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MelanomaPhase 2OBERTONNCT03913923

Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma

A Phase 2 study testing BCD-217 and BCD-100 in people with Melanoma and Melanoma Metastatic, run by Biocad at 23 sites in 2 countries.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a multicenter randomized double-blind placebo-controlled phase II clinical trial. The purpose of this trial is to evaluate efficacy and safety of therapy consisting of BCD-217 (fixed dose combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies) and sequential BCD-100 (anti-PD-1 monoclonal antibody)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma, Melanoma Metastatic
What is being tested?
BCD-217 and BCD-100
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
117 participants
Where
23 sitesin 2 countries
Study dates
1 Jul 2019to Dec 2023
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) melanoma;
  • Previously untreated unresectable stage III melanoma or metastatic stage IV melanoma;
  • Available tissue blocks for histological examination or patient's agreement to give biopsy specimens
  • Patient's consent for PD-L1 expression status and BRAF V600 testing;
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  • ECOG performance status of 0 or 1;
  • Life expectancy of at least 12 weeks from the screening;
  • At least one RECIST 1.1-defined measurable target lesion confirmed by an independent review;
  • 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 24 weeks after the last dose of investigational drug.

Who cannot join

  • Indications for radical (surgical, radiation) therapy;
  • A history of previous systemic antitumor therapy for unresectable or metastatic melanoma ;
  • Prior therapy with checkpoint inhibitors (e.g., anti-CTLA-4 and/or anti-PD-1/PD-L1/PD-L2 products);
  • Prior therapy with BRAF and MEK protein kinase inhibitors;
  • Use of immunostimulants, monoclonal antibodies and/or colony-stimulating factors within less than 4 weeks prior to randomization in the study;
  • Ocular melanoma;
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  • Mucosal melanoma;
  • CNS metastases;
  • Impossibility to determine PD-L1 status and/or BRAF status;
  • Subjects with severe comorbidities, 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 form;
  • Ongoing concomitant diseases at the time of screening, which increase the risk of severe adverse events during the administration of the study therapy:
  • stable angina, functional class III-IV,
  • unstable angina or a history of myocardial infarction within less than 6 months prior to signing the informed consent form;
  • moderate to severe heart failure (classes III and IV according to NYHA classification);
  • uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg) ;
  • a history of atopic asthma , angioedema;
  • respiratory failure (moderate to severe), grade 3 or 4 chronic obstructive pulmonary disease;
  • any other concomitant diseases (including, but not limited to, metabolic, hematological, renal, hepatic, pulmonary, neurological, endocrine, cardiac, infectious, gastrointestinal disorders), which expose the patient to an unacceptable risk during the study therapy;
  • Known or suspected systemic autoimmune diseases (including, but not limited to, systemic lupus erythematosus, Crohn's disease, nonspecific ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.) ;
  • History of interstitial pulmonary disease or pneumonitis requiring systemic glucocorticoids;
  • The need for glucocorticoid therapy (at >10 mg/day prednisolone equivalent doses) or any other drugs with immunosuppressive effects within 14 days prior to randomization;
  • Hematologic abnormalities :
  • neutrophils <1.5×109/L,
  • platelets <100×109/L,
  • hemoglobin <90 g/L;
  • Renal impairment: creatinine ≥2.5×ULN;
  • Hepatic impairment :
  • total bilirubin ≥3×ULN (except for the patients with Gilbert's syndrome, in whom bilirubin levels should not exceed 50 μmol/L),
  • AP, AST or ALT ≥2.5×ULN (≥5×ULN in case of patients with liver metastases);
  • Any antitumor treatment within less than 4 weeks or surgery within less than 28 days prior to randomization within the study;
  • History of oncological disease, except for radically treated diseases with remission for over 5 years prior randomization in this study ;
  • Conditions limiting the patient's ability to comply with the Protocol requirements (in the Investigator's opinion );
  • Participation in other clinical studies within less than 30 days prior to randomization and during this clinical study ;
  • Acute infections or activation of chronic infectious diseases or systemic antibacterial therapy within less than 28 days prior to randomization;
  • Active hepatitis B, active hepatitis C (confirmed by PCR), active syphilis, HIV-infection, currently or previously ;
  • Impossibility to administer the investigational product intravenously;
  • Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media);
  • Hypersensitivity to any of the components of BCD-100 or BCD-217;
  • A history of hypersensitivity to monoclonal antibody products;
  • Pregnancy or breastfeeding.

Trial locations and contacts

23 sites in 2 countries.

23 sites in 2 countries

Russia21 sites

  • State Budgetary Healthcare Institution of the Ar-khangelsk Region "Arkhangelsk Clinical Oncology Dispensary"

    Arkhangelsk, 163045

  • Territorial State Budgetary Healthcare Institution "Altai Territorial Clinical Oncology Dispensary"

    Barnaul, 656045

  • State Budgetary Healthcare Institution "Chelyabinsk Regional Clinical Center for Oncology and Nuclear Medicine",

    Chelyabinsk, 454087

  • State public health institution "Republican Clinical Oncology Dispensary" of the Ministry of Health of the Republic of Tatarstan

    Kazan'

  • Regional State Budgetary of Healthcare Insti-tution "Kostroma Oncology Dispensary"

    Kostroma

  • Krasnoyarsk Regional Clinical Oncological Dispensary named after A.I. Kryzhanovsky

    Krasnoyarsk, Krasnoyarsk Krai, 660133

  • Medsi Group of Companies Joint-Stock Company

    Moscow, 123056

  • "Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation

    Moscow

  • State Health Care Institution "Moscow City Oncology Hospital № 62" Moscow Health Department

    Moscow

  • Murmansk Regional Clinical Hospital named after P.A. Bayandina

    Murmansk, Murmansk Oblast, 183047

  • State Budgetary Healthcare Institution of the Novosi-birsk Region "Novosibirsk Regional Clinical Oncolo-gy Dispensary"

    Novosibirsk, 630108

  • State budget healthcare institution Omsk region "Clinical Oncology Dispensary"

    Omsk

  • LLC "New Clinic"

    Pyatigorsk, Stavropol Kray, 357500

  • JSC "Modern Medical Technologies"

    Saint Petersburg, 190013

  • AV Medical Group Limited Liability Company

    Saint Petersburg, 197082

  • Federal State Institution "N.N. Petrov National Medical Research Center for Oncology"

    Saint Petersburg, 197758

  • Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

    Saint Petersburg, 197758

  • Federal State Budgetary Educational Institution of Higher Education "St. Petersburg State University"

    Saint Petersburg, 199106

  • State-financed Health Institution "Samara Region Clinical Oncology Dispansary"

    Samara, 443031

  • Clinical Oncologic Dispensary No. 2

    Sochi, Krasnodar Territory, 354057

  • Regional Clinical Oncology Hospital

    Yaroslavl, Yaroslavl Oblast, 150054

Other trials in Russia

Belarus2 sites

  • Healthcare Institution "Minsk Municipal Clinical Oncolo-gy Dispensary" (MMCOD)

    Minsk, 220013

  • State Institution "N.N. Aleksandrov Republican Research and Practical Center for Oncology and Medical Radiology"

    The Settlement of Lesnoy, Minsk District

Other trials in Belarus

About this study

Official title: International Multicenter Double-Blind Placebo-Controlled Comparative Randomized Trial of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) And BCD-100 (Anti-PD-1) Therapy Compared to BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma

This is a multicenter randomized double-blind placebo-controlled phase II clinical trial. The purpose of this trial is to evaluate efficacy and safety of therapy consisting of BCD-217 (fixed dose combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies) and sequential BCD-100 (anti-PD-1 monoclonal antibody) versus BCD-100 monotherapy as first-line treatment in patients with treatment-naïve unresectable or metastatic melanoma.

Being tested
BCD-217, BCD-100, Placebo
Medical subject headings
Melanoma

What participants receive

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

  • BCD-217Biological

    Combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies, 1mg/kg and 3 mg/mg, respectively, given Q3W as IV infusion for first 4 blinded infusions

  • BCD-100Biological

    Anti-PD-1 monoclonal antibody, 3 mg/kg, given Q3W as IV infusion for first 4 blinded infusions, after - 1 mg/kg, given Q2W as IV infusion

  • PlaceboOther

    Placebo

Study groups in NCT03913923
Study groupRoleWhat they receive
BCD-217 and BCD-100ExperimentalPatients will receive 4 blinded infusions of BCD-217 plus Placebo. Starting with the fith infusion patients will receive unblinded BCD-100 monotherapy.
Receives: Biological: BCD-217; Biological: BCD-100; Other: Placebo
BCD-100 monotherapyActive comparatorPatients will receive 4 blinded infusions of BCD-100 plus Placebo. Starting with the fith infusion patients will receive unblinded BCD-100 monotherapy.
Receives: Biological: BCD-100; Other: Placebo

What is being measured

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

  1. Median Progression-Free Survival

    Measured: 2 years

Secondary outcomes (6)

  1. Progression-Free Survival (PFS)

    The time from the date of randomization until progression of disease per RECIST 1.1 and iRECIST or death

    Measured: 2 years

  2. Overall Survival (OS)

    The time from the date of randomization until death

    Measured: 2 years

  3. Overall Response Rate

    The percentage of the participants who have a Complete Response or a Partial Response as assessed by a blind independent central reviewer per RECIST 1.1. and iRECIST

    Measured: 2 years

  4. Disease Control Rate

    The percentage of the participants who have a Complete Response, a Partial Response or a Stable DIsease as assessed by a blind independent central reviewer per RECIST 1.1. and iRECIST

    Measured: 2 years

  5. Time to Response (TTR)

    TTR will be calculated from the randomization date

    Measured: 2 years

  6. Duration of Response

    DOR will be calculated from the moment of registration of response till event (progression or death)

    Measured: 2 years

Timeline

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

  1. First posted12 Apr 2019
  2. Study start1 Jul 2019
  3. Primary completionJul 2023 (estimated)
  4. Study completionDec 2023 (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
Double blind
Who is masked
Participant, Investigator
Enrolment
117 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913923
Sponsor's protocol ID
BCD-217-1
Acronym
OBERTON
Status last verified
Feb 2023
First submitted
11 Apr 2019
Last updated
10 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BCD-217 and BCD-100 in people with Melanoma and Melanoma Metastatic, run by Biocad at 23 sites in 2 countries.

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 10 inclusion and 40 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Russia, Belarus. 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?

Median Progression-Free Survival (time frame: 2 years). 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 NCT03913923.

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 10 Feb 2023.

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OBERTON Clinical Trial NCT03913923 | AzTrials