Trial reportCancer science2017
Efficacy and safety of nivolumab in Japanese patients with previously untreated advanced melanoma: A phase II study.
Trial report in Cancer science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 10 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
50 citing papers in PubMed, 10 syntheses or guidelines pooled it.
- Patients with melanoma treated with immune checkpoint inhibitors who had non-thyroid endocrine and skin immune-related adverse events have better prognosis: A systematic review and meta-analysis.Frontiers in oncology · 2022Pooled it
- Immune-related adverse events: promising predictors for efficacy of immune checkpoint inhibitors.Cancer immunology, immunotherapy : CII · 2021Pooled it
- Guidelines for clinical evaluation of anti-cancer drugs.Cancer science · 2021Guideline
- Association of Immune Related Adverse Events With Efficacy of Immune Checkpoint Inhibitors and Overall Survival in Cancers: A Systemic Review and Meta-analysis.Frontiers in oncology · 2021Pooled it
- Treatment-Related Serious Adverse Events of Immune Checkpoint Inhibitors in Clinical Trials: A Systematic Review.Frontiers in oncology · 2021Pooled it
- Prevalence of dermatological toxicities in patients with melanoma undergoing immunotherapy: Systematic review and meta-analysis.PloS one · 2021Pooled it
- Meta-analysis of immune-related adverse events of immune checkpoint inhibitor therapy in cancer patients.Thoracic cancer · 2020Pooled it
- Potential Immune-Related Adverse Events Associated With Monotherapy and Combination Therapy of Ipilimumab, Nivolumab, and Pembrolizumab for Advanced Melanoma: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2020Pooled it
- The role of vascular mimicry as a biomarker in malignant melanoma: a systematic review and meta-analysis.BMC cancer · 2019Pooled it
- Treatment-Related Adverse Events of PD-1 and PD-L1 Inhibitors in Clinical Trials: A Systematic Review and Meta-analysis.JAMA oncology · 2019Pooled it
- Five-year survival with nivolumab in previously untreated Japanese patients with advanced or recurrent malignant melanoma.The Journal of dermatology · 2021Trial
- PLA1A expression as a diagnostic marker of BRAF-mutant metastasis in melanoma cancer.Scientific reports · 2021Trial
- Trial
- A phase 3 study of nivolumab in previously treated advanced gastric or gastroesophageal junction cancer (ATTRACTION-2): 2-year update data.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2020Trial
- Long-term follow up of nivolumab in previously untreated Japanese patients with advanced or recurrent malignant melanoma.Cancer science · 2019Trial
- Efficacy and safety of nivolumab in Japanese patients with previously untreated advanced melanoma: A phase II study.Cancer science · 2017Trial
- Prognosis and Toxicity Stratified by Best Tumor Burden Change in Japanese Patients With Advanced Melanoma Treated With First-Line Programmed Cell Death Protein 1 Monotherapy.The Journal of dermatology · 2025Article
- Article
- Cutaneous adverse events associated with the efficacy and benefit of immune checkpoint inhibitors: a systematic review and meta-analysis.Frontiers in oncology · 2025Article
- Efficacy and Safety of Salvage-line Nivolumab Monotherapy for Advanced Esophageal Squamous Cell Carcinoma: Comparison of 240 mg Versus 480 mg Doses.Journal of gastrointestinal cancer · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Treating advanced or recurrent melanoma remains a challenge. Cancer cells can evade the immune system by blocking T-cell activation through overexpression of the inhibitory receptor programmed death 1 (PD-1) ligands. The PD-1 inhibitor nivolumab blocks the inhibitory signal in T cells, thus overcoming the immune resistance of cancer cells. Nivolumab has shown promising anticancer activity in various cancers. We carried out a single-arm, open-label, multicenter, phase II study to investigate the efficacy and safety of nivolumab in previously untreated Japanese patients with advanced melanoma. Twenty-four patients with stage III/IV or recurrent melanoma were enrolled and received i.v. nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was overall response rate evaluated by an independent radiology review committee. The independent radiology review committee-assessed overall response rate was 34.8% (90% confidence interval, 20.8-51.9), and the overall survival rate at 18 months was 56.5% (90% confidence interval, 38.0-71.4). Treatment-related adverse events (AEs) of grade 3 or 4 only occurred in three patients (12.5%). Two patients discontinued nivolumab because of AEs, but all AEs were considered manageable by early diagnosis and appropriate treatment. Subgroup analyses showed that nivolumab was clinically beneficial and tolerable regardless of BRAF genotype, and that patients with treatment-related select AEs and with vitiligo showed tendency for better survival. In conclusion, nivolumab showed favorable efficacy and safety profiles in Japanese patients with advanced or recurrent melanoma, with or without BRAF mutations. (Trial registration no. JapicCTI-142533.).
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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.