A Clinical Study of the Pharmacokinetics and Safety of BCD-263 and Opdivo® as Monotherapy in Subjects With Advanced Melanoma of the Skin
- 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.
- 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
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-01-01
- First posted
- 2023-11-02
- Registry last updated
- 2025-07-08
- Primary completion date
- 2024-01-31
- Start date
- 2023-05-29
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Biocad
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06112808
- ClinicalTrials.gov ID
- NCT06112808
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
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
Cmax
Timeframe: week 25
To compare the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo
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
Tmax
Timeframe: week 25
To compare time to the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo
T½
Timeframe: week 25
To compare half-life period of nivolumab after intravenous administration of BCD-263 and Opdivo
Kel
Timeframe: week 25
To compare elimination rate constant of nivolumab after intravenous administration of BCD-263 and Opdivo
Vd
Timeframe: week 25
To compare steady-state volume of distribution of nivolumab after intravenous administration of BCD-263 and Opdivo
Cl
Timeframe: week 25
To compare total clearance of nivolumab after intravenous administration of BCD-263 and Opdivo
Ceoi
Timeframe: week 25
To compare plasma concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo
Ctrough
Timeframe: week 25
To compare trough concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo
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
Immunogenicity assessment
Timeframe: week 25
Proportion of subjects with binding and/or neutralizing antibodies to nivolumab
Pharmacodynamics assessment
Timeframe: week 25
Occupancy of PD-1 receptors on CD4+ and CD8+ peripheral blood lymphocytes
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
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
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
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
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
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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
-
Age ≥18 years at the time of signing the informed consent form;
-
Body weight 60 to 90 kg.
-
Histologically confirmed melanoma with the following prognostic characteristics:
- LDH <ULN of local laboratory (enrollment of subjects with LDH <2x ULN of local laboratory is allowed until the number of subjects with LDH >ULN is 30% of the total population of randomized subjects. The Sponsor will inform when enrollment of subjects is limited by LDH level <ULN of the local laboratory).
- Absence, according to the Investigator, of clinically significant symptoms associated with the tumor.
- Absence, according to the Investigator, of rapidly progressing metastatic melanoma.
-
Newly diagnosed advanced unresectable (stage III) or metastatic disease (stage IV), or progressive disease during / relapsing after radical treatment.
- Indications for radical treatment (surgery, radiation therapy).
- Uveal or mucosal melanoma.
- Previous systemic anticancer therapy for advanced unresectable or metastatic skin melanoma (a history of neoadjuvant or adjuvant therapy is allowed, provided that the therapy was completed at least 12 weeks before randomization).
- Active CNS metastases and/or carcinomatous meningitis.
- Previous invasive cancer, excluding diseases treated with potentially curative therapy with no evidence of recurrence for 2 years from the start of this therapy (subjects with radically resected basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical carcinoma in situ of the uterus and other carcinomas in situ may be included).
- Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis, bleeding or organ perforation) at the time of signing the informed consent and during the screening period.
- Concomitant diseases and/or conditions that significantly increase the risk of adverse events (AEs) during the study.
- Healthcare Institution "Minsk City Clinical Cancer Center"Minsk, Belarus
- State Institution "Republic Scientific and Practical Centre for Oncology and Medical Radiology Named after N.N.Aleksandrov"Minsk, Belarus
- Chelyabinsk Regional Clinical Center for Oncology and Nuclear MedicineChelyabinsk, Russia
- JSC "Modern Medical Technologies"Saint Petersburg, Russia
- LLC "New Clinic"Pyatigorsk, Russia
- State Budgetary Institution of Healthcare of the Arkhangelsk Region "Severodvinsk City Hospital №2 of Emergency"Arkhangelsk, Russia
- Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"Barnaul, Russia
- Federal State Educational Institution of Higher Education "Baltic Federal University Named after Immanuel Kant"Kaliningrad, Russia
- Limited Liability Company "Ars Medica Centre"Kaliningrad, Russia
- State Budgetary Healthcare Institution of Kaluga Region "Kaluga Region Clinical Oncological Dispensary"Kaluga, Russia
- State Autonomous Health Institution "Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Tatarstan named after Professor M.Z. Sigal"Kazan', Russia
- Regional State Budgetary of Healthcare Insti-tution "Kostroma Clinical Oncology Dispensary"Kostroma, Russia
- "Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian FederationMoscow, Russia
- JSC "Medsi Group"Moscow, Russia
- Moscow City Oncology Hospital No. 62Moscow, Russia
- State budgetary health care institution of the city of Moscow "City Clinical Oncology Hospital No. 1 of the Department of Health of the City of Moscow"Moscow, Russia
- State Budgetary Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD)Moscow, Russia
- Nizhny Novgorod Region State Budgetary Healthcare Institution "Nizhny Novgorod Regional Clinical Oncological Dispensary"Nizhny Novgorod, Russia
- State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Region Clinical Oncological Dispensary"Novosibirsk, Russia
- State budget healthcare institution Omsk region "Clinical Oncology Dispensary"Omsk, Russia
- Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Saint Petersburg"Saint Petersburg, Russia
- "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"Saint Petersburg, Russia
- Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian FederationSaint Petersburg, Russia
- Limited Liability Company "Oncological Research Center"Saint Petersburg, Russia
- Private Medical Institution EvromedservisSaint Petersburg, Russia
And 5 more, listed on the interactive page.
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Melanoma Primary condition