Phase II trial on nivolumab plus hypofractionated radiotherapy in patients with metastatic mucosal melanoma: PORTER-M3 trial.

ABSTRACT:

Background

The response rate of nivolumab monotherapy for mucosal melanoma is only ∼20%. The objective of this phase II trial was to evaluate the efficacy and safety of nivolumab in combination with radiotherapy for metastatic mucosal melanoma.

Patients and methods

The eligibility criteria were: histological diagnosis of metastatic mucosal melanoma, Eastern Cooperative Oncology Group performance status of 0 or 1, and presence of measurable lesions. Patients received nivolumab with concurrent radiotherapy for measurable lesions, for a total dose of 25 Gy in five fractions per week. The primary endpoint was the response rate of all lesions (overall response rate, ORR). The study was considered to have met its primary endpoint if at least 6 of the 17 patients had a response (OR

SUBMITTER: Nomura M 

PROVIDER: S-EPMC12752525 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature