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

NCT06607809 | Completed

• 1 other identifier: 2024/010.99/6/9
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Renal Cell Carcinoma

Keywords

RCC; Nivolumab; inflammatory marker; ICC; MCVL

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (18)

• Changes in Inflammatory Markers (ICC)

  3rd month

• Changes in Inflammatory Markers (ICC)

  6th month

• Changes in Inflammatory Markers (ICC)

  12th month

• Changes in Inflammatory Markers (MCVL)

  3rd month

• Changes in Inflammatory Markers (MCVL)

  6th month

Eligibility Criteria

• Age: 19 Years - 87 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.
• Immunodeficiency or Immunosuppressive Therapy: Patients with immunodeficiency or those receiving immunosuppressive therapy (e.g., corticosteroids) were excluded from the study.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Health Science University Kartal Dr. Lütfi Kirdar City Hospital

Istanbul, Kartal, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Heves Surmeli, MD

  Health University Kartal Dr. Lütfi Kirdar City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: February 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

TU (1)