Melanoma (Skin)Phase 3NCT05986331
Clinical Study of the Efficacy and Safety of BCD-201 and Keytruda in Subjects With Advanced Melanoma
A Phase 3 study testing BCD-201 and Keytruda in people with Melanoma (Skin), run by Biocad at 3 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- BCD-201 and Keytruda
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 3 sitesRussia
- Study dates
- 18 Jul 2022to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent;
- Histologically confirmed melanoma;
- Tumor first detected at the stage of advanced unresectable or metastatic disease, or disease progressing during or recurring after previous radical therapy;
- ECOG score 0-1;
- At least one measurable lesion according to RECIST 1.1;
- Laboratory test results consistent with adequate functioning of systems and organs;
- Willingness of men and women of childbearing potential to use highly effective contraceptive methods from the signing of the informed consent form, throughout the study and for 6 months after the administration of the last product dose.
Who cannot join
- Indications for radical therapy (surgery, radiation therapy);
- Uveal, ocular or mucosal melanoma;
- Active CNS metastases and/or carcinomatous meningitis;
- Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease;
- 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);
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- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
Omsk
"Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"
Saint Petersburg
Federal State Budgetary Educational Institution of Higher Education "Saint Petersburg State University"
Saint Petersburg
About this study
Official title: 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
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
- Melanoma (Skin)
- Being tested
- BCD-201, Keytruda
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-201Drug
Also called Pembrolizumab
up to 8 treatment cycles
KeytrudaDrug
Also called pembrolizumab
up to 8 treatment cycles
| Study group | Role | What they receive |
|---|---|---|
| BCD-201 group | Experimental | BCD-201 200 mg as a 30-minute intravenous infusion once every 3 weeks Receives: Drug: BCD-201 |
| Keytruda | Active comparator | Keytruda 200 mg as a 30-minute intravenous infusion once every 3 weeks Receives: Drug: Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group
ORR according to RECIST 1.1
Measured: 24 weeks of treatment
Secondary outcomes (17)
To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group
ORR according to iRECIST
Measured: every 12 weeks up to 2 years
To compare the duration of response in the BCD-201 group and the Keytruda group
Duration of response will be calculated from the moment of registration of response till event (progression or death)
Measured: up to 2 years
To compare the time to response according to RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
time to response will be calculated from the randomization date
Measured: every 12 weeks up to 2 years
To compare the disease control rate in the BCD-201 group and the Keytruda group
The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease
Measured: up to 2 years
To compare the progression-free survival (PFS) per RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
The time from the date of randomization until progression of disease according to RECIST 1.1 / iRECIST criteria or death
Measured: up to 2 years
To compare the overall survival in the BCD-201 group and the Keytruda group
The time from the date of randomization until death
Measured: up to 2 years
To compare the incidence of Treatment-Emergent Adverse Events (Safety profiles of BCD-201 and Keytruda)
Presence of any adverse events (AEs), presence of adverse reactions (ARs), presence of serious adverse reactions (SARs), presence of severe ARs (grade 3 or higher severity according to CTCAE v.5.0), presence of ARs leading to discontinuation of study therapy, presence of immune-mediated AEs
Measured: through study completion, an average of 2 years.
Area under the concentration-time curve (AUC(0-504))
Area under the plasma concentration versus time curve in the time interval from 0 to 504 hours
Measured: up to 24 weeks of the double-blind treatment period
AUC(0-∞)
Area under the plasma concentration versus time curve in the time interval from 0 to time infinity
Measured: up to 24 weeks of the double-blind treatment period
Peak Plasma Concentration (Cmax)
maximum concentration of pembrolizumab
Measured: up to 24 weeks of the double-blind treatment period
Time to maximum concentration (Tmax)
time to maximum concentration of pembrolizumab
Measured: up to 24 weeks of the double-blind treatment period
Elimination rate constant (kel)
kel of pembrolizumab
Measured: up to 24 weeks of the double-blind treatment period
Total clearance (Cl)
Cl of pembrolizumab
Measured: up to 24 weeks of the double-blind treatment period
Steady-state volume of distribution of the drug substance (Vd)
Vd of pembrolizumab
Measured: up to 24 weeks of the double-blind treatment period
Half-life period (T1/2)
T1/2 of pembrolizumab
Measured: up to 24 weeks of the double-blind treatment period
Concentrations at the end of each infusion (CEOI)
concentrations at the end of each infusion of pembrolizumab
Measured: up to 24 weeks of the double-blind treatment period
To compare the immunogenicity of BCD-201 and Keytruda.
Development of binding and neutralizing antibodies to pembrolizumab
Measured: pre-dose to day169 of the double-blind treatment period, 8 timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start18 Jul 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by BiocadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05986331
- Sponsor's protocol ID
- BCD-201-2
- Status last verified
- Sep 2023
- First submitted
- 13 Feb 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05986331
- Acronym / sponsor ID
- BCD-201-2
- Conditions
- Melanoma (Skin)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCD-201 group | Experimental | Drug: BCD-201BCD-201 200 mg as a 30-minute intravenous infusion once every 3 weeks |
| Keytruda | Active comparator | Drug: KeytrudaKeytruda 200 mg as a 30-minute intravenous infusion once every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent;
- Histologically confirmed melanoma;
- Tumor first detected at the stage of advanced unresectable or metastatic disease, or disease progressing during or recurring after previous radical therapy;
- ECOG score 0-1;
- At least one measurable lesion according to RECIST 1.1;
Key exclusion criteria (10 listed)
- Indications for radical therapy (surgery, radiation therapy);
- Uveal, ocular or mucosal melanoma;
- Active CNS metastases and/or carcinomatous meningitis;
- Subjects with severe concomitant disorders, life-threatening acute complications of the primary disease;
- Concomitant diseases and/or conditions that significantly increase the risk of AEs during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCD-201Also: Pembrolizumabup to 8 treatment cycles | Drug | BCD-201 group |
| KeytrudaAlso: pembrolizumabup to 8 treatment cycles | Drug | Keytruda |
Primary outcome
To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group
Time frame: 24 weeks of treatment
ORR according to RECIST 1.1
17 secondary outcomes
To compare the ORR according to iRECIST in the BCD-201 group and the Keytruda group
Time frame: every 12 weeks up to 2 years
To compare the duration of response in the BCD-201 group and the Keytruda group
Time frame: up to 2 years
To compare the time to response according to RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
Time frame: every 12 weeks up to 2 years
To compare the disease control rate in the BCD-201 group and the Keytruda group
Time frame: up to 2 years
To compare the progression-free survival (PFS) per RECIST 1.1 and iRECIST in the BCD-201 group and the Keytruda group
Time frame: up to 2 years
To compare the overall survival in the BCD-201 group and the Keytruda group
Time frame: up to 2 years
To compare the incidence of Treatment-Emergent Adverse Events (Safety profiles of BCD-201 and Keytruda)
Time frame: through study completion, an average of 2 years.
Area under the concentration-time curve (AUC(0-504))
Time frame: up to 24 weeks of the double-blind treatment period
AUC(0-∞)
Time frame: up to 24 weeks of the double-blind treatment period
Peak Plasma Concentration (Cmax)
Time frame: up to 24 weeks of the double-blind treatment period
Time to maximum concentration (Tmax)
Time frame: up to 24 weeks of the double-blind treatment period
Elimination rate constant (kel)
Time frame: up to 24 weeks of the double-blind treatment period
Total clearance (Cl)
Time frame: up to 24 weeks of the double-blind treatment period
Steady-state volume of distribution of the drug substance (Vd)
Time frame: up to 24 weeks of the double-blind treatment period
Half-life period (T1/2)
Time frame: up to 24 weeks of the double-blind treatment period
Concentrations at the end of each infusion (CEOI)
Time frame: up to 24 weeks of the double-blind treatment period
To compare the immunogenicity of BCD-201 and Keytruda.
Time frame: pre-dose to day169 of the double-blind treatment period, 8 timepoints
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCD-201 and Keytruda in people with Melanoma (Skin), run by Biocad at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the overall response rate (ORR) in the BCD-201 group and the Keytruda group (time frame: 24 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.