Study on Using Molecular Residual Disease to Guide Additional Therapy in Kidney Cancer
Sponsor: University of Alabama at Birmingham
ClinicalTrials ID:NCT06005818
This clinical trial is exploring whether using molecular residual disease (MRD) can help guide additional treatment decisions for patients with clear cell renal cell carcinoma (RCC) after surgery. The study aims to see if this approach can improve survival outcomes for high-risk patients.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to determine if using molecular residual disease (MRD) information can help guide treatment decisions for patients with clear cell renal cell carcinoma (RCC) after surgery. The study will look at how long patients remain free of cancer progression and their overall survival when treatment is based on MRD results. Patients without detectable MRD will skip additional therapy with pembrolizumab, while those with MRD will continue with this standard treatment.
Description
This study involves patients with localized kidney cancer who are eligible for standard treatment with pembrolizumab. It aims to see if patients can safely skip this treatment if they show no signs of molecular residual disease (MRD) after surgery.
The main goals are to estimate how long patients remain free of cancer and their overall survival when treatment is guided by MRD results. The study will also assess the safety of this approach.
About 100 adult patients with non-metastatic clear cell renal cell carcinoma will participate. They must have had surgery to remove the tumor and will be monitored for cancer progression and survival. The trial will take place at various centers in the United States.
Eligibility Criteria
Inclusion Criteria
- Must have a confirmed diagnosis of clear cell renal cell carcinoma, with or without certain features.
- Must have had an MRD assessment using the Signatera® test within 90 days before joining the study.
- Must be 18 years or older.
- Female participants of childbearing potential must have a negative pregnancy test before starting the study and agree to use contraception during the study and for 120 days after the last dose.
- Male participants must agree to use contraception during the study and for 120 days after the last dose.
- Must provide written informed consent to participate.
- Must have intermediate-high or high-risk RCC based on specific medical criteria.
- Must not have received prior systemic therapy for advanced RCC, except for a limited amount of pembrolizumab.
- Must have had a nephrectomy (kidney removal surgery) at least 28 days before joining the study and no more than 12 weeks before.
- Must be tumor-free as confirmed by a CT or MRI scan.
- Must have a performance status score of 2 or less, indicating good overall health.
- Must have adequate organ function.
Exclusion Criteria
- Have an immune system deficiency or are on long-term steroid therapy or other immunosuppressive treatments.
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have another progressing cancer or one that required treatment in the past 3 years, with some exceptions.
- Have an active infection needing treatment.
- Have a history of or are currently on dialysis.
- Have a known HIV infection or active hepatitis B or C.
- Have active tuberculosis.
- Have any condition or treatment that could interfere with the study results or participation.
- Have a psychiatric or substance abuse disorder affecting study participation.
- Have had a solid organ transplant.
- Have a severe allergy to pembrolizumab or its components.
- Are pregnant, breastfeeding, or planning to conceive during the study.
- Have received prior cancer therapy and not recovered from side effects.
- Have received a live vaccine within 30 days before starting the study.
- Are participating in another clinical trial or have used an investigational device recently.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.