To hear about similar clinical trials, please enter your email below
Trial Title:
Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma
NCT ID:
NCT05986331
Condition:
Melanoma (Skin)
Conditions: Official terms:
Melanoma
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
BCD-201
Description:
up to 8 treatment cycles
Arm group label:
BCD-201 group
Other name:
Pembrolizumab
Intervention type:
Drug
Intervention name:
Keytruda
Description:
up to 8 treatment cycles
Arm group label:
Keytruda
Other name:
pembrolizumab
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 and Keytruda group) at a 1:1 ratio.
The goal of this study is to compare the efficacy and safety of BCD-201 and Keytruda as
first-line therapy in subjects with unresectable, metastatic, or recurrent skin melanoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
Address:
City:
Omsk
Country:
Russian Federation
Facility:
Name:
"Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Facility:
Name:
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"
Address:
City:
Saint Petersburg
Country:
Russian Federation
Start date:
July 18, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Biocad
Agency class:
Industry
Source:
Biocad
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05986331
