臨床研究等提出・公開システム

Anti-PD-1 antibody therapy for epithelial skin malignancies: an investigator-initiated, open-label, single-arm, multicenter, expanded access program.

NMSC-EAP Study

Takeru Funakoshi

Keio University Hospital

35 Shinanomachi, Shinjuku-Ku, Tokyo

takeruf@a8.keio.jp

Takeru Funakoshi

Keio University Hospital

35 Shinanomachi, Shinjuku-Ku, Tokyo

+81-3-5363-3823

nmsc-eap_office-group@keio.jp

Complete

April. 17, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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)

Both

Epithelial skin malignancy

AdministerONO-4538 480mg intravenously over 30 minutes or more (with a guideline of within 1 hour) at 4-week intervals.

Type, frequency and severity of adverse events(CTCAE ver. 5.0)

+81-3-5363-3848

Mar. 06, 2023

No

none