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

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ClinicalTrials.gov Identifier: NCT06112808
Recruitment Status : Recruiting
First Posted : November 2, 2023
Last Update Posted : November 3, 2023
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Melanoma Drug: BCD-263 Drug: Opdivo Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 29, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: BCD-263 Drug: BCD-263
BCD-263 at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles
Other Name: Nivolumab
Active Comparator: Opdivo Drug: Opdivo
Opdivo at a dose 480 mg administered intravenously every 4 weeks up to 6 cycles
Other Name: Nivolumab


Outcome Measures
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Primary Outcome Measures :
  1. AUC(0-672) of nivolumab [ Time Frame: 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 Outcome Measures :
  1. Cmax [ Time Frame: week 25 ]
    To compare the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo

  2. AUC(0-∞) [ Time Frame: 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 [ Time Frame: week 25 ]
    To compare time to the maximum concentration of nivolumab after intravenous administration of BCD-263 and Opdivo

  4. T½ [ Time Frame: week 25 ]
    To compare half-life period of nivolumab after intravenous administration of BCD-263 and Opdivo

  5. Kel [ Time Frame: week 25 ]
    To compare elimination rate constant of nivolumab after intravenous administration of BCD-263 and Opdivo

  6. Vd [ Time Frame: week 25 ]
    To compare steady-state volume of distribution of nivolumab after intravenous administration of BCD-263 and Opdivo

  7. Cl [ Time Frame: week 25 ]
    To compare total clearance of nivolumab after intravenous administration of BCD-263 and Opdivo

  8. Ceoi [ Time Frame: week 25 ]
    To compare plasma concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo

  9. Ctrough [ Time Frame: week 25 ]
    To compare trough concentration at the and of infusion of nivolumab after intravenous administration of BCD-263 and Opdivo

  10. Safety assessment [ Time Frame: 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 [ Time Frame: week 25 ]
    Proportion of subjects with binding and/or neutralizing antibodies to nivolumab

  12. Pharmacodynamics assessment [ Time Frame: week 25 ]
    Occupancy of PD-1 receptors on CD4+ and CD8+ peripheral blood lymphocytes

  13. Efficacy assessment: ORR [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: week 25 ]
    To compare duration of response according to RECIST 1.1 and iRECIST criteria after administration of BCD-263 or Opdivo


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.
  4. Newly diagnosed advanced unresectable (stage III) or metastatic disease (stage IV), or progressive disease during / relapsing after radical treatment.

Exclusion Criteria:

  1. Indications for radical treatment (surgery, radiation therapy).
  2. Uveal or mucosal melanoma.
  3. 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).
  4. Active CNS metastases and/or carcinomatous meningitis.
  5. 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).
  6. 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.
  7. Concomitant diseases and/or conditions that significantly increase the risk of adverse events (AEs) during the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06112808


Contacts
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Contact: Anton Lutckii, MD PhD +7 (812) 380 49 33 ext 6768 lutskii@biocad.ru

Locations
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Sponsors and Collaborators
Biocad
Investigators
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Study Director: Arina V Zinkina-Orikhan Director of Clinical Development Department, BIOCAD
More Information
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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT06112808    
Other Study ID Numbers: BCD-263-1
First Posted: November 2, 2023    Key Record Dates
Last Update Posted: November 3, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Melanoma
Melanoma, Cutaneous Malignant
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
 Skin Neoplasms
Neoplasms by Site
Skin Diseases
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action