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NCT04417660 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Thymic Cancer and Thymic Epithelial Tumor, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
9
Enrollment target
1
Study location

NCT04417660 is a Phase 2 study of Thymic Cancer and Thymic Epithelial Tumor that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 9 participants, below the 21-participant average among 4 other Thymic Cancer trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04417660, a Phase 2 study of Thymic Cancer and Thymic Epithelial Tumor, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
9 participants
Enrollment target
1
Study location

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.

Interventions

  • DRUG M7824

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2020-12-26
Est. Completion 2026-12-31
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT04417660

The ClinicalTrials.gov registry entry for NCT04417660 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 21-participant average among 4 other Thymic Cancer trials with a reported enrollment target (57% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Thymic Cancer appearing as the primary indexed condition, and to 1 intervention - of which M7824 is the first listed.

NCT04417660 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT04417660 about?

NCT04417660 is a clinical study titled "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...

What is the current status of trial NCT04417660?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2020-12-26. Estimated completion is 2026-12-31.

What conditions does trial NCT04417660 study?

This clinical trial studies the following conditions: Thymic Cancer, Thymic Epithelial Tumor, Recurrent Thymoma.

What interventions are being tested in trial NCT04417660?

The interventions under investigation include: M7824 (DRUG).

Who is sponsoring clinical trial NCT04417660?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04417660 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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