Back to resultsEvaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy
Primary Purpose
Melanoma
Status
Unknown status
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
Anti-PD-1 monoclonal antibody
Sponsored by
About this trial
This is an interventional diagnostic trial for Melanoma
Eligibility Criteria
Inclusion Criteria:
- Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
- ECOG 0-1
- Age of patients - 18 years and older
- No prior chemotherapy, immunotherapy, radiation or hormonal therapy
- Adequate contraception for women of childbearing age
- Written consent of the patient to participate in the study
Exclusion Criteria:
- Non-compliance with the previously listed criteria
- Pregnancy and breastfeeding
- 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
- 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.
Sites / Locations
- N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Advanced melanoma patients
Stage III and IV melanoma patients after radical surgery
Arm Description
Outcomes
Primary Outcome Measures
Overall survival
Progression free survival
Secondary Outcome Measures
Cytokine profile
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
Full Information
NCT ID
NCT04928365
First Posted
June 7, 2021
Last Updated
June 13, 2021
Sponsor
Blokhin's Russian Cancer Research Center
1. Study Identification
Unique Protocol Identification Number
NCT04928365
Brief Title
Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 25, 2021 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
March 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Blokhin's Russian Cancer Research Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Advanced melanoma patients
Arm Type
Other
Arm Title
Stage III and IV melanoma patients after radical surgery
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Anti-PD-1 monoclonal antibody
Intervention Description
Anti-PD-1 therapy
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
up to 12 months
Title
Progression free survival
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Cytokine profile
Description
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
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Morphological verification of cutaneous melanoma. Verification of metastases is not necessary
ECOG 0-1
Age of patients - 18 years and older
No prior chemotherapy, immunotherapy, radiation or hormonal therapy
Adequate contraception for women of childbearing age
Written consent of the patient to participate in the study
Exclusion Criteria:
Non-compliance with the previously listed criteria
Pregnancy and breastfeeding
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
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irina N Mikhaylova, DSc
Phone
8 499 324 90 24
Email
irmikhaylova@gmail.com
Facility Information:
Facility Name
N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irina N Mikhaylova, DSc
Phone
8 499 324 90 24
Email
irmikhaylova@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy
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