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Bifunctional Fusion Protein

Bintrafusp Alfa for Thymic Cancer

Q: Is this medical investigation pioneering any new techniques?

<p>Currently, Merck Sharp &#x26; Dohme LLC are running 22 trials for M7824 in 21 countries and 59 cities. This drug first underwent clinical exams in 2016 with 829 participants completing Phase 1 successfully. Since then, 6 additional studies have been conducted.</p>

Phase 2

Recruiting

Led By Arun Rajan, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have had at least one prior line of platinum-based chemotherapy

Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST 1.1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the treatment until disease progression/recurrence

Awards & highlights

Study Summary

This trial is for people with thymoma or thymic cancer whose disease returned or progressed after treatment with at least one platinum-containing chemotherapy treatment plan. The objective is to see if bintrafusp alfa (M7824) is an effective treatment.

Who is the study for?

Adults aged 18+ with thymoma or thymic carcinoma that has returned or progressed after platinum-based chemotherapy. They must have measurable disease, adequate organ and marrow function, no severe autoimmune diseases, no recent major surgeries or use of certain drugs, and not be pregnant.Check my eligibility

What is being tested?

The trial is testing bintrafusp alfa (M7824), a new drug for thymoma and thymic carcinoma. Participants will receive the drug every two weeks via IV infusion and undergo regular health assessments including blood tests, scans, heart/lung/thyroid function tests, and possibly biopsies.See study design

What are the potential side effects?

Specific side effects are not listed in the provided information but may include typical reactions to immune-stimulatory agents such as inflammation in organs, allergic reactions similar to other compounds in its class, fatigue from treatment infusions, potential blood disorders from bone marrow impact.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had platinum-based chemotherapy before.

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My cancer can be measured by scans.

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My cancer is confirmed as thymoma or thymic carcinoma.

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I am fully active and can carry on all my pre-disease activities without restriction.

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My liver enzymes are within the required range.

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My liver enzymes are within the required range, even with liver metastasis.

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I have had platinum-based chemotherapy before and my cancer has worsened and cannot be removed by surgery.

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My condition cannot be treated with surgery.

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I am 18 years old or older.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I am 18 years old or older.

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My cancer is officially diagnosed as thymoma or thymic carcinoma.

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My bilirubin levels are within the normal range, or up to 3 times higher if my cancer has spread to the liver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of the treatment until disease progression/recurrence

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of the treatment until disease progression/recurrence

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the treatment until disease progression/recurrence for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective response rate

Secondary outcome measures

Duration of response, progression free survival & overall survival

Safety & tolerability of M7824

Side effects data

From 2023 Phase 1 & 2 trial • 21 Patients • NCT04247282

43%

Oral hemorrhage

36%

Constipation

36%

Fatigue

36%

Lymphocyte count decreased

36%

Epistaxis

29%

Dysphagia

29%

Weight loss

21%

Hyperglycemia

21%

Pruritus

21%

Wound infection

21%

Anemia

14%

Hyperthyroidism

14%

Lipase increased

14%

Rash acneiform

14%

White blood cell decreased

14%

Creatinine increased

14%

Gait disturbance

14%

Rash maculo-papular

14%

Tumor hemorrhage

14%

Alanine aminotransferase increased

14%

Oral pain

Palpitations

Aspartate aminotransferase increased

Blood bilirubin increased

Cough

Flu like symptoms

Hyponatremia

Hypoxia

Intraoperative head and neck injury

Vaccination site lymphadenopathy

Gastrointestinal disorders - Other, Sialadenitis

Hematuria

Respiratory failure

Atrial fibrillation

CPK increased

Dermatitis radiation

GGT increased

Hypermagnesemia

Hypophosphatemia

Nausea

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify

Peripheral sensory neuropathy

Aphonia

Dehydration

Edema limbs

Mucositis oral

Tumor pain

Lung infection

Sinus tachycardia

Vasculitis

Alkaline phosphatase increased

Dysarthria

Dysesthesia

Dysgeusia

Hypothyroidism

Pain

Skin ulceration

Stroke

100%

80%

60%

40%

20%

Study treatment Arm

Arm A, Cohort 1 Bintrafusp Alfa (M7824) 1200 mg (Days 1, 15)

Arm B,Cohort 1 M7824 1200mg+TriAdVaccine 5x10e^11viral Particles(ETBX-011,ETBX-051&ETBX-061) (Day 1)

Arm C, Cohort 1 M7824 1200mg + TriAd Vaccine 5x10e^11 Viral Particles (Day 1)+N-803 15mcg/kg (Day 1)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Bintrafusp alfa (M7824)Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

M7824

2020

Completed Phase 2

~350

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,816 Total Patients Enrolled

2 Trials studying Thymic Cancer

83 Patients Enrolled for Thymic Cancer

Arun Rajan, M.D.Principal InvestigatorNational Cancer Institute (NCI)

15 Previous Clinical Trials

3,698 Total Patients Enrolled

1 Trials studying Thymic Cancer

53 Patients Enrolled for Thymic Cancer

Media Library

Bintrafusp Alfa (M7824) (Bifunctional Fusion Protein) Clinical Trial Eligibility Overview. Trial Name: NCT04417660 — Phase 2

Thymic Cancer Research Study Groups: Bintrafusp alfa (M7824)

Thymic Cancer Clinical Trial 2023: Bintrafusp Alfa (M7824) Highlights & Side Effects. Trial Name: NCT04417660 — Phase 2

Bintrafusp Alfa (M7824) (Bifunctional Fusion Protein) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04417660 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this trial?

"Affirmative. According to records on clinicaltrials.gov, this medical trial is actively recruiting participants; it was launched on December 26th 2020 and last modified October 15th 2022. The research team needs 38 volunteers from one centre in total."

Answered by AI

Has the FDA granted authorization for M7824 to be used?

"Our company's assessment of M7824 safety is a 2, as there are existing data points confirming its security but none supporting efficacy."

Answered by AI

Is this medical investigation pioneering any new techniques?

"Currently, Merck Sharp & Dohme LLC are running 22 trials for M7824 in 21 countries and 59 cities. This drug first underwent clinical exams in 2016 with 829 participants completing Phase 1 successfully. Since then, 6 additional studies have been conducted."

Answered by AI

Are there still opportunities to become involved in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical trial is still accepting new participants after initially being posted on December 26th 2020 and last edited on October 15th 2022. The research team aims to enlist 38 individuals from a single site."

Answered by AI

Has M7824 previously been tested through any other clinical experiments?

"Currently, there are 22 studies researching M7824 with 2 Phase 3 trials. While many of the experiments involving this medication occur in Henderson, Nevada; other sites around the world have also joined to form a total 285 locations running these trials."

Answered by AI