Status:
UNKNOWN
Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma
Lead Sponsor:
Biocad
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This clinical study is designed as a randomized, double-blind trial. Subjects with unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two study groups (BCD-201 group...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT05986331
Start Date
July 18 2022
End Date
December 31 2024
Last Update
September 21 2023
Active Locations (3)
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1
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
Omsk, Russia
2
"Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"
Saint Petersburg, Russia
3
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"
Saint Petersburg, Russia