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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Bone Scan
  • Computed Tomography
  • Echocardiography Test
  • Magnetic Resonance Imaging
  • Patient Observation
  • Pembrolizumab
  • Positron Emission Tomography

Treatment groups

400 Participants
are divided into 2 treatment groups

Locations

This trial has no locations