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NCT04417660 · ClinicalTrials.gov record · last posted 2026-08-11

Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma

StatusActive, Not Recruiting
PhasePhase 2
Started2020-12-26
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from the ClinicalTrials.gov record
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. 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.

Protocol amendment history 2 changes detected by DataLookout

2026-08-12
notable
Primary completion pushed: 2026-07-31 → 2026-12-31
2026-08-12
minor
Completion pushed: 2026-12-31 → 2027-07-01
Trial Details
NCT Number NCT04417660
Lead Sponsor National Cancer Institute (NCI)
Conditions Thymic Epithelial Tumor, Recurrent Thymoma, Thymic Cancer
Enrollment 9 participants
Start Date 2020-12-26
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-11