Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)
University of Alabama at Birmingham
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.
Description
This is a multicenter open label biomarker integral treatment de-escalation study, where patients with localized renal cell carcinoma who are otherwise eligible to receive standard of care pembrolizumab will be offered observation only, if they do not demonstrate presence of molecular residual disease. Primary Objective(s): Provide an estimate for the 1 year -Disease-Free Survival (DFS) Provide an estimate for overall Survival (OS) for patients treated based on MRD information. Estimate the safety of an MRD based strategy of adjuvant therapy in RCC Primary Endpoint(s) : i. Disease Free Su…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants are eligible to be included in the study only if all the following criteria apply. Type of Participant and Disease Characteristics 1. Must have histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features. Diagnosis of RCC with clear cell component is to be made by the investigator and does not require central histology review. Molecular Residual Disease 2. Patients must have at least ONE available assessment of molecular residual disease by the Signatera® (Natera Inc.) assay performed within the last 90 days…
Interventions
- DrugPembrolizumab injection
PD-1 antibody
Location
- University of Alabama at BirminghamBirmingham, Alabama