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

NCT03269565 | Unknown Phase 2 DMC

• 1 other identifier: BCD-100-2
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Overall response rate

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

  1 year

Secondary Outcomes (2)

• One-year progression-free survival rate ;

  1 year

• Percentage of patients with severe immune-related AEs

  1 year

Study Arms (2)

Arm 1

EXPERIMENTAL

BCD-100 1 mg/kg Q2W;

Biological: BCD-100

Arm 2

EXPERIMENTAL

BCD-100 3 mg/kg Q3W.

Biological: BCD-100

Interventions

BCD-100 BIOLOGICAL

Anti-PD-1 monoclonal antibody

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Biocad: lead

Study Sites (9)

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

Arkhangelsk, Russia

Location

"N.N. Blokhin Russian Cancer Research Center"

Moscow, Russia

Location

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

Moscow, Russia

Location

"Pavlov First Saint Petersburg State Medical University"

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

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, Russia

Location

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, Russia

Location

LLC BioEk

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

Related Publications (2)

• 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.

  PMID: 39296979 DERIVED

• 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.

  PMID: 33872982 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yulia N Linkova, MD, PhD

  Director of Clinical Development Department, BIOCAD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 1, 2017
• Study Start: August 31, 2017
• Primary Completion: August 29, 2018
• Study Completion: January 1, 2021
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

RU (9)