Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy

NCT ID: NCT04928365

Last Updated: 2021-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-25

Study Completion Date

2023-03-25

Brief Summary

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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

Detailed Description

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Conditions

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Melanoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Advanced melanoma patients

Group Type OTHER

Anti-PD-1 monoclonal antibody

Intervention Type DRUG

Anti-PD-1 therapy

Stage III and IV melanoma patients after radical surgery

Group Type OTHER

Anti-PD-1 monoclonal antibody

Intervention Type DRUG

Anti-PD-1 therapy

Interventions

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Anti-PD-1 monoclonal antibody

Anti-PD-1 therapy

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blokhin's Russian Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

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Irina Mikhaylova

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Irina N Mikhaylova, DSc

Role: CONTACT

8 499 324 90 24

Facility Contacts

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Irina N Mikhaylova, DSc

Role: primary

8 499 324 90 24

Other Identifiers

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Cytokim-01

Identifier Type: -

Identifier Source: org_study_id

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