Study on Bintrafusp Alfa (M7824) for Patients with Thymoma and Thymic Carcinoma

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04417660

Provider View

This clinical trial is testing a new drug, bintrafusp alfa (M7824), to see if it can help treat thymoma and thymic carcinoma, especially in cases where the disease has returned or worsened after standard chemotherapy.

Patient Parameters

Program Overview

Thymoma and thymic carcinoma are conditions affecting the thymus gland. The usual treatment involves chemotherapy with platinum-based drugs, but these cancers often come back after treatment. This study aims to find out if a new drug, bintrafusp alfa (M7824), can be an effective treatment for these cancers. Participants will receive the drug every two weeks through an IV infusion. The study will include regular check-ups, tests, and scans to monitor the participants' health and the drug's effects. Participants can continue the treatment until their cancer worsens or they experience side effects they cannot tolerate.

Description

This study is exploring a new treatment option for thymoma and thymic carcinoma, which are cancers of the thymus gland. The standard treatment for these cancers is chemotherapy with platinum-based drugs, but many patients see their cancer return or worsen after this treatment. Bintrafusp alfa (M7824) is a new drug being tested to see if it can help these patients.

Participants in the study will receive bintrafusp alfa through an IV infusion every two weeks. The study will involve regular medical check-ups, including physical exams, blood and urine tests, scans of the tumor, and assessments of heart, lung, and thyroid function. Some participants may also have tumor biopsies and genetic testing on their blood and biopsy samples.

The study will continue until the participants' cancer progresses or they experience side effects that make it difficult to continue. After stopping the treatment, participants will have follow-up visits to monitor their health. These visits will occur 2 and 6 weeks after stopping treatment, and then every 3 months, which may include imaging scans. Some follow-up visits may be conducted over the phone, with necessary scans done at the participant's doctor's office.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of thymoma or thymic carcinoma.
  • Have previously been treated with at least one platinum-based chemotherapy regimen.
  • The cancer must have returned or worsened after previous treatment.
  • Have measurable disease, meaning at least one tumor that can be measured by scans.
  • Be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ and bone marrow function as determined by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 2 months after the last dose.
  • Participants with previously treated brain or CNS metastases are eligible if they have recovered from any side effects of treatment and do not require steroids.
  • Must be able to understand and sign a written informed consent document.

Exclusion Criteria

  • History of severe allergic reactions to similar drugs.
  • Recent history of severe asthma or anaphylaxis.
  • Previous treatment with PD-1 or PD-L1 inhibitors is not allowed.
  • Recent anticancer treatment or major surgery within 14 days before starting the study.
  • Active brain or CNS metastases causing symptoms or requiring treatment.
  • Active or history of autoimmune diseases that could worsen with treatment, except for certain conditions like type I diabetes or well-controlled thyroid disease.
  • Currently taking high doses of steroids or other immunosuppressive medications.
  • Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV.
  • History of organ transplantation requiring immunosuppression.
  • Pregnant or breastfeeding women.
  • Known alcohol or drug abuse.
  • Uncontrolled medical conditions that could interfere with the study.
  • Recent administration of a live vaccine, except for COVID-19 vaccination.

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