Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519)

NCT04025424 | Unknown

• 1 other identifier: ICIPRESIST-052019
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, non-interventional, retrospective study (with two prospective cohorts), including previously treated patients with melanoma, squamous cell lung cancer in the late stages (inoperable or metastatic) and Hodgkin disease at any stages. The duration of the follow-up will be 12-60 months. Data from medical records will be retrospectively collected at different points in time. The first data extraction will consist of collecting data from the initial level (before treatment with immune checkpoints inhibitors (anti-PD1 / PDl1) before the end of the recruitment period for this study (up to 3 years of follow-up). Two additional annual data collections are planned for display additional follow-up and data for patients who will survive.

Conditions

Melanoma; Squamous Cell Lung Cancer; Uveal Melanoma; Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (2)

• overall survival (OS) of patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and lymphoma granulomatosis

  Overall survival (OS) will be calculated and presented in graphical form using the method of the product of Kaplan-Meier limits. The report will include a median of C with corresponding bilateral values of 95% CI. The proportion of patients who survive at certain points in time (1, 2, and 3 years), as well as the corresponding bilateral values of 95% CI, will be evaluated and reported.

  dec 2021

• incidence and severity of all adverse events (AEs) in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and lymphoma.

  dec 2021

Other Outcomes (3)

• progression-free survival (PFS) in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and Hodgkin disease

  dec 2021

• response rate in patients receiving immune checkpoint blockers (PD1 / PDl1 blockers) in the first and subsequent treatment lines in patients with metastatic or unresectable melanoma, lung cancer and Hodgkin disease

  dec 2021

• Development of predictive molecular testing tools

  dec 2021

Study Arms (5)

Skin melanoma, retrospective

* 1\) Clinically and morphologically verified diagnosis of skin melanoma or melanoma metastases without an identified primary lesion; * 2\) The availability of basic clinical information about the patient and the course of his illness;

Genetic: Genetic tests of the available tumor and plasma samples

Hodgkin disease, retrospective

* 1\) Clinically and morphologically verified diagnosis of Hodgkin disease (any histological variant); * 2\) The availability of basic clinical information about the patient and the course of his illness;

Genetic: Genetic tests of the available tumor and plasma samples

Uveal melanoma, retrospective

* 1\) Clinically and morphologically verified diagnosis of uveal melanoma (any histological variant); * 2\) The availability of basic clinical information about the patient and the course of his il

Genetic: Genetic tests of the available tumor and plasma samples

Skin melanoma, proscpective

* 1\) Clinically and morphologically verified diagnosis of metastatic melanoma; * 2\) The availability of basic clinical information about the patient and the course of his illness;

Genetic: Genetic tests of the available tumor and plasma samples

Lung cancer, procpective

* 1\) Clinically and morphologically verified diagnosis of metastatic or inoperable squamous cell lung cancer; * 2\) The availability of basic clinical information about the patient and the course of his illness; * 3\) The presence of indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy;

Genetic: Genetic tests of the available tumor and plasma samples

Interventions

Genetic tests of the available tumor and plasma samples GENETIC

Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned

Hodgkin disease, retrospective; Lung cancer, procpective; Skin melanoma, proscpective; Skin melanoma, retrospective; Uveal melanoma, retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target sample consists of approximately 350 treated patients, treatment of patients with melanoma, squamous cell lung cancer in the late stages (inoperable or metastatic) and Hodgkin dsisease, who met the criteria. The current study will be conducted in selected research centers where at least 5 patients are treated with blockers of immune checkpoints during the quarter (3 months) in the period from 2015 to 2019. In each research center, patients will be identified that meet the inclusion criteria, based on the lists of patients who received therapy with blockers of immune checkpoints in specific research centers. The study is conducted only in centers located in Russia.

You may qualify if:

• To participate in this study, the patient must meet the following criteria:
• At least 2 injections (or 10 weeks) of ICI (PD1, PDl1 blockers, including but not limited to such drugs as nivolumab, pembrolizumab, prolglimab, atezolizumab, avelumab, durvalumab, spratalizumab)
• Deceased patients meet the criteria; signing the informed consent of the legal representative of the deceased patient is not required
• Cohort 1 (retrospective cohort of skin melanoma patients)
• \) Clinically and morphologically verified diagnosis of skin melanoma or melanoma metastases without an identified primary focus;
• \) The availability of basic clinical information about the patient and the course of his illness;
• \) Therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy (at least 2 injections);
• \) Evaluation of the effect of immunotherapy
• \) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies, obtained no earlier than 24 months. before initiating therapy with a PD-1 or PD-L1 inhibitor;
• \) Patient-signed informed consent in case the patient is alive
• Cohort 2 (Hodjkin disease - retrospective)
• \) Clinically and morphologically verified diagnosis of Hodgkin disease (any histological variant);
• \) The availability of basic clinical information about the patient and the course of his illness;
• \) Availability of tumor material (paraffin blocks) for morphological, immunohistochemical and molecular genetic studies;
• \) Patient signed informed consent.

You may not qualify if:

• Cohort 1 (retrospective cohort of skin melanoma patients)
• \- 1) It is not allowed to conduct other immunotherapy (anti-CTLA4, vaccines, etc.) to patients before the course of therapy with a PD-1 or PD-L1 inhibitor in a standard dosage in monotherapy
• Cohort 2 (Hodgkin disease - retrospective)
• Cohort 3 (Uveal melanoma - retro)
• Cohort 4 (melanoma of the skin - prospective)
• \) It is not allowed to include patients who have previously undergone other immunotherapy (anti-CTLA4, vaccines, etc.) before the course of therapy with the PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy
• Cohort 5 (squamous cell lung cancer - prospective)
• \) It is not allowed to include patients who have previously undergone other immunotherapy (anti-CTLA4, vaccines, etc.) before the course of therapy with the PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead

Study Sites (1)

N.N. Blokhin Russian Cancer Research Center

Moscow, Moscow, 115478, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor blocks and blood DNA

MeSH Terms

Conditions

Melanoma; Uveal Melanoma; Hodgkin Disease

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases; Lymphoma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Igor Samoylenko, MD, PhD

CONTACT

+79099729384; i.samoylenko@ronc.ru

Irina Mikhaylova, MD, PhD

CONTACT

+74993249034; i.mikhaylova@ronc.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Principal Investigator, Senior Researcher, Tumor biotherpay Department

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 18, 2019
• Study Start: June 15, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 1, 2023
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

RU (1)