Alliance A032201 STRIKE (High Risk Renal Cell Carcinoma) - Clinical Trial

What is the Purpose of this Study?

The purpose of this study is to determine whether an experimental blood test (Signatera®) can help us make better decisions about who should get immunotherapy after surgery to remove the bladder for bladder cancer and which immunotherapy treatment will be the best choice.

What is the Condition Being Studied?

Cáncer de vejiga

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have histologically confirmed urothelial cancer of the bladder
  • Have had a radical cystectomy at least 3 weeks, but not more than 12 weeks, before joining the study
  • Have no evidence of residual cancer or metastases after surgery
  • Have never received previous treatment with any PD-1 or PD-L1 axis inhibitors

For more information, contact the study team at nick.jeffries@duke.edu.

Grupo etario
Adultos

What is Involved?

If you choose to join this study, you will get a blood draw and have the study test run. Based on the results of the study test, you will then get a group assignment.

  • Group A: You will be in this group if you have a "positive" first study test. People in this group will get a random assignment (by chance) to get either a single immunotherapy drug, called nivolumab, or a combination of two immunotherapy drugs, called nivolumab plus relatlimab. You will get the drug(s) through a vein in the arm once every 28 days. 28 days is called 1 cycle. You will receive up to 12 total cycles of immunotherapy treatment.
  • Group B: You will be in this group if you have a "negative" first study test. People in this group will get a random assignment to get an immunotherapy drug called nivolumab or be on close monitoring without receiving initial immunotherapy. If you are assigned to receive immediate treatment with nivolumab, you will get this drug \through a vein in the arm once every 28 days. 28 days is called 1 cycle. You will receive up to 12 cycles. If you are assigned to close monitoring without immediate immunotherapy, you will be told if your Signatera test changes from negative to positive and then offered treatment with nivolumab at that time for up to 12 cycles if you have a later positive result.

Study Details

Full Title
A032201: Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-risk renal cell carcinoma - STRIKE
Principal Investigator
Especialista en oncología médica
Protocol Number
IRB: PRO00118061
NCT: NCT06661720
Phase
Phase III
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción