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
- Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
- ECOG 0-1
- Age of patients - 18 years and older
- No prior chemotherapy, immunotherapy, radiation or hormonal therapy
- Adequate contraception for women of childbearing age
- Written consent of the patient to participate in the study
Exclusion Criteria
- Non-compliance with the previously listed criteria
- Pregnancy and breastfeeding
- 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
- 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
Group Intervention Description Stage III and IV melanoma patients after radical surgery Anti-PD-1 monoclonal antibody - Advanced melanoma patients Anti-PD-1 monoclonal antibody -
- Primary Outcome Measures
Name Time Method Overall survival up to 12 months Progression free survival up to 12 months
- Secondary Outcome Measures
Name Time Method Cytokine profile up 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 FederationIrina N Mikhaylova, DScContact8 499 324 90 24irmikhaylova@gmail.com