NCT04928365

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2021

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 16, 2021

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2023

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 7, 2021

Last Update Submit

June 13, 2021

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    up to 12 months

  • Progression free survival

    up to 12 months

Secondary Outcomes (1)

  • Cytokine profile

    up to 12 months

Study Arms (2)

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

Anti-PD-1 monoclonal antibodyDRUG

Anti-PD-1 therapy

Advanced melanoma patientsStage III and IV melanoma patients after radical surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 115478, Russia

RECRUITING

MeSH Terms

Conditions

Melanoma

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Irina N Mikhaylova, DSc

CONTACT

8 499 324 90 24irmikhaylova@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 7, 2021

First Posted

June 16, 2021

Study Start

March 25, 2021

Primary Completion

May 11, 2021

Study Completion

March 25, 2023

Last Updated

June 16, 2021

Record last verified: 2021-06

Locations

RU(1)