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

NCT06005818 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UAB2369
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Cell Carcinoma

Keywords

ADJUVANT

Outcome Measures

Primary Outcomes (1)

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

  1 year from surgery

Secondary Outcomes (1)

• Overall Survival (OS)

  1 year from surgery

Study Arms (2)

Arm 1: MRD negative patients

NO INTERVENTION

Arm 2 MRD positive patients

ACTIVE COMPARATOR

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

Drug: Pembrolizumab injection

Interventions

Pembrolizumab injection DRUG

PD-1 antibody

Arm 2 MRD positive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medical Conditions
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment.
• Has an active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Has a known additional malignancy that is progressing or required active treatment ≤3 years ago. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy.
• Has an active infection requiring systemic therapy.
• Has a history of, or is currently on, dialysis.
• Has a known history of human immunodeficiency virus infection. No human immunodeficiency virus testing is required unless mandated by local health authority.
• Has a known active hepatitis B (hepatitis B surface antigen reactive) or HCV (eg, HCV RNA \[qualitative\] is detected).
• Has a known history of active tuberculosis (Bacillus tuberculosis).
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
• Has a known psychiatric or substance abuse disorder that would interfere with the cooperation with the requirements of the trial in the opinion of the investigator.
• Has had a prior solid organ transplant.
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients (refer to Investigator's Brochure for further details on excipients).
• A Woman of Childbearing Potential (WOCBP) who has a positive urine pregnancy test within 72 hours before randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Participants must be excluded/discontinued from the trial in the event of a positive or borderline positive test result.
• Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 120 days after the last dose of study treatment.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Charles A Peyton, MD

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Peyton, MD

CONTACT

(205) 934-1984; cpeyton@uabmc.edu

Margaret A Thomas, MPH

CONTACT

(205) 895-1802; margaretannthomas@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 23, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 21, 2025

Record last verified: 2025-10

Locations

US (1)