Testing the Investigational Medication Pembrolizumab After Kidney Removal for Patients With Non-C… (NCT07689240) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Testing the Investigational Medication Pembrolizumab After Kidney Removal for Patients With Non-Clear Cell Renal Cell Carcinoma
400 participantsStarted 2027-02-10
Plain-language summary
This phase III trial compares the effect of pembrolizumab to active surveillance after a surgical procedure to completely or partially remove a kidney (nephrectomy) in improving time without disease in patients with non-clear cell renal cell cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after nephrectomy may be more effective than the usual active surveillance approach for improving time without disease in patients with non-clear cell renal cell cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient must be ≥ 18 years of age
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patient must have histologically confirmed non-clear cell renal cell carcinoma (nccRCC) with ≥ pT3Nx or pTanyN+ or pTanyNanyM1 with no evidence of disease (NED) per the American Joint Committee on Cancer (AJCC) 8th edition
* Patient must not have renal medullary carcinoma
* Patient must have had a partial or radical nephrectomy. In the case of patients with M1 NED status, a complete resection of the metastatic lesion(s) (metastasectomy) must have been completed at the time of nephrectomy or within 1 year after nephrectomy
* Positive margins are allowed as long as no gross disease
* Patient must not have residual thrombus post nephrectomy in the vena renalis or vena cava
* Patient must be randomized ≤ 16 weeks after nephrectomy and/or \< 16 weeks after metastasectomy
* Patient must have undergone imaging of chest, abdomen and pelvis with a CT or MRI after nephrectomy/metastasectomy and within 42 days prior to randomization documenting there is no evidence of liver, bone, or brain metastases
* Patient must not have received any prior anti-PD-1/PD-L1 or CTLA-4 agents
* Patient must not have received any prior radiotherapy for nccRCC
* Patient must not have received prior systemic treatment for nccRCC (except nephrectomy or metastasectomy). Patient must not have received prior immune checkpoint inhibitor agents for other cancers …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease-free survival (DFS)
Timeframe: From randomization to first documented local recurrence, distant metastasis, secondary systemic malignancy, or death due to any cause, whichever occurs first, assessed up to 10 years