MelanomaICIPRESIST19NCT04025424
Genetic Predictors of Efficiency and Safety of ICIs in Patients With Different Malignancies (ICIPRESIST-0519)
An observational study of Melanoma and Squamous Cell Lung Cancer, run by Russian Academy of Medical Sciences at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Squamous Cell Lung Cancer, Uveal Melanoma
- What is being tested?
- Genetic tests of the available tumor and plasma samples
- How many people
- 350 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jun 2019to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target sample consists of approximately 350 treated patients, treatment of patients with melanoma, squamous cell lung cancer in the late stages (inoperable or metastatic) and Hodgkin dsisease, who met the criteria. The current study will be conducted in selected research centers where at least 5 patients are treated with blockers of immune checkpoints during the quarter (3 months) in the period from 2015 to 2019. In each research center, patients will be identified that meet the inclusion criteria, based on the lists of patients who received therapy with blockers of immune checkpoints in specific research centers. The study is conducted only in centers located in Russia.
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
N.N. Blokhin Russian Cancer Research Center
Moscow, Moscow, 115478
Igor Samoylenko, MD, PhD, +79099729384, i.samoylenko@ronc.ru
Kirill Baryshnikov, MD, PhD, +79671751112, k.baryshnikov@ronc.ru
About this study
Official title: Observational Study of Genetic Predictors of Efficiency and Safety of Immune Checkpoints Inhibitors in Patients With Different Malignancies (ICIPRESIST-0519)
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.
- Conditions
- Melanoma, Squamous Cell Lung Cancer, Uveal Melanoma, Hodgkin Lymphoma
- Being tested
- Genetic tests of the available tumor and plasma samples
- Medical subject headings
- Melanoma, Uveal Melanoma, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic tests of the available tumor and plasma samplesGenetic
Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned
| Study group | Role | What they receive |
|---|---|---|
| Skin melanoma, retrospective | * 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; Receives: Genetic: Genetic tests of the available tumor and plasma samples | |
| Hodgkin 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; Receives: Genetic: Genetic tests of the available tumor and plasma samples | |
| Uveal melanoma, retrospective | * 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 il Receives: Genetic: Genetic tests of the available tumor and plasma samples | |
| Skin melanoma, proscpective | * 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; Receives: Genetic: Genetic tests of the available tumor and plasma samples | |
| Lung cancer, procpective | * 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; Receives: Genetic: Genetic tests of the available tumor and plasma samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: dec 2021
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.
Measured: dec 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start15 Jun 2019
- Primary completion30 Jun 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Igor Samoylenko, Russian Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025424
- Sponsor's protocol ID
- ICIPRESIST-052019
- Acronym
- ICIPRESIST19
- Status last verified
- Dec 2021
- First submitted
- 17 Jul 2019
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Genetic Predictors of Efficiency and Safety of Immune Checkpoints Inhibitors in Patients With Different Malignancies (ICIPRESIST-0519)
- ClinicalTrials.gov ID
- NCT04025424
- Acronym / sponsor ID
- ICIPRESIST19 / ICIPRESIST-052019
- Conditions
- Melanoma, Squamous Cell Lung Cancer, Uveal Melanoma, Hodgkin Lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Russian Academy of Medical SciencesUniversity, hospital or other
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Skin melanoma, retrospective | – | Genetic: Genetic tests of the available tumor and plasma samples* 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; |
| Hodgkin disease, retrospective | – | Genetic: Genetic tests of the available tumor and plasma samples* 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; |
| Uveal melanoma, retrospective | – | Genetic: Genetic tests of the available tumor and plasma samples* 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 il |
| Skin melanoma, proscpective | – | Genetic: Genetic tests of the available tumor and plasma samples* 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; |
| Lung cancer, procpective | – | Genetic: Genetic tests of the available tumor and plasma samples* 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; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target sample consists of approximately 350 treated patients, treatment of patients with melanoma, squamous cell lung cancer in the late stages (inoperable or metastatic) and Hodgkin dsisease, who met the criteria. The current study will be conducted in selected research centers where at least 5 patients are treated with blockers of immune checkpoints during the quarter (3 months) in the period from 2015 to 2019. In each research center, patients will be identified that meet the inclusion criteria, based on the lists of patients who received therapy with blockers of immune checkpoints in specific research centers. The study is conducted only in centers located in Russia.
Key inclusion criteria (41 listed)
- 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
- Cohort 1 (retrospective cohort of skin melanoma patients)
- Cohort 2 (Hodjkin disease - retrospective)
- Cohort 3 (Uveal melanoma - retro)
Key exclusion criteria (12 listed)
- Cohort 1 (retrospective cohort of skin melanoma patients)
- Cohort 2 (Hodgkin disease - retrospective)
- no special exclusion criteria
- Cohort 3 (Uveal melanoma - retro)
- Cohort 4 (melanoma of the skin - prospective)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic tests of the available tumor and plasma samplesOnly available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned | Genetic | Hodgkin disease, retrospective, Lung cancer, procpective, Skin melanoma, proscpective, Skin melanoma, retrospective, Uveal melanoma, retrospective |
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma and Squamous Cell Lung Cancer, run by Russian Academy of Medical Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 41 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Igor Samoylenko, MD, PhD (+79099729384, i.samoylenko@ronc.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.