Trials / Unknown
UnknownNCT05986331
Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma
A Randomized, Double-Blind Clinical Study of the Efficacy and Safety of BCD-201 (JSC BIOCAD) and Keytruda® in Patients With Unresectable or Metastatic Melanoma
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 366 (actual)
- Sponsor
- Biocad · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This clinical study is designed as a randomized, double-blind trial. Subjects with unresectable, metastatic, or recurrent skin melanoma will be randomized to one of the two study groups (BCD-201 group and Keytruda group) at a 1:1 ratio. The goal of this study is to compare the efficacy and safety of BCD-201 and Keytruda as first-line therapy in subjects with unresectable, metastatic, or recurrent skin melanoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BCD-201 | up to 8 treatment cycles |
| DRUG | Keytruda | up to 8 treatment cycles |
Timeline
- Start date
- 2022-07-18
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
- First posted
- 2023-08-14
- Last updated
- 2023-09-21
Locations
3 sites across 1 country: Russia
Source: ClinicalTrials.gov record NCT05986331. Inclusion in this directory is not an endorsement.