Actively Recruiting
Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)
Led by University of Alabama at Birmingham · Updated on 2025-10-21
100
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features
- At least one molecular residual disease assessment by Signatera assay performed within 90 days prior to enrollment
- Age 18 years or older at the time of informed consent
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours prior to randomization and agree to use contraception through 120 days after last study drug dose
- Male participants of childbearing potential must agree to use contraception from first dose through 120 days after last study drug dose
- Written informed consent provided
- Intermediate-high or high risk RCC defined by specific pathological tumor-node-metastasis and Fuhrman grading criteria
- No prior systemic therapy for advanced RCC except limited recent pembrolizumab use (no more than 6 weeks or 1 dose prior to enrollment)
- Underwent partial or radical nephrectomy 8 to 84 days prior to informed consent and 12 weeks prior to enrollment
- Tumor-free as assessed by investigator, confirmed by CT or MRI within 28 days from randomization
- ECOG performance status 0 to 2
- Adequate organ function
You will not qualify if you...
- Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (>10 mg prednisone daily) or other immunosuppressive therapy within 7 days before first study dose
- Active autoimmune disease requiring systemic treatment in past 2 years (replacement therapy allowed)
- Known additional malignancy progressing or requiring treatment within past 3 years, except certain early-stage cancers treated with curative intent
- Active infection requiring systemic therapy
- History of or current dialysis
- Known HIV infection
- Active hepatitis B or hepatitis C infection
- Active tuberculosis
- Any condition, therapy, or abnormality interfering with trial participation or results
- Known psychiatric or substance abuse disorder interfering with trial cooperation
- Prior solid organ transplant
- Severe hypersensitivity (grade 3 or higher) to pembrolizumab or its excipients
- Positive pregnancy test within 72 hours before randomization in women of childbearing potential
- Pregnant, breastfeeding, or planning to conceive/father children during study and 120 days after last dose
- Unrecovered adverse events from prior anticancer therapy (denosumab allowed if stable)
- Live vaccine received within 30 days before first study treatment
- Participation in another investigational trial or device use within 4 weeks before first study treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
C
Charles Peyton, MD
CONTACT
M
Margaret A Thomas, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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