MelanomaPhase 1NCT03472027
Phase I Study of BCD-145 (Anti-CTLA-4) in Patients With Unresectable/Metastatic Melanoma
A Phase 1 study testing BCD-145 in people with Melanoma, run by Biocad at 4 sites in Russia.
Trial summary
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) Monotherapy in Patients with Unresectable/Metastatic Melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- BCD-145
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesRussia
- Study dates
- 2 Oct 2017to 4 Dec 2018
- 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
- Patient provides a written informed consent and is able to follow the requirements of the Protocol;
- Age ≥ 18 years
- Histologically confirmed (well-documented test results; preferably, block specimens available) unresectable (stage III/IV) or metastatic (stage IV) melanoma (the drug will be used as the first of subsequent therapy lines);
- ECOG score of 0 to 2;
- Measurable disease (at least one lesion) according to RECIST v1.1 ;
- Resolved toxicity events from the previous therapy or adverse consequences of surgical interventions to ≤ grade 1 CTCAE v. 4.03, except for chronic/irreversible adverse events not affecting the safety of the study therapy (e.g. alopecia);
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- No severe pathology of organs or systems;
- Life expectancy of at least 16 weeks from the screening;
- Patients of childbearing potential enrolled in the study must agree to use reliable contraception methods throughout the study period, beginning 2 weeks before the inclusion in the study and up to 8 weeks after the last dose of BCD-145.
Who cannot join
- Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of >50% renal parenchyma);
- Brain metastases ;
- Severe cardiovascular disorders within 6 months before screening;
- Autoimmune diseases;
- Conditions requiring steroids or any other immunosuppressants;
- Blood disorders: ANC ≤1,500/mm3; platelets ≤100,000/mm3; or Hb ≤90 g/L;
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- Renal function impairment: creatinine ≥1.5 × ULN;
- Hepatic function impairment: bilirubin ≥1.5 × ULN; AST and ALT ≥2.5 × ULN (5 × ULN for patients with liver metastases), AlkPh ≥ 5 × ULN;
- Endocrine disorders: abnormal thyroid hormones
- Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);
- Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);
- Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;
- Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;
- Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);
- Simultaneous participation in any other clinical trial; participation in other clinical trials within 30 days before inclusion in the present study; previous participation in the present study.
- Acute infections or active chronic infections;
- Documented hepatitis B, active hepatitis C, HIV or syphilis infection;
- Intravenous administration of the drug is impossible;
- Intravenous administration of contrast agents is impossible;
- Hypersensitivity to any component of BCD-145.
- Known history of hypersensitivity to monoclonal antibodies;
- Pregnancy or breastfeeding;
Trial locations and contacts
4 sites in 1 country.
Russia4 sites
N.N. Blokhin National Medical Research Center of Oncology
Moscow, 115478
JSC "Modern Medical Technologies"
Saint Petersburg, 190013
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 197758
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Saint Petersburg, 197758
About this study
Official title: A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) in Patients With Unresectable/Metastatic Melanoma
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) Monotherapy in Patients with Unresectable/Metastatic Melanoma.
- Conditions
- Melanoma
- Being tested
- BCD-145
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCD-145Biological
Anti-CTLA-4 monoclonal antibody, IV infusion
| Study group | Role | What they receive |
|---|---|---|
| BCD-145 Monotherapy Dose Level 1 | Experimental | Not described Receives: Biological: BCD-145 |
| BCD-145 Monotherapy Dose Level 2 | Experimental | Not described Receives: Biological: BCD-145 |
| BCD-145 Monotherapy Dose Level 3 | Experimental | Not described Receives: Biological: BCD-145 |
| BCD-145 Monotherapy Dose Level 4 | Experimental | Not described Receives: Biological: BCD-145 |
| BCD-145 Monotherapy Dose Level 5 | Experimental | Not described Receives: Biological: BCD-145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose-Limiting Toxicities (DLTs)
The Investigators defined Dose-Limiting Toxicities (DLTs) as
- any treatment-related adverse events of grade 3 or greater,
- grade 3 or greater immune-mediated toxic effects (defined as an inflammatory process that compromised the function of any organ and was not attributable to another cause) that had the potential to be life threatening with continuation of therapy,
- immune-mediated toxic effects that did not resolve or improved to grade 2 or less within 14 days of onset
Measured: 85 days
Secondary outcomes (2)
Anti-Drug Antibody levels of BCD-145
Binding and neutralizing anti-drug antibody levels of BCD-145
Measured: 85 days
Number of Participants With Objective Response
Number of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as ≥30% decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study ≥4 weeks after initial documentation of response.
Pilot efficacy assessment is not the primary objective of this study and will be conducted by surrogate endpoints describing the direct antitumor effect of the drug.
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start2 Oct 2017
- Primary completion11 Sep 2018
- Study completion4 Dec 2018
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 dose escalation
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman A Ivanov, PhD, Study director, Vice President R&D, JSC BIOCAD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03472027
- Sponsor's protocol ID
- BCD-145-1
- Status last verified
- May 2019
- First submitted
- 9 Mar 2018
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) in Patients With Unresectable/Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT03472027
- Acronym / sponsor ID
- BCD-145-1
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 21 Mar 2018 (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.
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) Monotherapy in Patients with Unresectable/Metastatic Melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- 3+3 dose escalation
| Arm | Type | Receives |
|---|---|---|
| BCD-145 Monotherapy Dose Level 1 | Experimental | Biological: BCD-145 |
| BCD-145 Monotherapy Dose Level 2 | Experimental | Biological: BCD-145 |
| BCD-145 Monotherapy Dose Level 3 | Experimental | Biological: BCD-145 |
| BCD-145 Monotherapy Dose Level 4 | Experimental | Biological: BCD-145 |
| BCD-145 Monotherapy Dose Level 5 | Experimental | Biological: BCD-145 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient provides a written informed consent and is able to follow the requirements of the Protocol;
- Age ≥ 18 years
- Histologically confirmed (well-documented test results; preferably, block specimens available) unresectable (stage III/IV) or metastatic (stage IV) melanoma (the drug will be used as the first of subsequent therapy lines);
- ECOG score of 0 to 2;
- Measurable disease (at least one lesion) according to RECIST v1.1 ;
Key exclusion criteria (22 listed)
- Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of >50% renal parenchyma);
- Brain metastases ;
- Severe cardiovascular disorders within 6 months before screening;
- Autoimmune diseases;
- Conditions requiring steroids or any other immunosuppressants;
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-145Anti-CTLA-4 monoclonal antibody, IV infusion | Biological | BCD-145 Monotherapy Dose Level 1, BCD-145 Monotherapy Dose Level 2, BCD-145 Monotherapy Dose Level 3, BCD-145 Monotherapy Dose Level 4, BCD-145 Monotherapy Dose Level 5 |
Primary outcome
Number of participants with Dose-Limiting Toxicities (DLTs)
Time frame: 85 days
The Investigators defined Dose-Limiting Toxicities (DLTs) as * any treatment-related adverse events of grade 3 or greater, * grade 3 or greater immune-mediated toxic effects (defined as an inflammatory process that compromised the function of any organ and was not attributable to another cause) that had the potential to be life threatening with continuation of therapy, * immune-mediated toxic effects that did not resolve or improved to grade 2 or less within 14 days of onset
2 secondary outcomes
Anti-Drug Antibody levels of BCD-145
Time frame: 85 days
Number of Participants With Objective Response
Time frame: 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2019.
- 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.
Roman A Ivanov, PhD study director
Vice President R&D, JSC BIOCAD
4 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-145 in people with Melanoma, run by Biocad at 4 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 9 inclusion and 22 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: finished, as of the sponsor's last update on 9 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with Dose-Limiting Toxicities (DLTs) (time frame: 85 days). 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 9 May 2019.