Clinical trial NCT06607809: Inflammatory Markers (ICC, MCVL) and Nivolumab Response: Predicting Immunotherapy Success in Metastatic RCC
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Keywords: RCC
Nivolumab
inflammatory marker
ICC
MCVL
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-09-23
Enrollment: 99
Sex: ALL
Minimum age (years): 19
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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.

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival
timeFrame: 3rd Month
measure: Progression-Free Survival
timeFrame: 6th Month
measure: Progression-Free Survival
timeFrame: 12th Month
measure: Disease Control Rate (DCR)
timeFrame: 3rd month
measure: Disease Control Rate (DCR)
timeFrame: 6th month
measure: Disease Control Rate (DCR)
timeFrame: 12th month
measure: Overall Survival
timeFrame: 3rd month
measure: Overall Survival
timeFrame: 6th month
measure: Overall Survival
timeFrame: 12th month
Secondary outcomes:
measure: Changes in Inflammatory Markers (ICC)
timeFrame: 3rd month
measure: Changes in Inflammatory Markers (ICC)
timeFrame: 6th month
measure: Changes in Inflammatory Markers (ICC)
timeFrame: 12th month
measure: Changes in Inflammatory Markers (MCVL)
timeFrame: 3rd month
measure: Changes in Inflammatory Markers (MCVL)
timeFrame: 6th month
measure: Changes in Inflammatory Markers (MCVL)
timeFrame: 12th month
measure: Immune-related adverse events (irAEs)
timeFrame: 3rd month
measure: Immune-related adverse events (irAEs)
timeFrame: 6th month
measure: Immune-related adverse events (irAEs)
timeFrame: 12th month
measure: Response Based on Metastatic Sites
timeFrame: 3rd month
measure: Response Based on Metastatic Sites
timeFrame: 6th month
measure: Response Based on Metastatic Sites
timeFrame: 12th month
measure: Evaluation of Neutrophil-Lymphocyte Ratio
timeFrame: 3rd month
measure: Evaluation of Neutrophil-Lymphocyte Ratio
timeFrame: 6th month
measure: Evaluation of Neutrophil-Lymphocyte Ratio
timeFrame: 12th month
measure: Evaluation of Platelet-Lymphocyte Ratio
timeFrame: 3rd month
measure: Evaluation of Platelet-Lymphocyte Ratio
timeFrame: 6th month
measure: Evaluation of Platelet-Lymphocyte Ratio
timeFrame: 12th month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Health Science University Kartal Dr. Lütfi Kirdar City Hospital
state: Kartal
Study officials:
affiliation: Health University Kartal Dr. Lütfi Kirdar City Hospital
name: Heves Surmeli, MD
role: PRINCIPAL_INVESTIGATOR
References: