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

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.