Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Biocad
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed informed consent;
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;
ECOG score 0-1;
At least one measurable lesion according to RECIST 1.1;
Laboratory test results consistent with adequate functioning of systems and organs;
Willingness of men and women of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and for 6 months after the administration of the last product dose.
You may not be if
Indications for radical therapy (surgery, radiation therapy);
Uveal, ocular or mucosal melanoma;
Active CNS metastases and/or carcinomatous meningitis;
Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease;
Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study;
Active, known or suspected autoimmune disorders (subjects with type 1 diabetes mellitus or hypothyroidism requiring only hormone-replacement therapy and those with skin disorders \[vitiligo, alopecia, or psoriasis\] not requiring systemic therapy are eligible to participate);
The need for therapy with glucocorticoids or any other drugs with immunosuppressive effects within 14 days prior to randomization;
History of (non-infectious) pneumonitis requiring glucocorticoid therapy or pneumonitis at the time of screening;
Hypersensitivity or allergy to any of the pembrolizumab product components;
Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.
Clareo Health | Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma
