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

Study Timeline

• Study Start: 2021-03-25
• Primary Completion: 2021-05-11
• Status Verified: 2021-06
• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-13
• Last Update Submitted: 2021-06-13
• Study First Posted: 2021-06-16
• Last Update Posted: 2021-06-16
• Study Completion: 2023-03-25

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

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