Inflammatory Markers (ICC, MCVL) and Nivolumab Response: Predicting Immunotherapy Success in Metastatic RCC (IMNR)

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.

The primary endpoints of the study are as follows:

1. Progression-Free Survival (PFS): To determine how long nivolumab treatment can halt disease progression.
2. Overall Survival (OS): To assess the overall survival of participants following treatment.
3. 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.

Study Overview

• Status: Completed
• Conditions: Metastatic Renal Cell Carcinoma

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 Type: Observational
• Enrollment (Actual): 99

Contacts and Locations

Study Locations

• Turkey
  • Kartal
    • Istanbul, Kartal, Turkey, 34865
      • Health Science University Kartal Dr. Lütfi Kirdar City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival	Progression-free survival (PFS) was assessed to determine if the disease had progressed, using disease control rates as a reference.	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.	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.	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.	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.	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.	12th month
Overall Survival	Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.	3rd month
Overall Survival	Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.	6th month
Overall Survival	Overall Survival (OS) was assessed to evaluate the survival status of the patients following treatment initiation.	12th month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Inflammatory Markers (ICC)	Inflammatory markers (ICC) will be regularly monitored, and any changes in these markers during treatment will be evaluated.	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.	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.	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.	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.	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.	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.	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.	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.	12th month
Response Based on Metastatic Sites	The response to treatment in different metastatic sites (lungs, bones, brain, etc.) will be evaluated.	3rd month
Response Based on Metastatic Sites	The response to treatment in different metastatic sites (lungs, bones, brain, etc.) will be evaluated.	6th month
Response Based on Metastatic Sites	The response to treatment in different metastatic sites (lungs, bones, brain, etc.) will be evaluated.	12th month
Evaluation of Neutrophil-Lymphocyte Ratio	other blood parameters ( Neutrophil-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.	3rd month
Evaluation of Neutrophil-Lymphocyte Ratio	other blood parameters ( Neutrophil-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.	6th month
Evaluation of Neutrophil-Lymphocyte Ratio	other blood parameters (Neutrophil-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.	12th month
Evaluation of Platelet-Lymphocyte Ratio	other blood parameters (Platelet-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.	3rd month
Evaluation of Platelet-Lymphocyte Ratio	other blood parameters (Platelet-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.	6th month
Evaluation of Platelet-Lymphocyte Ratio	other blood parameters (Platelet-Lymphocyte Ratio) will be analyzed for their potential to predict treatment success.	12th month

Collaborators and Investigators

• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
• Investigators: Principal Investigator: Heves Surmeli, MD, Health University Kartal Dr. Lütfi Kirdar City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2024

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 4, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Nivolumab; ICC; RCC; inflammatory marker; MCVL
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma
• Other Study ID Numbers: 2024/010.99/6/9

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No