Overview

Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy

Status:
Recruiting

Trial end date:
2023-03-25

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Blokhin's Russian Cancer Research Center

Treatments:

Antibodies
Antibodies, Monoclonal

Criteria

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.