Phase II trial on Programmed death-One inhibitor plus RadioThERapy in patients with Metastatic Mucosal Melanoma

Phase 2

Recruiting

• Conditions: Melanoma

• Registration Number: JPRN-jRCT1051200028
• Lead Sponsor: omura Motoo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) Histologically proven mucosal melanoma
2) Aged 20 years old or more
3) metastatic disease
4) No previous treatment for metastatic mucosal melanoma
5) ECOG PS of 0 or 1
6) Need for measurable lesion
7) Adequate organ functions
8) Written informed consent

Exclusion Criteria

1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
2) The current radiation field do not overlap the previous radiation field.
3) Active infection requiring systemic therapy.
4) Patients with immune suppression.
5) Patients with central nerve system metastases.
6) Patients with complications of autoimmune disease, histories of chronic and recurrent autoimmune disease or other diseases which require systemic steroid therapy or immune suppressor.
7) Patients received live vaccines.
8) Pregnancy, possible pregnancy or breastfeeding.
9) Psychiatric disease.
10) Patients requiring systemic steroid medication.
11) Severe pulmonary fibrosis or emphysema.
12) Patients whom principle/sub-investigator judged ineligible to participate in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS), progression-free survival (PFS), disease control rate, response duration, best overall response, tumor diameter change rate, response rate in the radiation field, disease control rate in the radiation field, Tumor diameter change rate in the radiation field, response rate outside radiation field, disease control rate outside radiation field, tumor diameter change rate outside radiation field, adverse events.