A Randomized, Double-Blind Clinical Study of the Efficacyand Safety of BCD-201 (JSC BIOCAD) and Keytruda® inPatients with Unresectable or Metastatic Melanoma

JSC BIOCAD0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年9月18日

试验速览

暂无简介。

•Age =18 years at the signing of the informed consent form.
•Histologically confirmed melanoma.
•Tumor first detected at the stage of advanced unresectable or metastatic disease, or disease
•progressing during or recurring after previous radical therapy.
•At least one measurable lesion according to RECIST 1.1 based on central review.
•ECOG score 0–1.

•Indications for radical therapy (surgery, radiation therapy).
•Uveal melanoma or mucosal melanoma.
•Previous systemic anti-tumor therapy for advanced unresectable, recurrent or metastatic skin
•melanoma (history of neoadjuvant or adjuvant therapy is acceptable provided that the treatment
•was completed at least 6 weeks prior to randomization).
•Active CNS metastases and/or carcinomatous meningitis. Subjects with brain metastases are
•eligible to participate provided that the metastases have been adequately treated with surgery
•or radiation therapy only and are stable based on the results of imaging assessments.
•Previous invasive malignancy with any evidence of the disease within the last 3 years.
•Participants with non-melanoma skin cancer or carcinoma in situ (e.g., breast cancer) who have
•undergone radical therapy are not excluded.

发起方

JSC BIOCAD