Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

1537 - Phase II trial on nivolumab in patients with unresectable or metastatic mucosal melanoma.

Date

21 Oct 2018

Session

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

Presenters

Motoo Nomura

Citation

Annals of Oncology (2018) 29 (suppl_8): viii442-viii466. 10.1093/annonc/mdy289

Authors

M. Nomura1, M. Andoh2, T. Yokota3, T. Miyazaki4, H. Satake5, S. Iwasawa6, A. Sonoda7, K. Kato8, M. Muto1

Author affiliations

  • 1 Medical Oncology, Kyoto University-Graduate school of medicine, 606-8507 - Kyoto/JP
  • 2 Clinical Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 3 Gastrointestinal Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 4 Head And Neck Surgery, Kurashiki Central Hospital, Kurashiki/JP
  • 5 Medical Oncology, Kobe City Medical Center General Hospital, 650-0047 - Kobe/JP
  • 6 Respirology, Chiba University Graduate School of Medicine, Chiba/JP
  • 7 Gastroenterology, Shiga University of Medical Science, Otsu/JP
  • 8 Gastrointestinal Medical Oncology, National Cancer Center Hospital, 104-0045 - Tokyo/JP
More

Resources

Abstract 1537

Background

Mucosal melanoma is rare and an aggressive malignancy with poor response compared with cutaneous melanoma. The prospective trial on immune-checkpoint inhibitors in unresectable or metastatic mucosal melanoma has not been reported except pooled analysis. The aim of this phase II trial was to assess the efficacy and safety of nivolumab monotherapy for unresectable or metastatic mucosal melanoma.

Methods

Eligibility 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 response rate (RR) according to Response Evaluation Criteria in Solid Tumors version 1.1(≧ 20%). The secondary endpoints were overall survival, progression-free survival, disease control rate, and toxicity.

Results

A total of 20 patients were enrolled between December 2014 and July 2017. Two patients without measurable lesion were excluded from analysis of efficacy. The RR was 22%, suggesting that the primary endpoint was met. One patient achieved a complete response, three patients achieved partial response, and six patients achieved stable disease as their best response. The median progression-free survival was 1.4 months (95% CI, 1.15 to 5.47). The median overall survival was 12.03 months (95% CI, 3.50 to not reach). The 1-year overall survival data was 52.6% (95% CI, 28.5 to 72.0). Treatment-related adverse events of grade 3 or 4 occurred in 15% (3/20) of the patients. Grade 3 diarrhea was observed in two patients and grade 3 adrenal insufficiency was observed in one patient. They were resolved by corticosteroid.

Conclusions

Although this trial met the primary endpoint, the RR was still unsatisfactory. Therefore, the further treatment development is required.

Clinical trial identification

UMIN000015845.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.