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Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC) - Trial NCT06005818

Access comprehensive clinical trial information for NCT06005818 through Pure Global AI's free database. This Phase 2 trial is sponsored by University of Alabama at Birmingham and is currently Not yet recruiting. The study focuses on Renal Cell Carcinoma. Target enrollment is 100 participants.

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NCT06005818
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06005818
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Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)

Study Focus

Renal Cell Carcinoma

Pembrolizumab injection

Interventional

drug

Sponsor & Location

University of Alabama at Birmingham

Birmingham, United States of America

Timeline & Enrollment

Phase 2

Dec 01, 2023

Jun 30, 2025

100 participants

Primary Outcome

Disease Free Survival (DFS) by Investigator's assessment as defined by RECIST 1.1

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.

ICD-10 Classifications

Malignant neoplasm of kidney, except renal pelvis
Malignant neoplasm of renal pelvis
Secondary malignant neoplasm of kidney and renal pelvis
Benign neoplasm: Kidney
Benign neoplasm: Renal pelvis

Data Source

ClinicalTrials.gov

NCT06005818

Non-Device Trial