Renal Cell CarcinomaPhase 2MRD GATE RCCNCT06005818
Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)
A Phase 2 study testing Pembrolizumab injection in people with Renal Cell Carcinoma, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Pembrolizumab injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 30Show fewer
- 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
Who cannot join
- 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.
Show all 20Show fewer
- 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.
- Prior/Concomitant Therapy
- Has received prior anticancer therapy and not recovered from AEs due to previously administered agents. Note: denosumab may be allowed for bone protective purposes if dosing has been stable for ≥2 weeks before screening.
- Has received a live vaccine within 30 days prior to the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.
- Prior/Concurrent Clinical Study Experience
- Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Charles Peyton, MD, (205) 934-1984 ext. 205-996-4315, cpeyton@uabmc.edu
About this study
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.
Read the detailed description
This is a multicenter open label biomarker integral treatment de-escalation study, where patients with localized renal cell carcinoma who are otherwise eligible to receive standard of care pembrolizumab will be offered observation only, if they do not demonstrate presence of molecular residual disease.
Primary Objective(s):
Provide an estimate for the 1 year -Disease-Free Survival (DFS) Provide an estimate for overall Survival (OS) for patients treated based on MRD information.
Estimate the safety of an MRD based strategy of adjuvant therapy in RCC
Primary Endpoint(s) :
- Disease Free Survival (DFS) by Investigator's assessment as defined by RECIST 1.1
Secondary Endpoint:
- Overall Survival at 1 year from surgery ii. Safety as defined by incidence of adverse events per NCI CTCAE v5.0
100 patients with non-metastatic clear cell renal cell carcinoma who undergo surgery to remove tumor will be enrolled, patients will be adults (≥18 years), there are no gender, age, demographic group related constraints, the trial will be conducted at centers based in the United States.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Pembrolizumab injection
- Keywords
- ADJUVANT
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab injectionDrug
PD-1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: MRD negative patients | No intervention | Not described |
| Arm 2 MRD positive patients | Active comparator | Patients are treated with Pembrolizumab 400 mg IV q 6 weeks for a total of 1 year Receives: Drug: Pembrolizumab injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS) by Investigator's assessment as defined by RECIST 1.1
Measured: 1 year from surgery
Secondary outcomes (1)
Overall Survival (OS)
Measured: 1 year from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Jan 2024
- Primary completionJul 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Peyton, University of Alabama at Birmingham
- Investigators
- Charles A Peyton, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005818
- Sponsor's protocol ID
- UAB2369
- Acronym
- MRD GATE RCC
- Status last verified
- Oct 2025
- First submitted
- 14 Aug 2023
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Residual Disease (MRD) Guided Adjuvant ThErapy in Renal Cell Carcinoma (RCC)
- ClinicalTrials.gov ID
- NCT06005818
- Acronym / sponsor ID
- MRD GATE RCC / UAB2369
- Conditions
- Renal Cell Carcinoma
- Keywords
- ADJUVANT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter open label biomarker integral treatment de-escalation study, where patients with localized renal cell carcinoma who are otherwise eligible to receive standard of care pembrolizumab will be offered observation only, if they do not demonstrate presence of molecular residual disease.
Primary Objective(s):
Provide an estimate for the 1 year -Disease-Free Survival (DFS) Provide an estimate for overall Survival (OS) for patients treated based on MRD information.
Estimate the safety of an MRD based strategy of adjuvant therapy in RCC
Primary Endpoint(s) :
- Disease Free Survival (DFS) by Investigator's assessment as defined by RECIST 1.1
Secondary Endpoint:
- Overall Survival at 1 year from surgery ii. Safety as defined by incidence of adverse events per NCI CTCAE v5.0
100 patients with non-metastatic clear cell renal cell carcinoma who undergo surgery to remove tumor will be enrolled, patients will be adults (≥18 years), there are no gender, age, demographic group related constraints, the trial will be conducted at centers based in the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: MRD negative patients | No intervention | – |
| Arm 2 MRD positive patients | Active comparator | Drug: Pembrolizumab injectionPatients are treated with Pembrolizumab 400 mg IV q 6 weeks for a total of 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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.
Key exclusion criteria (20 listed)
- Medical Conditions
- Prior/Concomitant Therapy
- Prior/Concurrent Clinical Study Experience
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab injectionPD-1 antibody | Drug | Arm 2 MRD positive patients |
Primary outcome
Disease Free Survival (DFS) by Investigator's assessment as defined by RECIST 1.1
Time frame: 1 year from surgery
1 secondary outcome
Overall Survival (OS)
Time frame: 1 year from surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Renal Cell Carcinoma
RecruitingPhase 3
Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
Metastatic Clear Cell Renal Cell Carcinoma, Advanced Clear Cell Renal Cell Carcinoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Not yet recruitingPhase 2
Neoadjuvant Belzutifan Plus Pembrolizumab in High-Risk, Locally Advanced Clear Cell Renal Cell Carcinoma
Locally Advanced Clear Cell Renal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Charles A Peyton, MD principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab injection in people with Renal Cell Carcinoma, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles Peyton, MD ((205) 934-1984, cpeyton@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) by Investigator's assessment as defined by RECIST 1.1 (time frame: 1 year from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.