Evaluation of Cytokine Biomarkers in Melanoma Patients Du... | NCT04928365

Studies
Evaluation of Cytokine Biomarkers in Melanoma Patients During Immunotherapy

NCT04928365

Sponsor

Blokhin's Russian Cancer Research Center

Status

Unknown status

Last Update Posted

Jun 16, 2021Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Melanoma

Interventions

Anti-PD-1 monoclonal antibody

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2021Actual

Primary Completion Date

May 11, 2021Actual

Completion Date

Mar 25, 2023Estimated

First Submitted Date

Jun 7, 2021

First Submission Date that Met QC Criteria

Jun 13, 2021

First Posted Date

Jun 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2021

Last Update Posted Date

Jun 16, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Advanced melanoma patients	Other		Drug: Anti-PD-1 monoclonal antibody
Stage III and IV melanoma patients after radical surgery	Other		Drug: Anti-PD-1 monoclonal antibody

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-PD-1 monoclonal antibody	Drug	Anti-PD-1 therapy	Advanced melanoma patients Stage III and IV melanoma patients after radical surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival		up to 12 months
Progression free survival		up to 12 months

Secondary Outcomes

Measure	Description	Time Frame
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	up to 12 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Irina N Mikhaylova, DSc	Contact	8 499 324 90 24		irmikhaylova@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
N.N. Blokhin Russian Cancer Research Center, Kashirskoye shosse 23	Recruiting	Moscow		115478	Russia

Condition Browse Module

MeSH Terms

ID	Term
D008545	Melanoma

Ancestor Terms

ID	Term
D018358	Neuroendocrine Tumors
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided