Metastatic Renal Cell CarcinomaIMNRNCT06607809
Inflammatory Markers (ICC, MCVL) and Nivolumab Response: Predicting Immunotherapy Success in Metastatic RCC
An observational study of Metastatic Renal Cell Carcinoma, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study is an observational study aimed at investigating the potential of new inflammatory markers to predict treatment response in patients with metastatic renal cell carcinoma (mRCC) undergoing anti-PD-1 antibody nivolumab therapy. Read more about this study
- Who is it for?
- Ages 19 to 87 years
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jan 2024
- 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 19 to 87 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 and older diagnosed with metastatic renal cell carcinoma (mRCC). All participants are receiving nivolumab, an anti-PD-1 antibody, as part of their treatment for metastatic disease. Most patients have clear cell carcinoma, though other subtypes like papillary and sarcomatoid carcinoma are included.Patients have metastases in organs such as the lungs, bones, brain, and liver. The study monitors inflammatory markers, including the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL), at key time points. These biomarkers are evaluated for their role in predicting treatment response and disease progression, focusing on progression-free survival and overall survival in this population.
Who may be able to join
- Age: Participants must be ≥18 and ≤87 years old. Diagnosis: Patients must have been diagnosed with metastatic renal cell carcinoma (mRCC).
- Treatment: Only patients receiving nivolumab treatment for metastatic renal cell carcinoma are included.
- Consent: Written informed consent was obtained from all participants
Who cannot join
- Other Active Cancers: Patients with concurrent active malignancies were excluded from the study.
- Prior Immunotherapy Treatment: Patients who had previously received any form of immunotherapy (anti-PD-1, anti-PD-L1, or similar immunological agents) were excluded.
- Uncontrolled Systemic Diseases: Patients with severe, uncontrolled systemic diseases (e.g., significant cardiovascular, pulmonary, or liver diseases) were not included in the study.
- Active Infections: Patients with serious active infections, such as active tuberculosis, HIV infection, or chronic hepatitis B or C, were excluded.
- Pregnancy and Breastfeeding: Pregnant or breastfeeding women were not eligible for inclusion in the study.
- Immunodeficiency or Immunosuppressive Therapy: Patients with immunodeficiency or those receiving immunosuppressive therapy (e.g., corticosteroids) were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Kartal Dr. Lütfi Kirdar City Hospital
Istanbul, Kartal, 34865
About this study
Official title: Association of Inflammatory Markers (ICC, MCVL) With Anti PD-1 Antibody Nivolumab Response: Evaluating Biomarkers for Predicting Immunotherapy Success in Patients With Metastatic Renal Cell Carcinoma
This study is an observational study aimed at investigating the potential of new inflammatory markers to predict treatment response in patients with metastatic renal cell carcinoma (mRCC) undergoing anti-PD-1 antibody nivolumab therapy. Specifically, the study focuses on evaluating how well the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL) can predict the response to nivolumab treatment and the progression of the disease.
The participant group consists of patients aged 18 and older who have been diagnosed with metastatic renal cell carcinoma. Inflammatory markers were monitored at regular intervals throughout the treatment period.
Read more
The primary endpoints of the study are as follows:
- Progression-Free Survival (PFS): To determine how long nivolumab treatment can halt disease progression.
- Overall Survival (OS): To assess the overall survival of participants following treatment.
- Disease Control Rate (DCR): To evaluate the disease control rates (stable disease, partial response, complete response) at 3, 6, and 12 months of Nivolumab treatment.
This study aims to deeply analyze the impact of inflammatory markers such as ICC and MCVL on disease progression and treatment response, determining to what extent these markers serve as predictors of treatment success. Additionally, it explores how these markers can be utilized in personalized treatment strategies to improve therapeutic outcomes.
Read the detailed description
This observational study investigates the potential of new inflammatory markers to predict treatment response in patients with metastatic renal cell carcinoma (mRCC) undergoing anti-PD-1 antibody nivolumab therapy. The study specifically aims to evaluate how well the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL) can predict the response to nivolumab treatment and the progression of the disease.
Detailed Characteristics of the Participants:
Age Range: The participants cover a wide age range, from young adults to elderly individuals.
Gender and General Health Status: The gender of the participants is not specified, but all participants are adults diagnosed with metastatic renal cell carcinoma. Most have previously undergone treatment for renal cancer, and their disease has metastasized.
Histological Subtypes: The majority of participants have clear cell renal cell carcinoma (clear cell RCC). Other histological subtypes, including papillary, chromophobe, and sarcomatoid types, are also represented.
Metastasis Status: A significant proportion of the participants show metastasis to multiple organs. These metastases are most commonly found in the lungs, bones, brain, and liver.
Blood Parameters: Throughout the treatment, the blood values of the participants were regularly monitored. These parameters include white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), platelets (PLT), neutrophils, and lymphocytes.
Inflammatory Markers: The study tracks inflammatory markers such as the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL) in participants. These markers are believed to play an important role in the progression of the disease and the response to treatment.
Primary Endpoints of the Study:
Progression-Free Survival (PFS): The ability of nivolumab treatment to halt the progression of the disease over time is assessed.
Overall Survival (OS): The overall survival of participants following treatment is analyzed.
Disease Control Rate (DCR): The disease control rates (stable disease, partial response, complete response) at various time points during nivolumab treatment are evaluated.
Study Objective:
The primary aim of this study is to analyze the impact of inflammatory markers such as ICC and MCVL on disease progression and treatment response. Additionally, it seeks to explore how these markers can predict treatment success and be used in personalized treatment strategies.
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- RCC, Nivolumab, inflammatory marker, ICC, MCVL
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Progression-free survival (PFS) was assessed to determine if the disease had progressed, using disease control rates as a reference.
Measured: 3rd Month
Progression-Free Survival
Progression-free survival (PFS) was assessed to determine if the disease had progressed, using disease control rates as a reference.
Measured: 6th Month
Progression-Free Survival
Progression-free survival (PFS) was assessed to determine if the disease had progressed, using disease control rates as a reference.
Measured: 12th Month
Disease Control Rate (DCR)
The disease control rate (DCR) was evaluated to assess the response to treatment, including the rates of stable disease, partial response, and complete response.
Measured: 3rd month
Disease Control Rate (DCR)
The disease control rate (DCR) was evaluated to assess the response to treatment, including the rates of stable disease, partial response, and complete response.
Measured: 6th month
Disease Control Rate (DCR)
The disease control rate (DCR) was evaluated to assess the response to treatment, including the rates of stable disease, partial response, and complete response.
Measured: 12th month
Overall Survival
Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.
Measured: 3rd month
Overall Survival
Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.
Measured: 6th month
Overall Survival
Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.
Measured: 12th month
Secondary outcomes (18)
Changes in Inflammatory Markers (ICC)
Inflammatory markers (ICC) will be regularly monitored, and any changes in these markers during treatment will be evaluated.
Measured: 3rd month
Changes in Inflammatory Markers (ICC)
Inflammatory markers (ICC) will be regularly monitored, and any changes in these markers during treatment will be evaluated.
Measured: 6th month
Changes in Inflammatory Markers (ICC)
Inflammatory markers (ICC) will be regularly monitored, and any changes in these markers during treatment will be evaluated.
Measured: 12th month
Changes in Inflammatory Markers (MCVL)
Inflammatory markers (MCVL) will be regularly monitored, and any changes in these markers during treatment will be evaluated.
Measured: 3rd month
Changes in Inflammatory Markers (MCVL)
Inflammatory markers (MCVL) will be regularly monitored, and any changes in these markers during treatment will be evaluated.
Measured: 6th month
Changes in Inflammatory Markers (MCVL)
Inflammatory markers (MCVL) will be regularly monitored, and any changes in these markers during treatment will be evaluated.
Measured: 12th month
Immune-related adverse events (irAEs)
Immune-related adverse events (irAEs) will be tracked, and the frequency and severity of these side effects will be assessed.
Measured: 3rd month
Immune-related adverse events (irAEs)
Immune-related adverse events (irAEs) will be tracked, and the frequency and severity of these side effects will be assessed.
Measured: 6th month
Immune-related adverse events (irAEs)
Immune-related adverse events (irAEs) will be tracked, and the frequency and severity of these side effects will be assessed.
Measured: 12th month
Response Based on Metastatic Sites
The response to treatment in different metastatic sites (lungs, bones, brain, etc.) will be evaluated.
Measured: 3rd month
Response Based on Metastatic Sites
The response to treatment in different metastatic sites (lungs, bones, brain, etc.) will be evaluated.
Measured: 6th month
Response Based on Metastatic Sites
The response to treatment in different metastatic sites (lungs, bones, brain, etc.) will be evaluated.
Measured: 12th month
Evaluation of Neutrophil-Lymphocyte Ratio
other blood parameters ( Neutrophil-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.
Measured: 3rd month
Evaluation of Neutrophil-Lymphocyte Ratio
other blood parameters ( Neutrophil-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.
Measured: 6th month
Evaluation of Neutrophil-Lymphocyte Ratio
other blood parameters (Neutrophil-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.
Measured: 12th month
Evaluation of Platelet-Lymphocyte Ratio
other blood parameters (Platelet-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.
Measured: 3rd month
Evaluation of Platelet-Lymphocyte Ratio
other blood parameters (Platelet-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.
Measured: 6th month
Evaluation of Platelet-Lymphocyte Ratio
other blood parameters (Platelet-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.
Measured: 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Feb 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heves Sürmeli, Dr. Lutfi Kirdar Kartal Training and Research Hospital
- Investigators
- Heves Surmeli, MD, Principal investigator, Health University Kartal Dr. Lütfi Kirdar City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607809
- Sponsor's protocol ID
- 2024/010.99/6/9
- Acronym
- IMNR
- Status last verified
- Oct 2024
- First submitted
- 19 Sep 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Inflammatory Markers (ICC, MCVL) With Anti PD-1 Antibody Nivolumab Response: Evaluating Biomarkers for Predicting Immunotherapy Success in Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06607809
- Acronym / sponsor ID
- IMNR / 2024/010.99/6/9
- Conditions
- Metastatic Renal Cell Carcinoma
- Keywords
- RCC, Nivolumab, inflammatory marker, ICC, MCVL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Dr. Lutfi Kirdar Kartal Training and Research HospitalOther government
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 23 Sep 2024 (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 study is an observational study aimed at investigating the potential of new inflammatory markers to predict treatment response in patients with metastatic renal cell carcinoma (mRCC) undergoing anti-PD-1 antibody nivolumab therapy. Specifically, the study focuses on evaluating how well the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL) can predict the response to nivolumab treatment and the progression of the disease.
The participant group consists of patients aged 18 and older who have been diagnosed with metastatic renal cell carcinoma. Inflammatory markers were monitored at regular intervals throughout the treatment period.
The primary endpoints of the study are as follows:
- Progression-Free Survival (PFS): To determine how long nivolumab treatment can halt disease progression.
- Overall Survival (OS): To assess the overall survival of participants following treatment.
- Disease Control Rate (DCR): To evaluate the disease control rates (stable disease, partial response, complete response) at 3, 6, and 12 months of Nivolumab treatment.
This study aims to deeply analyze the impact of inflammatory markers such as ICC and MCVL on disease progression and treatment response, determining to what extent these markers serve as predictors of treatment success. Additionally, it explores how these markers can be utilized in personalized treatment strategies to improve therapeutic outcomes.
Detailed description
This observational study investigates the potential of new inflammatory markers to predict treatment response in patients with metastatic renal cell carcinoma (mRCC) undergoing anti-PD-1 antibody nivolumab therapy. The study specifically aims to evaluate how well the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL) can predict the response to nivolumab treatment and the progression of the disease.
Detailed Characteristics of the Participants:
Age Range: The participants cover a wide age range, from young adults to elderly individuals.
Gender and General Health Status: The gender of the participants is not specified, but all participants are adults diagnosed with metastatic renal cell carcinoma. Most have previously undergone treatment for renal cancer, and their disease has metastasized.
Histological Subtypes: The majority of participants have clear cell renal cell carcinoma (clear cell RCC). Other histological subtypes, including papillary, chromophobe, and sarcomatoid types, are also represented.
Metastasis Status: A significant proportion of the participants show metastasis to multiple organs. These metastases are most commonly found in the lungs, bones, brain, and liver.
Blood Parameters: Throughout the treatment, the blood values of the participants were regularly monitored. These parameters include white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), platelets (PLT), neutrophils, and lymphocytes.
Inflammatory Markers: The study tracks inflammatory markers such as the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL) in participants. These markers are believed to play an important role in the progression of the disease and the response to treatment.
Primary Endpoints of the Study:
Progression-Free Survival (PFS): The ability of nivolumab treatment to halt the progression of the disease over time is assessed.
Overall Survival (OS): The overall survival of participants following treatment is analyzed.
Disease Control Rate (DCR): The disease control rates (stable disease, partial response, complete response) at various time points during nivolumab treatment are evaluated.
Study Objective:
The primary aim of this study is to analyze the impact of inflammatory markers such as ICC and MCVL on disease progression and treatment response. Additionally, it seeks to explore how these markers can predict treatment success and be used in personalized treatment strategies.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 87 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 and older diagnosed with metastatic renal cell carcinoma (mRCC). All participants are receiving nivolumab, an anti-PD-1 antibody, as part of their treatment for metastatic disease. Most patients have clear cell carcinoma, though other subtypes like papillary and sarcomatoid carcinoma are included.Patients have metastases in organs such as the lungs, bones, brain, and liver. The study monitors inflammatory markers, including the Cumulative Inflammatory Index (ICC) and Mean Corpuscular Volume/Lymphocyte Ratio (MCVL), at key time points. These biomarkers are evaluated for their role in predicting treatment response and disease progression, focusing on progression-free survival and overall survival in this population.
Key inclusion criteria (3 listed)
- Age: Participants must be ≥18 and ≤87 years old. Diagnosis: Patients must have been diagnosed with metastatic renal cell carcinoma (mRCC).
- Treatment: Only patients receiving nivolumab treatment for metastatic renal cell carcinoma are included.
- Consent: Written informed consent was obtained from all participants
Key exclusion criteria (6 listed)
- Other Active Cancers: Patients with concurrent active malignancies were excluded from the study.
- Prior Immunotherapy Treatment: Patients who had previously received any form of immunotherapy (anti-PD-1, anti-PD-L1, or similar immunological agents) were excluded.
- Uncontrolled Systemic Diseases: Patients with severe, uncontrolled systemic diseases (e.g., significant cardiovascular, pulmonary, or liver diseases) were not included in the study.
- Active Infections: Patients with serious active infections, such as active tuberculosis, HIV infection, or chronic hepatitis B or C, were excluded.
- Pregnancy and Breastfeeding: Pregnant or breastfeeding women were not eligible for inclusion in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival
Time frame: 3rd Month
Progression-free survival (PFS) was assessed to determine if the disease had progressed, using disease control rates as a reference.
Progression-Free Survival
Time frame: 6th Month
Progression-free survival (PFS) was assessed to determine if the disease had progressed, using disease control rates as a reference.
Progression-Free Survival
Time frame: 12th Month
Progression-free survival (PFS) was assessed to determine if the disease had progressed, using disease control rates as a reference.
Disease Control Rate (DCR)
Time frame: 3rd month
The disease control rate (DCR) was evaluated to assess the response to treatment, including the rates of stable disease, partial response, and complete response.
Disease Control Rate (DCR)
Time frame: 6th month
The disease control rate (DCR) was evaluated to assess the response to treatment, including the rates of stable disease, partial response, and complete response.
Disease Control Rate (DCR)
Time frame: 12th month
The disease control rate (DCR) was evaluated to assess the response to treatment, including the rates of stable disease, partial response, and complete response.
Overall Survival
Time frame: 3rd month
Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.
Overall Survival
Time frame: 6th month
Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.
Overall Survival
Time frame: 12th month
Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.
18 secondary outcomes
Changes in Inflammatory Markers (ICC)
Time frame: 3rd month
Changes in Inflammatory Markers (ICC)
Time frame: 6th month
Changes in Inflammatory Markers (ICC)
Time frame: 12th month
Changes in Inflammatory Markers (MCVL)
Time frame: 3rd month
Changes in Inflammatory Markers (MCVL)
Time frame: 6th month
Changes in Inflammatory Markers (MCVL)
Time frame: 12th month
Immune-related adverse events (irAEs)
Time frame: 3rd month
Immune-related adverse events (irAEs)
Time frame: 6th month
Immune-related adverse events (irAEs)
Time frame: 12th month
Response Based on Metastatic Sites
Time frame: 3rd month
Response Based on Metastatic Sites
Time frame: 6th month
Response Based on Metastatic Sites
Time frame: 12th month
Evaluation of Neutrophil-Lymphocyte Ratio
Time frame: 3rd month
Evaluation of Neutrophil-Lymphocyte Ratio
Time frame: 6th month
Evaluation of Neutrophil-Lymphocyte Ratio
Time frame: 12th month
Evaluation of Platelet-Lymphocyte Ratio
Time frame: 3rd month
Evaluation of Platelet-Lymphocyte Ratio
Time frame: 6th month
Evaluation of Platelet-Lymphocyte Ratio
Time frame: 12th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
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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.
Heves Surmeli, MD principal investigator
Health University Kartal Dr. Lütfi Kirdar City Hospital
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 Metastatic Renal Cell Carcinoma, run by Dr. Lutfi Kirdar Kartal Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 8 Oct 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (time frame: 3rd Month). The study lists 9 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 8 Oct 2024.