A Phase II, Open-Label Trial of Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
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.
• Participants must have histologically confirmed (by the pathology department/CCR/NCI) thymoma or thymic carcinoma.
• Participants must have had at least one prior line of platinum-based chemotherapy. Progressive disease must be documented prior to study entry and participants must have advanced, unresectable disease that is not amenable to surgical resection.
• Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST1.1.
• Participants must be aged \>=18 years.
• ECOG performance status \<=1.
• Participants must have adequate organ and marrow function as defined below:
‣ absolute neutrophil count: \>= 1,500/mm3 OR \>= 1.5 x 10(9)/L
⁃ platelets: \>=\> 100,000/mm3 OR \>= 100 x 10(9)/L
⁃ hemoglobin: \>= 9g/dL (may have been transfused)
⁃ total bilirubin: \<= the upper limit of normal range (ULN) OR \<= 3.0 x ULN for participants with documented metastatic disease to the liver
⁃ AST(SGOT)/ALT(SGPT): \<= 1.5 x ULN OR \<= 5 x ULN for participants with documented metastatic disease to the liver
⁃ ALP: \<= 2.5 x ULN
⁃ creatinine clearance: \>= 60 mL/min/1.73 m2 calculated by calculated using eGRF in the clinical lab
⁃ INR: normal INR, per institutional guidelines
⁃ PT: \<= 1.5 x ULN
⁃ aPTT: \<= 1.5 x ULN
• Negative serum or urine pregnancy test at screening for individuals of childbearing potential (IOCBP). NOTE: IOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal. If necessary, to confirm postmenopausal status an FSH level will be included at screening. The effects of Bintrafusp alfa on the developing human fetus are unknown. For this reason, individuals of childbearing potential and those that can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for at least 2 months after the last dose of the drug.
• Participants with previously treated brain or CNS metastases are eligible provided that the participant has recovered from any acute side effects of radiotherapy and does not require treatment with steroids, and any whole brain radiation therapy was completed at least 2 weeks prior to enrollment.
• Ability of participant to understand and the willingness to sign a written informed consent document.