> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-of-the-pharmacokinetics-and-safety-of-bcd-da66e0e5-360c-4d82-a308-3ebaaa5ec28f > Record changed: 2026-10-13 # A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin NCT06112808 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) Lead sponsor Biocad Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) Start date 2023-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) Number of sites 30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) ## Title and summary **Summary** The aim of the study BCD-263-1 is to prove the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-263 and Opdivo following intravenous administration to subjects with advanced unresectable or metastatic melanoma of the skin. The study will have randomized, double-blind design with parallel assignment. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Short title** A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Official title** A Double-Blind, Randomized Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) ## Dates **Completion date** 2027-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **First posted** 2023-11-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Registry last updated** 2025-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Primary completion date** 2024-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Start date** 2023-05-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Randomisation ratio** 1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Number of sites** 30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Lead sponsor** Biocad Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) ## Identifiers **Registry ID** NCT06112808 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **ClinicalTrials.gov ID** NCT06112808 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) ## Outcomes ### Primary outcomes 1. AUC(0-672) of nivolumab Timeframe: pre-dose to week 25 To compare area under the drug concentration-time curve in the time interval from 0 to 672 hours after intravenous administration of BCD-263 and Opdivo ### Secondary outcomes 1. Cmax Timeframe: week 25 To compare the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo 2. AUC(0-∞) Timeframe: week 25 To compare area under the drug concentration-time curve in the time interval from 0 to ∞ after intravenous administration of BCD-263 and Opdivo 3. Tmax Timeframe: week 25 To compare time to the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo 4. T½ Timeframe: week 25 To compare half-life period of nivolumab after intravenous administration of BCD-263 and Opdivo 5. Kel Timeframe: week 25 To compare elimination rate constant of nivolumab after intravenous administration of BCD-263 and Opdivo 6. Vd Timeframe: week 25 To compare steady-state volume of distribution of nivolumab after intravenous administration of BCD-263 and Opdivo 7. Cl Timeframe: week 25 To compare total clearance of nivolumab after intravenous administration of BCD-263 and Opdivo 8. Ceoi Timeframe: week 25 To compare plasma concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo 9. Ctrough Timeframe: week 25 To compare trough concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo 10. Safety assessment Timeframe: week 25 The subjects will undergo the vital sign assessment, physical and instrumental examination, sampling for complete blood count, blood chemistry, thyroid hormone tests, and urinalysis, as well as assessment of the presence and characteristics of adverse events to assess the safety of the investigational product 11. Immunogenicity assessment Timeframe: week 25 Proportion of subjects with binding and/or neutralizing antibodies to nivolumab 12. Pharmacodynamics assessment Timeframe: week 25 Occupancy of PD-1 receptors on CD4+ and CD8+ peripheral blood lymphocytes 13. Efficacy assessment: ORR Timeframe: week 25 To compare overall response rate according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo 14. Efficacy assessment: PFS Timeframe: week 25 To compare progression-free survival according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo 15. Efficacy assessment: overall survival Timeframe: week 25 To compare overall survival according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo 16. Efficacy assessment: DCR Timeframe: week 25 To compare disease control rate according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo 17. Efficacy assessment: time to response Timeframe: week 25 To compare time to response according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo 18. Efficacy assessment: duration of response Timeframe: week 25 To compare duration of response according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06112808) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Age ≥18 years at the time of signing the informed consent form; 2. Body weight 60 to 90 kg. 3. Histologically confirmed melanoma with the following prognostic characteristics: - LDH ULN is 30% of the total population of randomized subjects. The Sponsor will inform when enrollment of subjects is limited by LDH level