Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
Status:
Suspended
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
Background:
Thymoma and thymic carcinoma are diseases of the thymus. Platinum-based chemotherapy is the
standard treatment for these diseases. But in many cases, the disease returns after
treatment. Researchers want to see if a new drug can help.
Objective:
To see if bintrafusp alfa (M7824) is an effective treatment for thymoma and thymic carcinoma.
Eligibility:
People age 18 and older who have thymoma or thymic cancer and their disease returned or
progressed after treatment with at least one platinum-containing chemotherapy treatment plan,
or they have refused standard therapy
Design:
Participants will be screened under a separate protocol. Their medical, medicine, and
treatment history will be reviewed. They will have a tumor biopsy if they do not have a
sample.
Participants will get the study drug once every 2 weeks as an intravenous infusion. For this,
a small plastic tube is put into an arm vein.
During the study, participants will undergo the following:
Medicine review
Physical exam
Review of their symptoms and their ability to perform their normal activities
Blood and urine tests
Thigh muscle scan (using MRI)
Tumor assessment (using MRI or CT)
Heart and lung function tests
Thyroid gland test
Skin assessment.
Participants may have tumor biopsies. Some of their blood and biopsy samples will be used for
gene testing.
Participants may take the study drug until their disease worsens or they cannot tolerate
treatment.
Participants will have follow-up visits 2 and 6 weeks after stopping treatment. Then they
will have long-term follow-up visits every 3 months. These may include imaging scans. Visits
may be done by phone, with scans (if needed) done at their doctor s office.