Observational Study of Genetic Predictors of Efficiency and Safety of Immune Checkpoints Inhibitors in Patients With Different Malignancies (ICIPRESIST-0519)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- Russian Academy of Medical Sciences
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- 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
- Last Updated
- 4 years ago
Overview
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.
Investigators
Igor Samoylenko
MD, PhD, Principal Investigator, Senior Researcher, Tumor biotherpay Department
Russian Academy of Medical Sciences
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)
- •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;
Exclusion Criteria
- •Cohort 1 (retrospective cohort of skin melanoma patients)
- •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)
- •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
- •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)
Outcomes
Primary Outcomes
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
Time Frame: dec 2021
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.
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.
Time Frame: dec 2021