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

Sponsor
National Cancer Institute (NCI)
Study ID
NCT07689240
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Non-Clear Cell Renal Cell Carcinoma
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • Computed Tomography — PROCEDURE
    Undergo CT and PET/CT
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Patient Observation — OTHER
    Undergo active surveillance
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT

Study Details

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 Dates

First listed
Jul 8, 2026
Start date
Feb 10, 2027
Status verified
Jul 2026
Primary completion
Jan 1, 2032
Completion
Jan 1, 2032

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (active surveillance)
    Patients undergo active surveillance, including CT or MRI, every 3 months for 1 year. Patients also undergo collection of blood samples on study and CT or MRI during follow up. Patients may undergo ECHO and/or bone scan and/or PET/CT if clinically indicated.
  • Experimental: Arm B (pembrolizumab)
    Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for up to 9 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI throughout the trial and collection of blood samples on study. Patients may undergo ECHO and/or bone scan and/or PET/CT if clinically indicated.

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: 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 ]

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