FLAT: Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
Study Details
Study Description
Brief 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:
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selection criteria for subjects in the study, defining the population,
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research centers,
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procedures for evaluating effectiveness and safety,
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permitted prior and concomitant therapy of the underlying disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1
|
Drug: Prolgolimab
250 mg Q3W
|
Outcome Measures
Primary Outcome Measures
- Overall response rate [6 month]
Overall response rate (partial response+complete response rates) according to RECIST 1.1
Secondary Outcome Measures
- Overall response rate [6 month]
Overall response rate (partial response+complete response rates) according to irRECIST
- Disease control rate [6 month]
Disease control rate (stabilization + partial response + complete response rates) according to RECIST 1.1
- Disease control rate [6 month]
Disease control rate (stabilization + partial response + complete response rates) according to irRECIST
- Time to response [6 month]
The time from the frirst administered dose to the response (partial or complete) according to RECIST 1.1
- Time to response [6 month]
The time from the frirst administered dose to the response (partial or complete) according to irRECIST
- Duration of Response [6 month]
Time from the response (partial or complete) repoerted date to the progression or death.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent and the subject's ability to comply with the protocol requirements.
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Age ≥18 years at the time of informed consent.
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Histologically confirmed unresectable or metastatic melanoma (with available documented evidence of relevant examinations).
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Primarily detected advanced or metastatic melanoma, or the disease progression on or after previous systemic therapy.
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Measurable target tumor lesions (at least 1 lesion) according to RECIST 1.1 criteria, confirmed by an independent reviewer.
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ECOG score 0-1.
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Absence of severe organ and system disorders.
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Life expectancy of at least 12 weeks at screening.
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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.
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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:
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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.
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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;
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Ongoing concomitant diseases at the time of screening increasing the risk of severe adverse events during the study treatment.
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The need for glucocorticoids or any other drugs with immunosuppressive effects.
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Hematologic abnormalities.
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Renal impairment.
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Hepatic impairment.
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Increased LDH >2 ULN.
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Prior treatment with anti-CTLA4 and/or anti-PD-1/PD-L1/PDL-2 drugs.
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Prior targeted therapy.
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A history of malignancies, except for radically treated diseases in remission for over 5 years prior to starting the study.
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Conditions limiting the patient's ability to comply with the protocol requirements (dementia, neurologic or mental disorders, drug or alcohol addiction, etc).
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Simultaneous participation in other clinical studies55 or participation in other clinical studies within 30 days prior to starting the study treatmen.
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Acute infections or activation of chronic infectious diseases within 28 days prior to the beginning of the study treatment.
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Active hepatitis B, active hepatitis C, HIV-infection, syphilis.
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Impossibility to administer the study drug intravenously.
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Impossibility to perform imaging examinations requiring administration of intravenous contrast media.
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Hypersensitivity to any of the components of BCD-100.
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A history of hypersensitivity to monoclonal antibody products.
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Pregnancy or breastfeeding.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Regional Clinical Oncology Dispensary" (SBHI AR ARCOD) | Arkhangel'sk | Russian Federation | ||
| 2 | State Budgetary Institution of Healthcare "Clinical Oncology Dispensary of Chelyabinsk Region" (SBIH CODCR) | Cheliabinsk | Russian Federation | ||
| 3 | N.N. Blokhin Russian Cancer Research Center | Moscow | Russian Federation | ||
| 4 | State Budgetary Healthcare Institution "Moscow Clinical Scientific Center funded by Moscow Health Department" (SBHI MCSC MHD) | Moscow | Russian Federation | ||
| 5 | 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 | Saint-Petersburg | Russian Federation | ||
| 6 | Federal State Budgetary Institution "N.N. Petrov Research Institute of Oncology" of the Ministry of Healthcare of the Russian Federation | Saint-Petersburg | Russian Federation |
Sponsors and Collaborators
- Biocad
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- BCD-100-8