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Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05739006
Recruitment Status : Active, not recruiting
First Posted : February 22, 2023
Last Update Posted : August 2, 2023
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Description
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Brief Summary:

Clinical study BCD-201-1 is a double-blind randomized study of the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of BCD-201 versus Keytruda following intravenous administration to subjects with advanced unresectable, metastatic, or recurrent melanoma and NSCLC.

The study aimed to establish the equivalence of PK and similarity of the safety, immunogenicity, and PD profiles of BCD-201 and Keytruda.


Condition or disease Intervention/treatment Phase
Melanoma Non Small Cell Lung Cancer Drug: BCD-201 Drug: Keytruda Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized Clinical Study to Evaluate the Pharmacokinetics and Safety of BCD-201 (JSC BIOCAD, Russia) and Keytruda® in Patients With Different Advanced Malignancies
Actual Study Start Date : February 8, 2021
Actual Primary Completion Date : June 21, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1
BCD-201 200 mg by intravenous infusions once every 3 weeks
 Drug: BCD-201
up to 8 treatment cycles
Other Name: pembrolizumab
Active Comparator: Group 2
Keytruda 200 mg by intravenous infusions once every 3 weeks
 Drug: Keytruda
up to 8 treatment cycles
Other Name: pembrolizumab


Outcome Measures
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Primary Outcome Measures :
  1. AUC(0-504) of pembrolizumab [ Time Frame: pre-dose to week 25, 77 timepoints ]
    area under the drug concentration-time curve in the time interval from 0 to 504 hours


Secondary Outcome Measures :
  1. AUC(0-∞) of pembrolizumab [ Time Frame: pre-dose to week 25, 77 timepoints ]
    Area under the drug concentration-time curve in the time interval from 0 to ∞

  2. Cmax [ Time Frame: pre-dose to week 25, 77 timepoints ]
    maximum concentration of pembrolizumab

  3. Tmax [ Time Frame: pre-dose to week 25, 77 timepoints ]
    time to maximum concentration of pembrolizumab

  4. T½ [ Time Frame: pre-dose to week 25, 77 timepoints ]
    Half-life period

  5. Vd [ Time Frame: pre-dose to week 25, 77 timepoints ]
    Steady-state volume of distribution of the drug substance

  6. Cmin [ Time Frame: pre-dose to week 25, 77 timepoints ]
    minimum concentration of pembrolizumab

  7. kel [ Time Frame: pre-dose to week 25, 77 timepoints ]
    Elimination rate constant

  8. Cl [ Time Frame: pre-dose to week 25, 77 timepoints ]
    Total clearance

  9. Safety assessment [ Time Frame: Day 1 to Day 169 ]
    proportion of patients with any adverse events (AEs); • proportion of patients with severe AEs; proportion of patients who discontinued study therapy due to AEs; • proportion of patients with immune-mediated AEs

  10. Immunogenicity assessment [ Time Frame: pre-dose to week 25, 5 timepoints ]
    the frequency of binding and neutralizing anti-pembrolizumab antibody production

  11. To compare the results of pilot assessment of BCD-201 and Keytruda efficacy [ Time Frame: Day 1 to week 25 ]
    overall response rate (ORR)


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:

  • Signed informed consent;
  • Body weight 60 to 90 kg;
  • Histologically confirmed melanoma or NSCLC (patients with NSCLC are eligible to participate if high tumor PD-L1 expression [≥50%] is confirmed by local or central laboratory results);
  • ECOG score 0-1;
  • Laboratory test results consistent with adequate functioning of systems and organs;
  • Willingness of males and females of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and within 6 months after the administration of the last product dose

Exclusion Criteria:

  • Indications for radical therapy (surgery, radiation therapy);
  • Previous systemic anti-tumor therapy for advanced unresectable, recurrent or metastatic melanoma or NSCLC (history of neoadjuvant or adjuvant therapy is acceptable provided that the treatment was completed at least 6 weeks prior to randomization);
  • Active metastases in the central nervous system and/or carcinomatous meningitis;
  • Patients 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;
  • For patients with NSCLC: presence of activating EGFR mutations/ALK translocations;
  • Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study;
  • Active, known or suspected autoimmune disorders (subjects with type 1 diabetes mellitus or hypothyroidism requiring only hormone-replacement therapy and those with skin disorders [vitiligo, alopecia, or psoriasis] not requiring systemic therapy are eligible to participate);
  • The need for therapy with glucocorticoids or any other drugs with immunosuppressive effects within 14 days prior to randomization;
  • History of (non-infectious) pneumonitis requiring glucocorticoid therapy or pneumonitis at the time of screening;
  • Hypersensitivity or allergy to any of the pembrolizumab product components;
  • Pregnancy or breastfeeding, as well as intention to become pregnant or father a child during the study period.
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): NCT05739006


Locations
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Russian Federation
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Moscow, Russian Federation
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
Omsk, Russian Federation
State Budgetary Healthcare Institution "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"
Saint Petersburg, Russian Federation, 197758
Sponsors and Collaborators
Biocad
More Information
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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT05739006    
Other Study ID Numbers: BCD-201-1
First Posted: February 22, 2023    Key Record Dates
Last Update Posted: August 2, 2023
Last Verified: August 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
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action