Melanoma
Conditions
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
Interventions
DRUGAnti-PD-1 monoclonal antibody
Anti-PD-1 therapy
Sponsors
Blokhin's Russian Cancer Research Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | up to 12 months |
| Progression free survival | up to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Russia
Contacts
Primary ContactIrina N Mikhaylova, DSc
Outcome results
None listed