MelanomaPhase 1NCT05739006
Clinical Trial to Evaluate the PK and Safety of BCD-201 and Keytruda® in Patients With Advanced Malignancies
A Phase 1 study testing BCD-201 and Keytruda in people with Melanoma and Non Small Cell Lung Cancer, run by Biocad at 3 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Non Small Cell Lung Cancer
- 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
- 131 participants
- Where
- 3 sitesRussia
- Study dates
- 8 Feb 2021to 31 Aug 2023
- Phase
- Phase 1
- 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;
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation
Moscow
Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"
Omsk
State Budgetary Healthcare Institution "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"
Saint Petersburg, 197758
About this study
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
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
- Melanoma, Non Small Cell Lung Cancer
- Being tested
- BCD-201, Keytruda
- Medical subject headings
- Melanoma, Carcinoma, Non-Small-Cell Lung
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 |
|---|---|---|
| Group 1 | Experimental | BCD-201 200 mg by intravenous infusions once every 3 weeks Receives: Drug: BCD-201 |
| Group 2 | Active comparator | Keytruda 200 mg by intravenous infusions once every 3 weeks Receives: Drug: Keytruda |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-504) of pembrolizumab
area under the drug concentration-time curve in the time interval from 0 to 504 hours
Measured: pre-dose to week 25, 77 timepoints
Secondary outcomes (11)
AUC(0-∞) of pembrolizumab
Area under the drug concentration-time curve in the time interval from 0 to ∞
Measured: pre-dose to week 25, 77 timepoints
Cmax
maximum concentration of pembrolizumab
Measured: pre-dose to week 25, 77 timepoints
Tmax
time to maximum concentration of pembrolizumab
Measured: pre-dose to week 25, 77 timepoints
T½
Half-life period
Measured: pre-dose to week 25, 77 timepoints
Vd
Steady-state volume of distribution of the drug substance
Measured: pre-dose to week 25, 77 timepoints
Cmin
minimum concentration of pembrolizumab
Measured: pre-dose to week 25, 77 timepoints
kel
Elimination rate constant
Measured: pre-dose to week 25, 77 timepoints
Cl
Total clearance
Measured: pre-dose to week 25, 77 timepoints
Safety assessment
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
Measured: Day 1 to Day 169
Immunogenicity assessment
the frequency of binding and neutralizing anti-pembrolizumab antibody production
Measured: pre-dose to week 25, 5 timepoints
To compare the results of pilot assessment of BCD-201 and Keytruda efficacy
overall response rate (ORR)
Measured: Day 1 to week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start8 Feb 2021
- Primary completion21 Jun 2022
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739006
- Sponsor's protocol ID
- BCD-201-1
- Status last verified
- Aug 2023
- First submitted
- 13 Feb 2023
- Last updated
- 2 Aug 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05739006
- Acronym / sponsor ID
- BCD-201-1
- Conditions
- Melanoma, Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 131 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 22 Feb 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.
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.
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 |
|---|---|---|
| Group 1 | Experimental | Drug: BCD-201BCD-201 200 mg by intravenous infusions once every 3 weeks |
| Group 2 | Active comparator | Drug: KeytrudaKeytruda 200 mg by intravenous infusions 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 (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
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 | Group 1 |
| KeytrudaAlso: pembrolizumabup to 8 treatment cycles | Drug | Group 2 |
Primary outcome
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
11 secondary outcomes
AUC(0-∞) of pembrolizumab
Time frame: pre-dose to week 25, 77 timepoints
Cmax
Time frame: pre-dose to week 25, 77 timepoints
Tmax
Time frame: pre-dose to week 25, 77 timepoints
T½
Time frame: pre-dose to week 25, 77 timepoints
Vd
Time frame: pre-dose to week 25, 77 timepoints
Cmin
Time frame: pre-dose to week 25, 77 timepoints
kel
Time frame: pre-dose to week 25, 77 timepoints
Cl
Time frame: pre-dose to week 25, 77 timepoints
Safety assessment
Time frame: Day 1 to Day 169
Immunogenicity assessment
Time frame: pre-dose to week 25, 5 timepoints
To compare the results of pilot assessment of BCD-201 and Keytruda efficacy
Time frame: Day 1 to week 25
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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 1 study testing BCD-201 and Keytruda in people with Melanoma and Non Small Cell Lung Cancer, 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 6 inclusion and 11 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 2 Aug 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
AUC(0-504) of pembrolizumab (time frame: pre-dose to week 25, 77 timepoints). 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 2 Aug 2023.