Clinical Study of the Efficacy and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin

Sponsor
Biocad
Study ID
NCT06640530
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Advanced Melanoma
  • Melanoma (Skin)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BCD-263 — DRUG
    BCD-263 at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles
  • Opdivo — DRUG
    Opdivo at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles

Study Details

The aim of the study BCD-263-2/UNIVERSE is to demonstrate comparable efficacy and similar safety and immunogenicity profile of BCD-263 and Opdivo after repeated intravenous doses in subjects with advanced unresectable or metastatic melanoma of the skin.

Key Dates

Start date
Mar 21, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2027

Study Design

Enrollment
392 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BCD-263
    BCD-263 will be administered during main period and open-label period
  • Active Comparator: Opdivo
    Opdivo will be administered during main period

Primary Outcome Measure

Overall response rate (ORR) according to RECIST 1.1 [ Time Frame: Week 25 ]

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