A Phase II Study of Bintrafusp Alfa (M7824) in Checkpoint Inhibitor Naive and Refractory Subjects With Urothelial Carcinoma
Status:
Suspended
Trial end date:
2021-12-19
Target enrollment:
Participant gender:
Summary
Background:
Metastatic urothelial carcinoma is lethal and has no cure. Response rates to current
treatments are modest. Researchers want to find new strategies to treat the disease. In this
study, they will test a drug called M7824. The drug is a new immunotherapy that blocks the
pathways that cancer cells use to stop the immune system from fighting cancer.
Objective:
To learn if M7824 can help the immune system s ability to fight urothelial cancer.
Eligibility:
People age 18 and older who have urothelial cancer that has spread to other parts of their
body and they have been previously treated with chemotherapy or immunotherapy
Design:
Participants will be screened with a medical history and physical exam. They will have blood
and urine tests. They will have imaging scans. They will have an electrocardiogram to measure
heart function. Their ability to perform their normal activities will be evaluated. They may
have a tumor biopsy. They will take a pregnancy test if needed.
Participants will repeat some of the screening tests during the study.
Treatment will be given in a series of 28-day cycles. Participants will get M7824 once every
2 weeks. It is given through an intravenous infusion. For this, a small plastic tube is put
into an arm vein. They will get M7824 until their disease gets worse, they have unacceptable
side effects, or they decide to stop treatment.
Participants will have a follow-up visit 30 days after treatment ends. Then they will be
followed every 12 weeks in the clinic or by telephone/email. Follow-up will last
indefinitely.