Alliance A032201 STRIKE (High Risk Renal Cell Carcinoma)

Alliance A032201 STRIKE (High Risk Renal Cell Carcinoma)

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Purpose of this Study

This study has two groups based on a test called the Signatera test. People in Group A have a positive test. They will be placed by chance into one of two treatment groups. One group will get a medicine called nivolumab. The other group will get two medicines, nivolumab and relatlimab. These medicines are given through a vein once every 28 days, and people can get up to 12 cycles. People in Group B have a negative test. They will be placed by chance into one of two choices. One choice is to get nivolumab right away, given through a vein once every 28 days for up to 12 cycles. The other choice is close monitoring without starting medicine right away. If their Signatera test changes from negative to positive, they will then be offered nivolumab for up to 12 cycles.

Who Can Participate?

Eligibility

This study is for adults who had bladder cancer and had their bladder removed with surgery. To join, a person must have bladder cancer confirmed by a microscope. Their surgery must have been at least three weeks ago but not more than twelve weeks ago when they first join. They must have no signs of cancer left in their body, and their scans must show no spread of the disease. Tumor samples from the surgery must be available for a special blood test called the Signatera test. People cannot join if they have autoimmune diseases, lung inflammation, heart inflammation, active hepatitis B or C, or if they have had certain cancer treatments before. They must be at least 18 years old, not pregnant, and able to take care of themselves. Some people may join later if a blood test shows that cancer DNA appears in their blood after surgery. They must still have no signs of cancer on their scans, and their health must be safe for treatment with the study drug nivolumab.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

The purpose of this study is to find out if a blood test can help doctors make better choices about who should get immunotherapy after bladder cancer surgery. The study also wants to learn which immunotherapy treatment works best for people after their bladder is removed.

Locations

Duke University Hospital
Duke Raleigh Hospital

Visit Timing

Weekdays

Compensation

No

Spanish Materials Available

Yes

Study Details

Full Title

A032201: Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-risk renal cell carcinoma (STRIKE)

Principal Investigator

Daniel
George

Protocol Number

PRO00118061

NCT ID

NCT06661720

Phase

III

Enrollment Status

Open to Enrollment