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

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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