Brief Title
Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519)
Official Title
Observational Study of Genetic Predictors of Efficiency and Safety of Immune Checkpoints Inhibitors in Patients With Different Malignancies (ICIPRESIST-0519)
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.
Study Type
Observational
Primary Outcome
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
Condition
Melanoma
Intervention
Genetic tests of the available tumor and plasma samples
Study Arms / Comparison Groups
Skin melanoma, retrospective
Description: 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;
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Genetic
Estimated Enrollment
350
Start Date
June 15, 2019
Completion Date
December 1, 2022
Primary Completion Date
June 30, 2021
Eligibility Criteria
Inclusion Criteria:
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
Specific inclusion criteria for individual cohorts:
- Cohort 1 (retrospective cohort of skin melanoma patients)
- 1) Clinically and morphologically verified diagnosis of skin melanoma or melanoma
metastases without an identified primary focus;
- 2) The availability of basic clinical information about the patient and the
course of his illness;
- 3) Therapy with a PD-1 or PD-L1 inhibitor in the standard dosage in monotherapy
(at least 2 injections);
- 4) Evaluation of the effect of immunotherapy
- 5) 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;
- 8) Patient-signed informed consent in case the patient is alive
- Cohort 2 (Hodjkin 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;
- 3) Availability of tumor material (paraffin blocks) for morphological,
immunohistochemical and molecular genetic studies;
- 4) Patient signed informed consent.
- Cohort 3 (Uveal melanoma - retro)
- 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 illness;
- 3) Availability of tumor material (paraffin blocks) for morphological,
immunohistochemical and molecular genetic studies;
- 4) Patient signed informed consent.
- Cohort 4 (melanoma of the skin - prospective)
- 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;
- 3) Indications for therapy with a PD-1 or PD-L1 inhibitor in the standard dosage
in monotherapy;
- 4) The possibility of including the patient in the present study before the first
course of immunotherapy;
- 5) Availability of tumor material (paraffin blocks and histological glass
preparations) for morphological, immunohistochemical and molecular genetic
studies obtained no earlier than 2 years before the planned start of
immunotherapy with a standard PD-1 inhibitor;
- 6) Separate patient consent to a repeated biopsy of the tumor focus before the
planned start of immunotherapy with a PD-1 or PD-L1 inhibitor, if the existing
tumor material was obtained earlier than 2 years before the planned start of
immunotherapy
- 7) Availability of samples of biological fluids collected before the start of
immunotherapy and after the first course of immunotherapy for molecular genetic
studies of circulating tumor DNA;
- 8) Evaluation of the effect of therapy in the framework of local practice in
accordance with the criteria of RECIST 1.1
- 9) Signed by the patient informed consent to participate in the study.
- Cohort 5 (squamous cell lung cancer - prospective)
- 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;
- 4) The possibility of including the patient in the present study before the first
course of immunotherapy;
- 5) Availability of tumor material (paraffin blocks) for morphological,
immunohistochemical and molecular genetic research, obtained no earlier than 2
years before the planned start of immunotherapy with a standard PD-1 inhibitor;
- 6) Separate patient consent to a repeated biopsy of the tumor focus before the
planned start of immunotherapy with a PD-1 or PD-L1 inhibitor, if the existing
tumor material was obtained earlier than 2 years before the planned start of
immunotherapy
- 7) Availability of samples of biological fluids collected before the start of
immunotherapy and after the first course of immunotherapy for molecular genetic
studies of circulating tumor DNA;
- 8) Evaluation of the effect of therapy in the framework of local practice in
accordance with the criteria of RECIST 1.1
- 9) Signed by the patient informed consent to participate in the study.
Exclusion Criteria:
- 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)
- no special exclusion criteria
- Cohort 3 (Uveal melanoma - retro)
- No special exclusion criteria.
- Cohort 4 (melanoma of the skin - prospective)
- 1) 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
- 2) It is not allowed to include patients who are scheduled for combination
immunotherapy (anti-PD1 + anti-CTLA4, vaccines, etc.) after inclusion in this
study
- Cohort 5 (squamous cell lung cancer - prospective)
- 1) 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
- 2) It is not allowed to include patients who are scheduled for combination
immunotherapy (anti-PD1 + anti-CTLA4, vaccines, etc.) after inclusion in this
study.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, +79099729384, [email protected]
Location Countries
Russian Federation
Location Countries
Russian Federation
Administrative Informations
NCT ID
NCT04025424
Organization ID
ICIPRESIST-052019
Responsible Party
Principal Investigator
Study Sponsor
Russian Academy of Medical Sciences
Study Sponsor
, ,
Verification Date
September 2019