Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04928365
• Other study ID #: Cytokim-01
• Status: Recruiting
• Phase: Phase 2
• Start date: March 25, 2021
• Est. completion date: March 25, 2023

Study information

• Verified date: June 2021
• Source: Blokhin's Russian Cancer Research Center
• Contact: Irina N Mikhaylova, DSc
• Phone: 8 499 324 90 24
• Email: irmikhaylova[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 25, 2023
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Anti-PD-1 monoclonal antibody
Anti-PD-1 therapy

Locations

Country	Name	City	State
Russian Federation	N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		up to 12 months
Primary	Progression free survival		up to 12 months
Secondary	Cytokine profile	IL-2, IL-6, IL-7, IL-8, IL-10, IL-12p70, IL-22, (IFN)-a2, IFN-?, NFß/Lymphotoxin-a(LTA), MCP-1/CCL2,IP-10/CXCL10, MIG/CXCL9, GM-CSF, PDGF-AA, PDGF-AB/BB, VEGF-A	up to 12 months