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

JRCT ID: jRCT1051200028

Registered date:22/06/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Melanoma
• Date of first enrollment: 11/07/2018
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Nivolumab+Radiotherapy

Outcome(s)

• Primary Outcome: Response rate
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Nomura Motoo
• Secondary ID(s): UMIN000030533