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Pembrolizumab for Kidney Cancer (MRD GATE RCC Trial)

Phase 2
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have intermediate-high risk, high risk RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status
Have undergone a partial nephroprotective or radical complete nephrectomy
Must not have
Has a known additional malignancy that is progressing or required active treatment ≤3 years ago
Has a history of, or is currently on, dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how well adjuvant therapy works for kidney cancer patients based on molecular residual disease.

Who is the study for?
Adults over 18 who've had kidney cancer surgery within the last 12 weeks, are tumor-free, and have certain high-risk factors. They must not be pregnant or breastfeeding, agree to use contraception, and have no history of severe immune conditions or recent live vaccines. Participants with detectable molecular residual disease will receive pembrolizumab; those without won't.
What is being tested?
The study tests if using molecular residual disease (MRD) to guide the use of pembrolizumab improves progression-free and overall survival in high-risk kidney cancer patients after surgery. Those with MRD get pembrolizumab; those without do not.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, infusion reactions, fatigue, skin rash, digestive issues like diarrhea or liver problems, hormonal gland changes causing hormone imbalances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney cancer is considered high risk based on its size, spread, and grade.
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I have had surgery to remove part or all of my kidney.
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I can take care of myself but might not be able to do heavy physical work.
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I am 18 years old or older.
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My kidney cancer has been confirmed by a lab test and has clear cell features.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another cancer that is growing or was treated within the last 3 years.
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I am currently on or have a history of dialysis.
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I have been treated for an autoimmune disease in the last 2 years.
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I have an active tuberculosis infection.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I am currently being treated for an infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Arm 2 MRD positive patientsActive Control1 Intervention
Patients are treated with Pembrolizumab 400 mg IV q 6 weeks for a total of 1 year
Group II: Arm 1: MRD negative patientsActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,284 Total Patients Enrolled
~8 spots leftby Dec 2024
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