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Advanced MelanomaPhase 1NCT06112808

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

A Phase 1 study testing BCD-263 and Opdivo in people with Advanced Melanoma, run by Biocad at 30 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Melanoma
What is being tested?
BCD-263 and Opdivo
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
30 sitesin 2 countries
Study dates
29 May 2023to Jan 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

30 sites in 2 countries.

30 sites in 2 countries

Russia28 sites

  • State Budgetary Institution of Healthcare of the Arkhangelsk Region "Severodvinsk City Hospital №2 of Emergency"

    Arkhangelsk, 164523

  • Regional State Budgetary Healthcare Institution "Altai Regional Oncological Dispensary"

    Barnaul, 656045

  • Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Federal State Educational Institution of Higher Education "Baltic Federal University Named after Immanuel Kant"

    Kaliningrad, 236016

  • Limited Liability Company "Ars Medica Centre"

    Kaliningrad, 236022

  • State Budgetary Healthcare Institution of Kaluga Region "Kaluga Region Clinical Oncological Dispensary"

    Kaluga, 248007

  • 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'

  • Regional State Budgetary of Healthcare Insti-tution "Kostroma Clinical Oncology Dispensary"

    Kostroma, 156005

  • "Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation

    Moscow, 115478

  • JSC "Medsi Group"

    Moscow

  • Moscow City Oncology Hospital No. 62

    Moscow

  • 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

  • State Budgetary Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD)

    Moscow

  • Nizhny Novgorod Region State Budgetary Healthcare Institution "Nizhny Novgorod Regional Clinical Oncological Dispensary"

    Nizhny Novgorod, 603126

  • State Budgetary Healthcare Institution of Novosibirsk Region "Novosibirsk Region Clinical Oncological Dispensary"

    Novosibirsk, 630108

  • State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

    Omsk

  • LLC "New Clinic"

    Pyatigorsk, Stavropol Kray, 357500

  • JSC "Modern Medical Technologies"

    Saint Petersburg, Sankt-Peterburg, 190013

  • Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of Saint Petersburg"

    Saint Petersburg, 195271

  • "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"

    Saint Petersburg

  • Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation

    Saint Petersburg

  • Limited Liability Company "Oncological Research Center"

    Saint Petersburg

  • Private Medical Institution Evromedservis

    Saint Petersburg

  • State-financed Health Institution "Samara Region Clinical Oncology Dispensary"

    Samara, 443031

  • Federal State Educational Institution of Higher Professional Education "Mordovia State University N.P. Ogareva "

    Saransk

  • Limited Liability Company "Nebbiolo"

    Tomsk, 634009

  • Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan

    Ufa, 450054

  • State Health Care Institution "Volgograd Regional Clinical Oncology Dispensary № 1"

    Volgograd

Other trials in Russia

Belarus2 sites

  • Healthcare Institution "Minsk City Clinical Cancer Center"

    Minsk, 220013

  • State Institution "Republic Scientific and Practical Centre for Oncology and Medical Radiology Named after N.N.Aleksandrov"

    Minsk, 223040

Other trials in Belarus

About this study

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

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.

Read the detailed description

Following screening, subjects will be randomized to receive either BCD-263 or Opdivo in a 1:1 ratio and enter the main study period.

During the main study period, subjects will receive therapy with BCD-263 or Opdivo, which will be administered intravenously until disease progression or signs of unacceptable toxicity develop (whichever occurs earlier).

At Week 25, after completion of all scheduled procedures subjects in both groups will continue to receive open-label BCD-263 for up to a total of 2 years of therapy, or disease progression, or signs of unacceptable toxicity (whichever occurs first).

Following discontinuation of the study therapy, the subjects will enter a follow-up period, during which data on overall survival will be collected through telephone contacts.

Being tested
BCD-263, Opdivo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-263Drug

    Also called Nivolumab

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

  • OpdivoDrug

    Also called Nivolumab

    Opdivo at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles

Study groups in NCT06112808
Study groupRoleWhat they receive
BCD-263ExperimentalNot described
Receives: Drug: BCD-263
OpdivoActive comparatorNot described
Receives: Drug: Opdivo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC(0-672) of nivolumab

    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

    Measured: pre-dose to week 25

Secondary outcomes (18)

  1. Cmax

    To compare the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo

    Measured: week 25

  2. AUC(0-∞)

    To compare area under the drug concentration-time curve in the time interval from 0 to ∞ after intravenous administration of BCD-263 and Opdivo

    Measured: week 25

  3. Tmax

    To compare time to the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo

    Measured: week 25

  4. T½

    To compare half-life period of nivolumab after intravenous administration of BCD-263 and Opdivo

    Measured: week 25

  5. Kel

    To compare elimination rate constant of nivolumab after intravenous administration of BCD-263 and Opdivo

    Measured: week 25

  6. Vd

    To compare steady-state volume of distribution of nivolumab after intravenous administration of BCD-263 and Opdivo

    Measured: week 25

  7. Cl

    To compare total clearance of nivolumab after intravenous administration of BCD-263 and Opdivo

    Measured: week 25

  8. Ceoi

    To compare plasma concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo

    Measured: week 25

  9. Ctrough

    To compare trough concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo

    Measured: week 25

  10. Safety assessment

    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

    Measured: week 25

  11. Immunogenicity assessment

    Proportion of subjects with binding and/or neutralizing antibodies to nivolumab

    Measured: week 25

  12. Pharmacodynamics assessment

    Occupancy of PD-1 receptors on CD4+ and CD8+ peripheral blood lymphocytes

    Measured: week 25

  13. Efficacy assessment: ORR

    To compare overall response rate according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

  14. Efficacy assessment: PFS

    To compare progression-free survival according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

  15. Efficacy assessment: overall survival

    To compare overall survival according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

  16. Efficacy assessment: DCR

    To compare disease control rate according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

  17. Efficacy assessment: time to response

    To compare time to response according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

  18. Efficacy assessment: duration of response

    To compare duration of response according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo

    Measured: week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start29 May 2023
  3. Primary completion31 Jan 2024
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06112808
Sponsor's protocol ID
BCD-263-1
Status last verified
Jul 2025
First submitted
27 Oct 2023
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCD-263 and Opdivo in people with Advanced Melanoma, run by Biocad at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Russia, Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC(0-672) of nivolumab (time frame: pre-dose to week 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06112808.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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