NCT06607809

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 99 (actual)
• Sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital · Other Government
• Sex: All
• Age: 19 Years – 87 Years
• Healthy volunteers: Not accepted

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. 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.

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

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-01-01
• Completion: 2024-01-01
• First posted: 2024-09-23
• Last updated: 2024-10-08

Locations

1 site across 1 country: Turkey (Türkiye)