RecruitingPhase 2NCT06005818

Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)


Sponsor

University of Alabama at Birmingham

Enrollment

100 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this Clinical Study is to understand the outcomes by informing therapy choice for adjuvant treatment in clear cell renal cell carcinoma by using molecular residual disease. The main question\[s\] it aims to answer are: * what is the progression free survival of a cohort of high risk resected RCC patients when treated based on MRD * what is the overall survival of high risk resected RCC patients when treated based on MRD Participants will forgo adjuvant therapy with pembrolizumab if they have no detectable molecular residual disease. Participants will continue on with standard of care pembrolizumab if they do appear to have molecular residual disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a blood test that detects tiny fragments of tumor DNA (called molecular residual disease, or MRD) to decide whether patients with high-risk kidney cancer (renal cell carcinoma) who had surgery should receive follow-up immunotherapy treatment. **You may be eligible if:** - You are 18 or older - You have high-risk or intermediate-high-risk kidney cancer (clear cell type) - You recently had your kidney (partially or fully) removed - You have had an MRD blood test (Signatera) within the past 90 days - You have not received prior systemic therapy for kidney cancer (or only just started pembrolizumab) **You may NOT be eligible if:** - You are on immune-suppressing medications or have an autoimmune disease requiring treatment - You have had an organ transplant - You have HIV, active hepatitis B/C, or active tuberculosis - You are pregnant or breastfeeding - You received a live vaccine in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPembrolizumab injection

PD-1 antibody


Locations(1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06005818


Related Trials