drugset / Trial / NCT06005818

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

NCT06005818 ↗

Phase 2 Recruiting 100 enrolled University of Alabama at Birmingham
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-01-01
Primary completion
2027-07
Completion
2028-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pembrolizumab Monoclonal antibody 400 mg Intravenous

Indications