epithelial skin malignancies (e.g. cutaneous squamous cell carcinoma, extramammary Paget's disease)
Conditions
Interventions
Sponsors
Funakoshi Takeru
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 one or more measurable lesions defined in RECIST Guideline Version 1.1 (except for the primary lesion) and who have received radiation therapy for measurable lesions within 14 days prior to enrollment in this clinical trial, Patients whose progress has been confirmed in clinical findings or imaging diagnosis after radiation therapy) 4)Patients with ECOG PS 0-1
Exclusion criteria
Exclusion criteria: 1) Patients who have merged or have a high degree of hypersensitivity to other antibody preparations 2) Patients whose adverse reactions or adverse effects of surgical treatment remain and the investigator or sub-investigator has judged that the safety evaluation of the investigational drug will be affected 3) Patients with a combination of autoimmune diseases or a history of chronic or recurrent autoimmune diseases. However, patients with hypothyroidism that can be treated by hormone replacement therapy or skin diseases that do not require systemic therapy (white spots, psoriasis, alopecia, etc.) can be registered. 4) Patients with double cancer (completely resected basal cell carcinoma, carcinoma in situ, carcinoma in situ, or superficial bladder cancer, or patients with other cancers that do not show recurrence for more than 5 years before obtaining consent) 5) Patients with central nervous system metastasis. However, patients who are asymptomatic and do not need treatment can be registered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate -Central Review- adopted RECIST guideline version 1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Efficacy -Response Rate -Doctor judgment- adopted RECIST guideline -version 1.1- -Best Overall Response Rate -Progression-Free Survival -Overall Survival -Disease control rate 2.Safty -Type, frequency and severity of adverse events -CTCAE ver. 4.0- | — |
Contacts
Public ContactYasuko Saito
Keio University Hospital
Outcome results
None listed