Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy

June 13, 2021 updated by: Irina Mikhaylova, Blokhin's Russian Cancer Research Center

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 115478
        • Recruiting
        • N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Advanced melanoma patients
Drug: Anti-PD-1 monoclonal antibody
Anti-PD-1 therapy
Other: Stage III and IV melanoma patients after radical surgery
Drug: Anti-PD-1 monoclonal antibody
Anti-PD-1 therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival
Time Frame: up to 12 months
up to 12 months
Overall survival
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytokine profile
Time Frame: 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
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Blokhin's Russian Cancer Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Actual)

May 11, 2021

Study Completion (Anticipated)

March 25, 2023

Study Registration Dates

First Submitted

June 7, 2021

First Submitted That Met QC Criteria

June 13, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 13, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cytokim-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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