Status:
UNKNOWN
Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519)
Lead Sponsor:
Russian Academy of Medical Sciences
Conditions:
Melanoma
Squamous Cell Lung Cancer
Eligibility:
All Genders
18+ years
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 (inoper...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04025424
Start Date
June 15 2019
End Date
December 1 2023
Last Update
December 28 2021
Active Locations (1)
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1
N.N. Blokhin Russian Cancer Research Center
Moscow, Moscow, Russia, 115478