prolgolimab 250 mg q3w in patients with unresectable or metastatic melanoma

Conditions: Unresectable or Metastatic Melanoma

Summary: multicentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with unresectable or metastatic melanoma, as well as collecting pharmacokinetics and safety data. the study is conducted under the same conditions as the previously conducted study bcd-100-2/miraculum. this means that this study no. bcd-100-8/flat has identical parameters such as: * selection criteria for subjects in the study, defining the population, * research centers, * procedures for evaluating effectiveness and safety, * permitted prior and concomitant therapy of the underlying disease.


Eligibility criteria:
inclusion criteria: * signed informed consent and the subject's ability to comply with the protocol requirements. * age ≥18 years at the time of informed consent. * histologically confirmed unresectable or metastatic melanoma (with available documented evidence of relevant examinations). * primarily detected advanced or metastatic melanoma, or the disease progression on or after previous systemic therapy. * measurable target tumor lesions (at least 1 lesion) according to recist 1.1 criteria, confirmed by an independent reviewer. * ecog score 0-1. * absence of severe organ and system disorders. * life expectancy of at least 12 weeks at screening. * for patients of childbearing potential: willingness to use reliable methods of contraception throughout the study, from the time of informed consent and for up to 6 weeks after the last dose of the study drug. * available blocks for a histological examination and/or the patient's consent for collection of biopsy43 samples to obtain histological material to assess the pd-l1 status. exclusion criteria: * patients with severe concomitant disorders, life-threatening acute complications of the primary disease (including massive pleural, pericardial, or peritoneal effusions requiring intervention, pulmonary lymphangitis) at the time of informed consent. * cns metastases that are progressing or associated with clinical symptoms (e.g., cerebral edema, spinal compression) or requiring the use of glucocorticosteroids and/or anticonvulsants; * ongoing concomitant diseases at the time of screening increasing the risk of severe adverse events during the study treatment. * the need for glucocorticoids or any other drugs with immunosuppressive effects. * hematologic abnormalities. * renal impairment. * hepatic impairment. * increased ldh \>2 uln. * prior treatment with anti-ctla4 and/or anti-pd-1/pd-l1/pdl-2 drugs. * prior targeted therapy. * a history of malignancies, except for radically treated diseases in remission for over 5 years prior to starting the study. * conditions limiting the patient's ability to comply with the protocol requirements (dementia, neurologic or mental disorders, drug or alcohol addiction, etc). * simultaneous participation in other clinical studies55 or participation in other clinical studies within 30 days prior to starting the study treatmen. * acute infections or activation of chronic infectious diseases within 28 days prior to the beginning of the study treatment. * active hepatitis b, active hepatitis c, hiv-infection, syphilis. * impossibility to administer the study drug intravenously. * impossibility to perform imaging examinations requiring administration of intravenous contrast media. * hypersensitivity to any of the components of bcd-100. * a history of hypersensitivity to monoclonal antibody products. * pregnancy or breastfeeding.