Multicenter prospective phase II trial of nivolumab in patients with unresectable or metastatic mucosal melanoma.
Int J Clin Oncol
; 25(5): 972-977, 2020 May.
Article
in En
| MEDLINE
| ID: mdl-31938955
ABSTRACT
BACKGROUND:
Mucosal 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 ANDMETHODS:
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 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.RESULTS:
Twenty 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.CONCLUSION:
Although this trial met the primary endpoint, the RR was still unsatisfactory. Therefore, further treatment development is required.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Skin Neoplasms
/
Antineoplastic Agents, Immunological
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Nivolumab
/
Melanoma
Type of study:
Clinical_trials
/
Observational_studies
Limits:
Adult
/
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Int J Clin Oncol
Journal subject:
NEOPLASIAS
Year:
2020
Document type:
Article
Affiliation country:
Japan