Testing the Investigational Medication Pembrolizumab After Kidney Removal for Patients With Non-Clear Cell Renal Cell Carcinoma

Starting soon · Phase 3

Conditions studied: Non-Clear Cell Renal Cell Carcinoma, Stage III Renal Cell Cancer AJCC v8, Stage IV Renal Cell Cancer AJCC v8

In brief

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.

Key facts

Study ID: NCT07689240
Run by: National Cancer Institute (NCI)
People needed: 400
Starts: 2027-02-10
Expected to finish: 2032-01-01
Last updated by the study team: 2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 within 2 years prior to randomization
Patient must not have active known or suspected autoimmune disease requiring systemic immunosuppression. The following autoimmune disorders are permitted: patients with vitiligo, type I diabetes mellitus, controlled/stable hypo or hyperthyroidism due to autoimmune or non-autoimmune conditions (hormone replacement is allowed), psoriasis not requiring systemic treatment
Patient must not be on any immunosuppressant therapy other than inhaled steroids, intranasal steroids, topical steroids, injection steroids and systemic steroids up to 10mg prednisone equivalent
Patient must have recovered adequately from toxicity and/or complications related to any surgery received prior to randomization
Patient must not have a history or current evidence of uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase the risk of incurring adverse events (AEs), or compromise the ability of the patient to give written informed consent
Patient must not have had a history of allogeneic organ transplantation
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used
All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy
A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Patients of childbearing potential assigned to Arm B must continue contraception requirements for 4 months following the last dose of pembrolizumab. Patients assigned to Arm B must also not breastfeed while on protocol treatment and for 4 months after the last dose of pembrolizumab
Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible
Leukocytes ≥ 3,000/ mm\^3 (must be obtained ≤ 42 days prior to protocol randomization)
Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 (must be obtained ≤ 42 days prior to protocol randomization)
Platelets ≥ 100,000/ mm\^3 (must be obtained ≤ 42 days prior to protocol randomization)

Full record on ClinicalTrials.gov

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