Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04417660|
Recruitment Status : Recruiting
First Posted : June 5, 2020
Last Update Posted : December 30, 2020
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.
To see if bintrafusp alfa (M7824) is an effective treatment for thymoma and thymic carcinoma.
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
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:
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Thymic Epithelial Tumor Recurrent Thymoma Thymic Cancer||Drug: M7824||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II, Open-Label Trial of Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma|
|Actual Study Start Date :||December 26, 2020|
|Estimated Primary Completion Date :||January 1, 2023|
|Estimated Study Completion Date :||January 1, 2024|
Experimental: Bintrafusp alfa (M7824)
Bintrafusp alfa will be administered at a dose of 1200 mg intravenously once every two weeks until diseaseprogression or development of intolerable adverse events.
Bintrafusp alfa will be administered at a dose of 1200 mg intravenously once every two weeks until disease progression or development of intolerable adverse events.
- Overall response rate [ Time Frame: From the start of the treatment until disease progression/recurrence ]Overall response rate for M7824 based on RECIST criteria
- Duration of response, progression free survival & overall survival [ Time Frame: from the start of the treatment until disease progression/recurrence ]To determine duration of response, progression free survival and overall survival in patients with recurrent thymic epithelial TETs
- Safety & tolerability of M7824 [ Time Frame: from the start of the treatment until disease progression/recurrence ]To determine the safety and tolerability of 1200 mg M7824 administered once every 2 weeks in patients with thymoma and thymic carcinoma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04417660
|Contact: Shannon G Swift, R.N.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Arun Rajan, M.D.||National Cancer Institute (NCI)|