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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants are eligible to be included in the study only if all the following criteria apply.

∙ Type of Participant and Disease Characteristics

⁃ 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

⁃ Patients must have at least ONE available assessment of molecular residual disease by the Signatera® (Natera Inc.) assay performed within the last 90 days prior to enrollment in study.

⁃ Demographics

⁃ Be ≥18 years of age on the day of signing informed consent.

⁃ Female Participants:

⁃ Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

⁃ Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study drug.

⁃ Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.

⁃ Male Participants:

⁃ Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of trial therapy through 120 days after the last dose of study therapy.

⁃ Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.

⁃ Informed Consent

⁃ The participant provides written informed consent for the trial. The participant may also provide consent for Future Biomedical Research; however, the participant may participate in the main trial without participating in Future Biomedical Research.

⁃ Other Inclusion Criteria

⁃ Have intermediate-high risk, high risk RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status {Oza, 2022 #4431}

• Intermediate-high risk RCC

‣ pT2, Gr. 4 or sarcomatoid, N0, M0

⁃ pT3, Any Gr., N0, M0

∙ High risk RCC

‣ pT4, Any Gr. N0, M0

⁃ pT Any stage, Any Gr., N+, M0

⁃ Have received no prior systemic therapy for advanced RCC unless having recently initiated immunotherapy with pembrolizumab for no more than 6 weeks or 1 dose prior to enrollment.

‣ Have undergone a partial nephroprotective or radical complete nephrectomy)

‣ Must have undergone a nephrectomy ≥28 days prior to signing informed consent and ≤12 weeks prior to enrollment.

‣ Must be tumor free as assessed by the investigator and validated by either CT or MRI scan of the brain and CAP ≤28 days from randomization.

‣ Have an ECOG PS ≤2.

‣ Have adequate organ function

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Charles Peyton, MD
cpeyton@uabmc.edu
(205) 934-1984
Backup
Margaret A Thomas, MPH
margaretannthomas@uabmc.edu
(205) 895-1802
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2028-09
Participants
Target number of participants: 100
Treatments
No_intervention: Arm 1: MRD negative patients
Active_comparator: Arm 2 MRD positive patients
Patients are treated with Pembrolizumab 400 mg IV q 6 weeks for a total of 1 year
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov