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

¿Cuál es el Propósito de este estudio?

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.

¿Cuál es la Condición que se está estudiando?

Cáncer de vejiga

¿Quién puede participar en el Estudio?

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

¿Qué Implica?

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.