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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06005818
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab injection — DRUG
    PD-1 antibody

Study Details

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.

Key Dates

Start date
Jan 1, 2024
Status verified
Oct 2025
Primary completion
Jul 31, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Disease Free Survival (DFS) by Investigator's assessment as defined by RECIST 1.1 [ Time Frame: 1 year from surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Charles Peyton, MD
[email protected]
(205) 934-1984

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By specialty
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By research site
University of Alabama at Birmingham· Birmingham, AL

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