Trial reportCancer science2019
Long-term follow up of nivolumab in previously untreated Japanese patients with advanced or recurrent malignant melanoma.
Trial report in Cancer science, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 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
27 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Immune Checkpoint Inhibitor Associated Hepatotoxicity in Primary Liver Cancer Versus Other Cancers: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2021Pooled it
- Immune Checkpoint Inhibitors in Advanced Acral Melanoma: A Systematic Review.Frontiers in oncology · 2020Pooled it
- Nivolumab in previously treated advanced gastric cancer (ATTRACTION-2): 3-year update and outcome of treatment beyond progression with nivolumab.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2021Trial
- Five-year survival with nivolumab in previously untreated Japanese patients with advanced or recurrent malignant melanoma.The Journal of dermatology · 2021Trial
- Trial
- Long-term follow up of nivolumab in previously untreated Japanese patients with advanced or recurrent malignant melanoma.Cancer science · 2019Trial
- Immunotherapy of Human Melanoma: Past, Present, Future.Current medicinal chemistry · 2025Review
- Genetic Characteristics of Cutaneous, Acral, and Mucosal Melanoma in Japan.Cancer medicine · 2024Article
- Cutaneous Adverse Reactions and Survival Outcomes of Advanced Melanoma Treated with Immune Checkpoint Inhibitors in an Academic Medical Centre in Singapore.Diagnostics (Basel, Switzerland) · 2024Article
- Long-term follow-up results from KEYNOTE-041: Phase 1b study of pembrolizumab in Japanese patients with advanced melanoma.The Journal of dermatology · 2024Article
- Optimal strategy in managing advanced melanoma.The Journal of dermatology · 2024Review
- Article
- Dermatological Autoimmune Considerations of Immune Checkpoint Therapy.Biomedicines · 2022Article
- Safety and efficacy of nivolumab compared with other regimens in patients with melanoma: A network meta-analysis.Medicine · 2022Article
- A phase I study of the safety and efficacy of talimogene laherparepvec in Japanese patients with advanced melanoma.Cancer science · 2022Article
- Pembrolizumab in Chinese patients with advanced melanoma: 3-year follow-up of the KEYNOTE-151 study.Frontiers in immunology · 2022Article
- A case of primary malignant melanoma of the esophagogastric junction with abscopal effect after nivolumab administration.Surgical case reports · 2021Article
- A phase I/II study of rovalpituzumab tesirine in delta-like 3-expressing advanced solid tumors.NPJ precision oncology · 2021Article
- Effectiveness and safety of nivolumab in patients with head and neck cancer in Japanese real-world clinical practice: a multicenter retrospective clinical study.International journal of clinical oncology · 2021Article
- Emerging strategies to treat rare and intractable subtypes of melanoma.Pigment cell & melanoma research · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
The immune checkpoint inhibitor nivolumab inhibits the programmed death 1 receptor and suppresses the immune resistance of cancer cells. This is a long-term follow up of a single-arm, open-label, multicenter, phase II study of nivolumab in untreated Japanese patients with stage III/IV or recurrent melanoma. In addition, a post-hoc subgroup analysis stratified by melanoma types was performed. Nivolumab was administered intravenously at a dose of 3 mg/kg every 2 weeks. The primary endpoint was the overall response rate (ORR), and secondary endpoints included overall survival (OS), progression-free survival (PFS), best overall response, the disease control rate and change in tumor diameter. Safety was assessed by recording treatment-related adverse events (TRAE), including select immune-related adverse events. Of the 24 patients initially included in the primary phase II study, 10 survived for over 3 years (41.7%). The ORR was 34.8% (90% confidence interval [CI]: 20.8, 51.9) for all patients. When analyzing by melanoma type, the ORR was 66.7% (90% CI: 34.7, 88.3) for superficial spreading, 33.3% (90% CI: 11.7, 65.3) for mucosal, and 28.6% (90% CI: 10.0, 59.1) for acral lentiginous tumors. The median OS was 32.9 months, the 3-year OS rate was 43.5%, and the 3-year PFS rate was 17.2%. A long-term response was observed in all the tumor types. The most common TRAE included skin toxicity (45.8%) and endocrine disorders (29.2%). This study demonstrated the long-term efficacy and tolerability of nivolumab in patients with advanced or recurrent melanoma, irrespective of melanoma type.
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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.