Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocad

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.