← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year from surgery

Awards & highlights

MRD GATE RCC Trial 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.Check my eligibility

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.See study design

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.

MRD GATE RCC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My kidney cancer is considered high risk based on its size, spread, and grade.

Select...

I have had surgery to remove part or all of my kidney.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I am 18 years old or older.

Select...

My kidney cancer has been confirmed by a lab test and has clear cell features.

MRD GATE RCC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year from surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year from surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year from surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Disease Free Survival (DFS) by Investigator's assessment as defined by RECIST 1.1

Secondary outcome measures

Overall Survival (OS)

MRD GATE RCC Trial Design

2Treatment groups

Active Control

Group I: Arm 1: MRD negative patientsActive Control1 Intervention

Group II: Arm 2 MRD positive patientsActive Control1 Intervention

Patients are treated with Pembrolizumab 400 mg IV q 6 weeks for a total of 1 year

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,562 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the FDA sanctioning Arm 2 MRD positive patients' treatments?

"With a score of 2, our internal team at Power considers Arm 2 MRD positive patients to be moderately safe. Although there is evidence indicating safety in this Phase 2 trial, efficacy has yet to be established."

Answered by AI

Does this medical trial still offer its services to participants?

"Accessing information from clinicaltrials.gov, it appears that this research investigation is not presently open for recruitment. Initially posted on December 1st 2023 and recently updated September 21st 2023, the trial has yet to amass a sufficient amount of test subjects. Nevertheless, there are 2,681 other studies actively seeking participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Arnab Basu 2023. "Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005818.