Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)
NCT06005818 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2025-10-21
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.
Conditions
Interventions
- DRUG
-
Pembrolizumab injection
PD-1 antibody
Sponsors & Collaborators
-
University of Alabama at Birmingham
lead OTHER
Principal Investigators
-
Charles A Peyton, MD · The University of Alabama at Birmingham
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-01-01
- Primary Completion
- 2027-07-31
- Completion
- 2028-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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