Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy

Blokhin's Russian Cancer Research Center

Status and phase: Unknown; Phase 2

Conditions: Melanoma

Treatments: Drug: Anti-PD-1 monoclonal antibody

Study type: Interventional

Funder types: Other

Identifiers

NCT04928365

Cytokim-01

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Advanced melanoma patients

Other group

Treatment:

Drug: Anti-PD-1 monoclonal antibody

Stage III and IV melanoma patients after radical surgery

Other group

Treatment:

Drug: Anti-PD-1 monoclonal antibody