Trials / Unknown
UnknownNCT05739006
Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 131 (actual)
- Sponsor
- Biocad · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BCD-201 | up to 8 treatment cycles |
| DRUG | Keytruda | up to 8 treatment cycles |
Timeline
- Start date
- 2021-02-08
- Primary completion
- 2022-06-21
- Completion
- 2023-08-31
- First posted
- 2023-02-22
- Last updated
- 2023-08-02
Locations
3 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05739006. Inclusion in this directory is not an endorsement.