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NCT06005818Not yet recruiting

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

University of Alabama at BirminghamPhase 2ClinicalTrials.govdrug
Study focus
Disease/Condition
Renal Cell Carcinoma
Drug/Device/Intervention
Pembrolizumab injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
University of Alabama at Birmingham
Location
Birmingham, United States of America
Timeline & enrollment
Phase
Phase 2
Start date
Dec 01, 2023
End date
Jun 30, 2025
Enrollment
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 pelvisMalignant neoplasm of renal pelvisSecondary malignant neoplasm of kidney and renal pelvisBenign neoplasm: KidneyBenign neoplasm: Renal pelvis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06005818
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.