Anti-PD-1 antibody therapy for epithelial skin malignancies: an investigator-initiated, open-label, single-arm, multicenter, phase II clinical trial
- Conditions
- epithelial skin malignancies (e.g. cutaneous squamous cell carcinoma, extramammary Paget's disease)
- Registration Number
- JPRN-jRCT2031190048
- Lead Sponsor
- Funakoshi Takeru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response Rate -Central Review- adopted RECIST guideline version 1.1
- Secondary Outcome Measures
Name Time Method 1.Efficacy<br> -Response Rate -Doctor judgment- adopted RECIST guideline -version 1.1- <br> -Best Overall Response Rate<br> -Progression-Free Survival<br> -Overall Survival<br> -Disease control rate<br>2.Safty<br> -Type, frequency and severity of adverse events -CTCAE ver. 4.0-