Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy
NCT ID: NCT04928365
Last Updated: 2021-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2021-03-25
2023-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Advanced melanoma patients
Anti-PD-1 monoclonal antibody
Anti-PD-1 therapy
Stage III and IV melanoma patients after radical surgery
Anti-PD-1 monoclonal antibody
Anti-PD-1 therapy
Interventions
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Anti-PD-1 monoclonal antibody
Anti-PD-1 therapy
Eligibility Criteria
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Inclusion Criteria
2. ECOG 0-1
3. Age of patients - 18 years and older
4. No prior chemotherapy, immunotherapy, radiation or hormonal therapy
5. Adequate contraception for women of childbearing age
6. Written consent of the patient to participate in the study
Exclusion Criteria
2. Pregnancy and breastfeeding
3. Therapy with systemic corticosteroids and/or other immunosuppressants within 4 weeks before the screening or a high probability of the need for their use during the study for the treatment of intercurrent pathology
4. History of another malignancy other than the study indication under this trial within 5 years of study enrollment. Does not apply to subjects who underwent successful definitive resection of basal or squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer, or other in situ cancers.
18 Years
ALL
No
Sponsors
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Blokhin's Russian Cancer Research Center
OTHER
Responsible Party
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Irina Mikhaylova
Principal investigator
Locations
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N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Cytokim-01
Identifier Type: -
Identifier Source: org_study_id
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