What Are Prevailing Patient Experiences in Merkel Cell Carcinoma Studies
Who cites it
146 citing papers in PubMed, 5 syntheses or guidelines pooled it, 267 citations in OpenAlex.
- 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
- Society for Immunotherapy of Cancer: updates and best practices for multiplex immunohistochemistry (IHC) and immunofluorescence (IF) image analysis and data sharing.Journal for immunotherapy of cancer · 2025Guideline
- Efficacy and safety of PD-1/PD-L1 inhibitors in patients with Merkel Cell Carcinoma: a systematic review and Meta-analysis.BMC cancer · 2024Pooled it
- Merkel-cell carcinoma: ESMO-EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up.ESMO open · 2024Guideline
- Safety of Neoadjuvant Immunotherapy in Resectable Cancers: A Meta-Analysis.Frontiers in immunology · 2022Pooled it
- Neoadjuvant lenvatinib plus pembrolizumab in Merkel cell carcinoma: an investigator-initiated, open-label phase II trial.Journal for immunotherapy of cancer · 2026Trial
- Pembrolizumab for the First-Line Treatment of Recurrent Locally Advanced or Metastatic Merkel Cell Carcinoma: Results from the Single-Arm, Open-Label, Phase III KEYNOTE-913 Study.American journal of clinical dermatology · 2024Trial
- Biomarker Analyses Investigating Disease Biology and Associations with Outcomes in the JAVELIN Merkel 200 Trial of Avelumab in Metastatic Merkel Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024Trial
- Trial
- Neoadjuvant nivolumab for patients with resectable HPV-positive and HPV-negative squamous cell carcinomas of the head and neck in the CheckMate 358 trial.Journal for immunotherapy of cancer · 2021Trial
- Three-year survival, correlates and salvage therapies in patients receiving first-line pembrolizumab for advanced Merkel cell carcinoma.Journal for immunotherapy of cancer · 2021Trial
- Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020Trial
- Durable Tumor Regression and Overall Survival in Patients With Advanced Merkel Cell Carcinoma Receiving Pembrolizumab as First-Line Therapy.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019Trial
- Editorial: The Critical Role of Surgery for Local Disease Control and Nodal Assessment in Merkel Cell Carcinoma.Annals of surgical oncology · 2026Article
- Rate of growth of Merkel cell carcinoma: a unique photographic evidence.Dermatology reports · 2026Article
- Advances in the management of neuroendocrine tumours: Evidence from a systematic review.Biomedical reports · 2026Article
- Pan-tumor harmonization of pathologic response assessment for standardized data collection in neoadjuvant trials (PATHdata): results of a Society for Immunotherapy of Cancer multi-institutional reproducibility study.Annals of oncology : official journal of the European Society for Medical Oncology · 2026Article
- Neoadjuvant therapy in skin cancer: current evidence and future perspectives.Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG · 2026Review
- Precision immunotherapy for head and neck cancer: therapeutic combinations, biomarker strategies, and translational challenges.Molecular cancer · 2026Review
- Efficacy of Immune Checkpoint Inhibitors and Oncoviruses in Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026Review
86 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
24 authors at 15 institutions in 5 countries.
Funding
Abstract
purposeMerkel cell carcinoma (MCC) is a rare, aggressive skin cancer commonly driven by the Merkel cell polyomavirus (MCPyV). The programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) immunosuppressive pathway is often upregulated in MCC, and advanced metastatic MCC frequently responds to PD-1 blockade. We report what we believe to be the first trial of anti-PD-1 in the neoadjuvant setting for resectable MCC.
methodsIn the phase I/II CheckMate 358 study of virus-associated cancer types, patients with resectable MCC received nivolumab 240 mg intravenously on days 1 and 15. Surgery was planned on day 29. Tumor regression was assessed radiographically and microscopically. Tumor MCPyV status, PD-L1 expression, and tumor mutational burden (TMB) were assessed in pretreatment tumor biopsies.
resultsThirty-nine patients with American Joint Committee on Cancer stage IIA-IV resectable MCC received ≥ 1 nivolumab dose. Three patients (7.7%) did not undergo surgery because of tumor progression (n = 1) or adverse events (n = 2). Any-grade treatment-related adverse events occurred in 18 patients (46.2%), and grade 3-4 events in 3 patients (7.7%), with no unexpected toxicities. Among 36 patients who underwent surgery, 17 (47.2%) achieved a pathologic complete response (pCR). Among 33 radiographically evaluable patients who underwent surgery, 18 (54.5%) had tumor reductions ≥ 30%. Responses were observed regardless of tumor MCPyV, PD-L1, or TMB status. At a median follow-up of 20.3 months, median recurrence-free survival (RFS) and overall survival were not reached. RFS significantly correlated with pCR and radiographic response at the time of surgery. No patient with a pCR had tumor relapse during observation.
conclusionNivolumab administered approximately 4 weeks before surgery in MCC was generally tolerable and induced pCRs and radiographic tumor regressions in approximately one half of treated patients. These early markers of response significantly predicted improved RFS. Additional investigation of these promising findings is warranted.
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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 Socratic graph.