Trial reportInternational journal of clinical oncology2020
Multicenter prospective phase II trial of nivolumab in patients with unresectable or metastatic mucosal melanoma.
Trial report in International journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 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
19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Management of Uveal Melanoma: Updated Cancer Care Alberta Clinical Practice Guideline.Current oncology (Toronto, Ont.) · 2023Guideline
- Immune Checkpoint Inhibitor Associated Hepatotoxicity in Primary Liver Cancer Versus Other Cancers: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2021Pooled it
- Efficacy of Immune Checkpoint Inhibitors in Rare Tumours: A Systematic Review.Frontiers in immunology · 2021Pooled it
- Final analysis of a phase II study of nivolumab in combination with ipilimumab for unresectable chemotherapy-naive advanced melanoma.The Journal of dermatology · 2020Trial
- Article
- Phase II trial on nivolumab plus hypofractionated radiotherapy in patients with metastatic mucosal melanoma: PORTER-M3 trial.Immuno-oncology technology · 2025Article
- Immunotherapy of Human Melanoma: Past, Present, Future.Current medicinal chemistry · 2025Review
- Effectiveness of immune checkpoint inhibitors and other treatment modalities in patients with advanced mucosal melanomas: a systematic review and individual patient data meta-analysis.EClinicalMedicine · 2024Article
- Clinical Characteristics and Special Considerations in the Management of Rare Melanoma Subtypes.Cancers · 2024Review
- Multidisciplinary approach and treatment of acral and mucosal melanoma.Frontiers in oncology · 2024Review
- Advances in immunotherapy for mucosal melanoma: harnessing immune checkpoint inhibitors for improved treatment outcomes.Frontiers in immunology · 2024Review
- Molecular underpinnings of exceptional response in primary malignant melanoma of the esophagus to anti-PD-1 monotherapy.Journal for immunotherapy of cancer · 2023Article
- A case of long-term survival treated with three metastasectomies and two subsequent adjuvant nivolumab therapies for recurrent malignant melanoma of the esophagus.Surgical case reports · 2022Article
- New Therapeutic Perspectives in the Treatment of Uveal Melanoma: A Systematic Review.Biomedicines · 2021Review
- Immunotherapy in Metastatic Mucosal Melanoma with Disseminated Intravascular Coagulation: A Case of Success.Case reports in immunology · 2021Article
- Epidemiology and survival outcomes of primary gastrointestinal melanoma: a SEER-based population study.International journal of clinical oncology · 2020Article
- Article
- Metastatic melanoma: can FDG-PET predict success of anti-PD-1 therapy and help determine when it can be discontinued?European journal of nuclear medicine and molecular imaging · 2020Article
- Immune checkpoint inhibitors in advanced or metastatic mucosal melanoma: a systematic review.Therapeutic advances in medical oncology · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMucosal melanoma is a rare and aggressive malignancy with poorer response compared with cutaneous melanoma. Prospective trials of immune checkpoint inhibitors in unresectable or metastatic mucosal melanoma have not been reported. PURPOSE: This phase II trial assessed the efficacy and safety of nivolumab monotherapy for unresectable or metastatic mucosal melanoma. PATIENTS AND
methodsEligibility criteria were as follows: histological diagnosis of unresectable or metastatic mucosal melanoma; age ≥ 20 years; ECOG performance status 0 or 1; and with measurable lesions. Patients received nivolumab 2 mg/kg every 3 weeks. The primary endpoint was the response rate (RR) according to Response Evaluation Criteria in Solid Tumors version 1.1. The secondary endpoints were overall survival, progression-free survival, disease control rate, and toxicity.
resultsTwenty patients were enrolled between December 2014 and July 2017. Two patients without measurable lesions and one patient with uveal melanoma were excluded from analysis of efficacy. The best overall RR was 23.5%. One patient achieved a complete response, three partial response, and five stable disease as their best response. The median progression-free survival was 1.4 months (95% CI 1.2-2.8). The median overall survival was 12.0 months (95% CI 3.5 to not reached). The 1-year overall survival was 50.0% (95% CI 25.9-70.0%). Treatment-related adverse events of grades 3 or 4 occurred in 15% (3/20) of the patients. Grade 3 adverse events were resolved by corticosteroid treatment.
conclusionAlthough this trial met the primary endpoint, the RR was still unsatisfactory. Therefore, further treatment development is required.
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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.