Epithelial skin malignancy
Conditions
Interventions
AdministerONO-4538 480mg intravenously over 30 minutes or more (with a guideline of within 1 hour) at 4-week intervals.
Sponsors
Takeru Funakoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 20 years or older 2) Patients who are incurable by surgical treatment and radiation treatment, and who have been confirmed by histology to have advanced or recurrent epithelial skin malignancies 3) Patients who have more than one of measurable lesions or immeasurable lesion as defined in RECIST Guideline Version 1.1 within 14 days prior to enrollment in this clinical trial 4) Patients with ECOG PS 0-1
Exclusion criteria
Exclusion criteria: 1) Patients who have high degree of hypersensitivity or medical history of the other antibody product 2) Patients who judged by principal investigator or sub-investigator to influence the drug safety evaluation, because of who have been remained side effects of previous treatment or the impact of the surgery 3) Patients who have been merged the autoimmune disease or who have medical history of the autoimmune disease (chronic or recurrent) 4) Patients who have cancer duplication (However, patients who have been completely resected carcinoma (basal cell, epithelial, mucosal or superficial bladder) or patients who have other carcinoma that don't show recurrence more than five years before obtaining consent are can be registered) 5) Patients who have central nervous system metastasis (However, patients who are asymptomatic and do not need treatment can be registered)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, frequency and severity of adverse events(CTCAE ver. 5.0) | — |
Contacts
Public ContactFunakoshi Takeru
Keio University Hospital
Outcome results
None listed