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MelanomaPhase 2MIRACULUMNCT03269565

International Trial of the Efficacy and Safety of BCD-100 in Patients With Melanoma

A Phase 2 study testing BCD-100 in people with Melanoma, run by Biocad at 9 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as 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-100
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
9 sitesRussia
Study dates
31 Aug 2017to Jan 2021
Phase
Phase 2
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 Form and the subject's ability to follow the Protocol requirements;
  • Age: 18 years and older at the signing of the informed consent;
  • Histologically verified (documented) unresectable/metastatic melanoma;
  • Newly diagnosed advanced/metastatic melanoma or progressive disease during (or after) systemic chemotherapy ;
  • Available tissue blocks for histological examination or patient's agreement to give biopsy specimens for PD-L1 expression status ;
  • ECOG performance status of 0 or 1;
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  • LDH less than or equal to 2×upper limit of normal;
  • At least one RESICT 1.1-defined measurable target lesion confirmed by an independent review;
  • All prior treatment-related toxicities/surgery-related adverse events must be less than or equal to Grade 2 according to CTCAE 4.03, except for chronic/permanent damage caused by an AE that does not affect the safety profile of the investigational therapy (e.g., alopecia);
  • Adequate organ system function ;
  • Life expectancy of at least 12 weeks from the screening.
  • Patients with reproductive potential must agree to practice acceptable methods of birth control throughout the entire trial period, starting from signing the informed consent and up to 12 weeks after the last dose of BCD-100.

Who cannot join

  • Evidence of severe or concomitant diseases/life-threatening complications of the main condition (e.g., massive pleural, pericardial, or peritoneal effusion that requires medical intervention , pulmonary lymphangitis) at the signing of the informed consent;
  • Subjects with progressive/symptomatic brain metastases (e.g., brain edema, spinal cord compression) or brain metastases that need therapy with corticosteroids and/or anticonvulsants ;
  • Any concomitant disease observed at the screening that increases the risk of adverse events during the investigational therapy:
  • Grade III-IV stable angina, unstable angina, or a history of myocardial infarction within 6 months prior to signing the informed consent;
  • Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system;
  • Severe, resistant hypertension;
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  • History of atopic asthma, angioedema;
  • Moderate to severe respiratory failure, Grade 3 to 4 chronic obstructive pulmonary disease;
  • Any other concomitant condition (e.g., metabolism, blood, hepatic, renal, pulmonary, neurological, endocrine, cardiac, infectious, or gastrointestinal disorder) that constitutes an unacceptable risk to the patient's health during the investigational therapy;
  • Systemic autoimmune diseases (including but not limited to SLE, Crohn's disease, ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.) ;
  • Endocrine disorders that cannot be adequately controlled by hormone replacement therapy without any dose modification within 28 days prior to the start of the investigational therapy;
  • Patients who need therapy with corticosteroids or other immunosuppressants;
  • Blood disorders :
  • Neutrophils <1.5×109/L;
  • Platelets <100×109/L;
  • Hb <90 g/L;
  • Impaired renal function: creatinine ≥1.5×ULN;
  • Impaired liver function :
  • Bilirubin ≥1.5×ULN (≤50 μmol/L for patients with Gilbert's syndrome);
  • AST/ALT ≥2.5×ULN (5×ULN for patients with liver metastases);
  • ALP ≥5×ULN;
  • LDH >2×ULN;
  • Anti-cancer therapy (surgery, chemotherapy) within 28 days prior to the first dose of the investigational product; radiotherapy within 14 days prior to the first dose of the investigational product;
  • Prior treatment with anti-CTLA4 and/or anti-PD-1/PD-L1/PD-L2 agents;
  • Prior targeted therapy ;
  • Patients who have received more than two lines of systemic chemotherapy for unresectable or metastatic melanoma;
  • Concomitant cancer (except for cervical carcinoma in situ after radical surgery or basal cell/squamous cell carcinoma after radical surgery);
  • Any condition that prevents a patient from following the Protocol procedures (dementia, neurological or mental disorders, drug/alcohol abuse, etc.) ;
  • Simultaneous participation in other clinical trials , participation in other clinical trials within 30 days prior to the first dose of the investigational product;
  • Acute infection or the acute phase of chronic infection within 28 days prior the first dose of the investigational product;
  • Active HBV/HCV/HIV infection, active syphilis ;
  • Patients unable to receive an IV infusion of BCD-100;
  • Patients unable to receive an IV contrast agent;
  • Hypersensitivity to any of the components of BCD-100;
  • History of hypersensitivity to any therapeutic monoclonal antibody;
  • Pregnant or lactating female.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Russia9 sites

  • State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Regional Clinical Oncology Dispensary" (SBHI AR ARCOD)

    Arkhangelsk

  • "N.N. Blokhin Russian Cancer Research Center"

    Moscow

  • State Budgetary Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD)

    Moscow

  • "Pavlov First Saint Petersburg State Medical University"

    Saint Petersburg

  • "Saint Petersburg Clinical Research and Practice Center for Specialized Medical Care (Oncology)"

    Saint Petersburg

  • Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation (FSBI N.N. Petrov RIO (Chemotherapy Department with Innovative Technologies)

    Saint Petersburg

  • Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation, Research Department of the Innovative Methods of Therapeutic Oncology and Rehabilitation (FSBI N.N. Petrov RIO of the

    Saint Petersburg

  • LLC BioEk

    Saint Petersburg

  • State Budgetary Institution of Healthcare "Clinical Oncology Dispensary of Chelyabinsk Region" (SBIH CODCR)

    Saint Petersburg

Other trials in Russia

About this study

Official title: An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients With Unresectable/Metastatic Melanoma.

An International Multicenter Open-label Randomized Trial of the Efficacy, Pharmacokinetics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) as Monotherapy in Patients with Unresectable/Metastatic Melanoma.

Read the detailed description

This trial has been designed as an international multicenter open-label Phase II trial.

The trial aims to investigate the efficacy, pharmacokinetics, safety, and immunogenicity of two dosage regimens of BCD-100 (JSC BIOCAD, Russia) as monotherapy in patients with unresectable/metastatic melanoma.

According to the design, the trial will include two arms of patients. Each of the trial arms will receive repeated doses of the test drug as monotherapy; BCD-100 will be administered using one of the following dosage regimens established in a Phase I trial:

  • Monotherapy, BCD-100 1 mg/kg Q2W (IV infusion over 60 minutes; if a 60-minute infusion is tolerated well, all following doses can be administered over 30 minutes);
  • Monotherapy, BCD-100 3 mg/kg Q3W (IV infusion over 60 minutes; if a 60-minute infusion is tolerated well, all following doses can be administered over 30 minutes).
Conditions
Melanoma
Being tested
BCD-100
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-100Biological

    Anti-PD-1 monoclonal antibody

Study groups in NCT03269565
Study groupRoleWhat they receive
Arm 1ExperimentalBCD-100 1 mg/kg Q2W;
Receives: Biological: BCD-100
Arm 2ExperimentalBCD-100 3 mg/kg Q3W.
Receives: Biological: BCD-100

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    Overall response rate (partial response+complete response rates) assessed according to irRECIST in an mITT population during BCD-100 therapy

    Measured: 1 year

Secondary outcomes (2)

  1. One-year progression-free survival rate ;

    One-year progression-free survival rate during BCD-100 therapy;

    Measured: 1 year

  2. Percentage of patients with severe immune-related AEs

    Percentage of patients with severe immune-related AEs (CTCAE 4.03 Grade 3 or greater);

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2017
  2. Study start31 Aug 2017
  3. Primary completion29 Aug 2018
  4. Study completionJan 2021 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03269565
Sponsor's protocol ID
BCD-100-2
Acronym
MIRACULUM
Status last verified
Sep 2020
First submitted
30 Aug 2017
Last updated
18 Sep 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Demidov L, Kharkevich G, Petenko N, Moiseenko V, Protsenko S, Semiglazova T, Zimina A, Kovalenko N, Fadeeva N, Kirtbaya D, Belogortsev I, Tantsyrev D, Odintsova S, Nesterova A, Vorontsova K, Makarycheva Y, Linkova Y, Zinkina-Orikhan A, Siliutina A, Sorokina I, Liaptseva D, Chistyakov V, Lutsky A. A phase III study to access the safety and efficacy of prolgolimab 250 mg fixed dose administered every 3 weeks versus prolgolimab 1 mg/kg every 2 weeks in patients with metastatic melanoma (FLAT). Front Oncol. 2024 Sep 4;14:1385685. doi: 10.3389/fonc.2024.1385685. eCollection 2024.

    PubMed 39296979

  • Tjulandin S, Demidov L, Moiseyenko V, Protsenko S, Semiglazova T, Odintsova S, Zukov R, Lazarev S, Makarova Y, Nechaeva M, Sakaeva D, Andreev A, Tarasova A, Fadeyeva N, Shustova M, Kuryshev I. Novel PD-1 inhibitor prolgolimab: expanding non-resectable/metastatic melanoma therapy choice. Eur J Cancer. 2021 May;149:222-232. doi: 10.1016/j.ejca.2021.02.030. Epub 2021 Apr 17.

    PubMed 33872982

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BCD-100 in people with Melanoma, run by Biocad at 9 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 12 inclusion and 36 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 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Overall response rate (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03269565, which also lists 2 linked publications.

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 18 Sep 2020.

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