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

• ClinicalTrials.gov Identifier: NCT05739006
• Recruitment Status: Active, not recruiting
• First Posted: February 22, 2023
• Last Update Posted: August 2, 2023
• Sponsor: Biocad
• Information provided by (Responsible Party): Biocad

Tracking Information

• First Submitted Date: February 13, 2023
• First Posted Date: February 22, 2023
• Last Update Posted Date: August 2, 2023
• Actual Study Start Date: February 8, 2021
• Actual Primary Completion Date: June 21, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 13, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 13, 2023)

• 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 ∞
• Cmax [ Time Frame: pre-dose to week 25, 77 timepoints ]
  maximum concentration of pembrolizumab
• Tmax [ Time Frame: pre-dose to week 25, 77 timepoints ]
  time to maximum concentration of pembrolizumab
• T½ [ Time Frame: pre-dose to week 25, 77 timepoints ]
  Half-life period
• Vd [ Time Frame: pre-dose to week 25, 77 timepoints ]
  Steady-state volume of distribution of the drug substance
• Cmin [ Time Frame: pre-dose to week 25, 77 timepoints ]
  minimum concentration of pembrolizumab
• kel [ Time Frame: pre-dose to week 25, 77 timepoints ]
  Elimination rate constant
• Cl [ Time Frame: pre-dose to week 25, 77 timepoints ]
  Total clearance
• 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
• Immunogenicity assessment [ Time Frame: pre-dose to week 25, 5 timepoints ]
  the frequency of binding and neutralizing anti-pembrolizumab antibody production
• To compare the results of pilot assessment of BCD-201 and Keytruda efficacy [ Time Frame: Day 1 to week 25 ]
  overall response rate (ORR)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Melanoma
• Non Small Cell Lung Cancer

Intervention

• Drug: BCD-201
  up to 8 treatment cycles
  Other Name: pembrolizumab
• Drug: Keytruda
  up to 8 treatment cycles
  Other Name: pembrolizumab

Study Arms

• Experimental: Group 1
  BCD-201 200 mg by intravenous infusions once every 3 weeks
  Intervention: Drug: BCD-201
• Active Comparator: Group 2
  Keytruda 200 mg by intravenous infusions once every 3 weeks
  Intervention: Drug: Keytruda

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: February 13, 2023): 131
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: August 31, 2023
• Actual Primary Completion Date: June 21, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Russian Federation

Administrative Information

• NCT Number: NCT05739006
• Other Study ID Numbers: BCD-201-1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Biocad
• Original Responsible Party: Same as current
• Current Study Sponsor: Biocad
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Biocad
• Verification Date: August 2023