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

NCT04417660 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-04-07

No results posted yet for this study

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.

Conditions

  • Thymic Epithelial Tumor
  • Recurrent Thymoma
  • Thymic Cancer

Interventions

DRUG

M7824

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Arun Rajan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-26
Primary Completion
2026-07-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04417660 on ClinicalTrials.gov