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Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy

Phase 2
Conditions
Melanoma
Interventions
Drug: Anti-PD-1 monoclonal antibody
Registration Number
NCT04928365
Lead Sponsor
Blokhin's Russian Cancer Research Center
Brief Summary

Open prospective clinical trial to develop the computer software (Intelligent prognostic system) for predicting the efficacy of anti-PD-1 immunotherapy of melanoma patients in routine practice

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
50
Inclusion Criteria
  1. Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
  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
  1. Non-compliance with the previously listed 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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Stage III and IV melanoma patients after radical surgeryAnti-PD-1 monoclonal antibody-
Advanced melanoma patientsAnti-PD-1 monoclonal antibody-
Primary Outcome Measures
NameTimeMethod
Overall survivalup to 12 months
Progression free survivalup to 12 months
Secondary Outcome Measures
NameTimeMethod
Cytokine profileup to 12 months

IL-2, IL-6, IL-7, IL-8, IL-10, IL-12p70, IL-22, (IFN)-α2, IFN-γ, NFβ/Lymphotoxin-α(LTA), MCP-1/CCL2,IP-10/CXCL10, MIG/CXCL9, GM-CSF, PDGF-AA, PDGF-AB/BB, VEGF-A

Trial Locations

Locations (1)

N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23

🇷🇺

Moscow, Russian Federation

N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23
🇷🇺Moscow, Russian Federation
Irina N Mikhaylova, DSc
Contact
8 499 324 90 24
irmikhaylova@gmail.com

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