Carbon-ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck

Prospective observational study of the efficacy and safety of carbon-ion radiotherapy followed by Nivolumab for primary mucosal malignant melanoma of the head and neck - iROCK-2001HN

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042226

Enrollment

Registered

2020-10-26

Start date

2020-10-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mucosal malignant melanoma of the head and neck

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically confirmed mucosal malignant melanoma of the head and neck 2)Patients where radical carbon-ion radiotherapy is possible 3)Eastern Cooperative Oncology Group (ECOG) performance status 0 -2 4)Patients aged 20 years or older at the time of consent 5)Measurable disease, according to RECIST version 1.1 6)Life expectancy of greater than 12 weeks in the opinion of the investigator 7)Ability to understand and the willingness to sign written informed consent documents

Exclusion criteria

Exclusion criteria: 1)Patients with interstitial pneumonia, drug-induced interstitial lung disease or clinically active interstitial lung disease on chest CT scan 2)Patients with autoimmune disorders 3)Known allergy to compounds of similar chemical or biologic composition to Nivolumab 4)Pregnant or lactating females 5)Patients in which the physician decides that participation in the study is unsuitable

Design outcomes

Primary

Measure	Time frame
One-year progression-free survival after Nivolumab	—

Countries

Japan

Contacts

Public ContactNobutaka Mizoguchi

Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization Department of Radiation Oncology

mizoguchin@kcch.jp045-520-2222

Outcome results