Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma (NCT04417660) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Bintrafusp Alfa (M7824) in Subjects With Thymoma and Thymic Carcinoma
United States9 participantsStarted 2020-12-26
Plain-language 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.
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* IINCLUSION CRITERIA:
* 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/mm\^3 OR \>= 1.5 x 10\^9/L
* platelets: \>=\> 100,000/mm\^3 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 m\^2 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 su…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate
Timeframe: from the start of the treatment until disease progression/recurrence