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Bifunctional Fusion Protein
Bintrafusp Alfa for Thymic Cancer
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
Must not have
Major surgery within 14 days before treatment
Known history of testing positive for HIV or testing positive for HIV at screening or known acquired immunodeficiency syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of the treatment until disease progression/recurrence
Awards & highlights
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.
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.
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 belowSelect...
I have had platinum-based chemotherapy before.
Select...
My cancer can be measured by scans.
Select...
My cancer is confirmed as thymoma or thymic carcinoma.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
My liver enzymes are within the required range.
Select...
My liver enzymes are within the required range, even with liver metastasis.
Select...
I have had platinum-based chemotherapy before and my cancer has worsened and cannot be removed by surgery.
Select...
My condition cannot be treated with surgery.
Select...
I am 18 years old or older.
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I am 18 years old or older.
Select...
My cancer is officially diagnosed as thymoma or thymic carcinoma.
Select...
My bilirubin levels are within the normal range, or up to 3 times higher if my cancer has spread to the liver.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had major surgery in the last 14 days.
Select...
I have tested positive for HIV or have AIDS.
Select...
I have never been treated with PD-1 or PD-L1 inhibitors.
Select...
I have an autoimmune disease that could worsen with immune-stimulating treatments.
Select...
I am taking more than 10 mg of corticosteroids daily.
Select...
I haven't had cancer treatment in the last 14 days.
Select...
I have had an organ or stem-cell transplant.
Select...
I do not have any severe illnesses that would stop me from following the study's requirements.
Select...
I have not received a live vaccine in the last 4 weeks.
Select...
I have not had any other cancer in the past 3 years.
Select...
I do not have any active infections needing treatment.
Select...
I am not currently taking any drugs that are not allowed in the study.
Select...
I haven't used hormonal cancer therapy in the last 7 days.
Select...
I have brain or CNS cancer spread causing symptoms or needing treatment.
Select...
I am unwilling to receive blood products even if needed for my treatment.
Select...
I have lasting side effects from previous treatments that are moderate or worse.
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
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 2024 Phase 3 trial • 304 Patients • NCT0363170634%
Pruritus
32%
Rash
30%
Anaemia
20%
Fatigue
19%
Dyspnoea
19%
Pyrexia
18%
Haemoptysis
17%
Asthenia
17%
Decreased appetite
16%
Diarrhoea
15%
Aspartate aminotransferase increased
15%
Cough
13%
Gamma-glutamyltransferase increased
13%
Arthralgia
13%
Nausea
13%
Alanine aminotransferase increased
12%
Blood alkaline phosphatase increased
11%
Hypothyroidism
11%
Insomnia
11%
Rash maculo-papular
11%
Constipation
11%
Hypoalbuminaemia
10%
Epistaxis
9%
Oedema peripheral
9%
Vomiting
9%
Headache
9%
Hyperglycaemia
8%
Dizziness
8%
Lipase increased
8%
Keratoacanthoma
7%
Hyponatraemia
7%
Myalgia
7%
Urinary tract infection
7%
Hypotension
7%
Weight decreased
6%
Pneumonia
6%
Dry Skin
6%
Blood bilirubin increased
6%
Blood creatinine increased
6%
Upper respiratory tract infection
6%
Amylase increased
6%
Hyperuricaemia
5%
Hyperkeratosis
5%
Rash pruritic
5%
Productive cough
5%
Back pain
5%
Chest pain
4%
Hyperthyroidism
4%
Disease progression
3%
Hypomagnesaemia
3%
Hypokalaemia
3%
Pneumothorax
3%
Squamous cell carcinoma of skin
3%
Dyspepsia
2%
Hypertension
2%
Pulmonary haemorrhage
2%
Keratoacanthom
2%
Abdominal pain upper
1%
Fluid overload
1%
Sudden death
1%
Acute myocardial infarction
1%
Infusion related reaction
1%
Platelet count decreased
1%
Aplastic anaemia
1%
Autoimmune haemolytic anaemia
1%
Fall
1%
Iron deficiency anaemia
1%
Oesophageal ulcer
1%
Death
1%
Arrhythmia
1%
Influenza
1%
Skin infection
1%
Myopathy
1%
Hypercalcaemia
1%
Troponin increased
1%
Bladder cancer
1%
Cancer pain
1%
Tumour haemorrhage
1%
Skin toxicity
1%
Stevens-Johnson syndrome
1%
Blood thyroid stimulating hormone increased
1%
Coronary artery disease
1%
Malaise
1%
Infection
1%
Pneumonia staphylococcal
1%
Fractured sacrum
1%
Chronic obstructive pulmonary disease
1%
Hypoxia
1%
Pleural effusion
1%
Pneumonitis
1%
Drug eruption
1%
Eczema
1%
Toxic skin eruption
1%
Embolism
1%
Superior vena cava syndrome
1%
Agranulocytosis
1%
Angina pectoris
1%
Fracture pain
1%
Spondylitis
1%
Cerebral infarction
1%
Renal failure
1%
Lichen planus
1%
Immune-mediated enterocolitis
1%
Pericardial effusion
1%
Immune thrombocytopenia
1%
Adrenal insufficiency
1%
Oral candidiasis
1%
Bile duct stone
1%
Cholecystitis
1%
Immune-mediated nephritis
1%
Aortic aneurysm
1%
Transaminases increased
1%
Bacterial sepsis
1%
Bronchitis
1%
Strangulated incisional hernia
1%
Thoracic vertebral fracture
1%
Encephalitis
1%
Pulmonary sepsis
1%
Diabetes mellitus
1%
Sciatica
1%
Asthma
1%
Dermatitis bullous
1%
Hypersensitivity
1%
Cholestasis
1%
Hyperthermia
1%
Hepatotoxicity
1%
Lower respiratory tract infection
1%
Colitis
1%
Viral upper respiratory tract infection
1%
Urinary tract infection bacterial
1%
Pancreatitis
1%
General physical health deterioration
1%
Duodenitis
1%
Upper gastrointestinal haemorrhage
1%
Gastric ulcer haemorrhage
1%
Gastrointestinal haemorrhage
1%
Hepatitis
1%
Hip fracture
1%
Bladder transitional cell carcinoma
1%
Erythema
1%
Pemphigoid
1%
Respiratory failure
1%
Interstitial lung disease
1%
Erythema multiforme
1%
Orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
M7824
Pembrolizumab
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
2018
Completed Phase 3
~660
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,841 Previous Clinical Trials
41,002,851 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
3,703 Total Patients Enrolled
1 Trials studying Thymic Cancer
53 Patients Enrolled for Thymic Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 14 days.I have tested positive for HIV or have AIDS.My organs and bone marrow are functioning well.You have a history of alcohol or drug abuse.I have never been treated with PD-1 or PD-L1 inhibitors.I have had platinum-based chemotherapy before.I have an autoimmune disease that could worsen with immune-stimulating treatments.I am taking more than 10 mg of corticosteroids daily.I haven't had cancer treatment in the last 14 days.I have had an organ or stem-cell transplant.I do not have any severe illnesses that would stop me from following the study's requirements.My cancer can be measured by scans.I have not received a live vaccine in the last 4 weeks.My cancer is confirmed as thymoma or thymic carcinoma.I am fully active and can carry on all my pre-disease activities without restriction.I have not had any other cancer in the past 3 years.I haven't taken immunosuppressive drugs in the last 14 days.My liver enzymes are within the required range.My liver enzymes are within the required range, even with liver metastasis.I have had platinum-based chemotherapy before and my cancer has worsened and cannot be removed by surgery.My bilirubin levels are within the normal range, or up to 3 times higher if my cancer has spread to the liver.I do not have any active infections needing treatment.My condition cannot be treated with surgery.I am 18 years old or older.I am not currently taking any drugs that are not allowed in the study.I am fully active and can carry on all my pre-disease activities without restriction.I am 18 years old or older.Platelets: >=> 100,000/mm3 or >100 x 10(9)/L.You have had allergic reactions to drugs that are similar to bintrafusp alfa.You have experienced a severe allergic reaction called anaphylaxis or have had uncontrollable asthma in the past 5 months.I haven't used hormonal cancer therapy in the last 7 days.I have brain or CNS cancer spread causing symptoms or needing treatment.I am unwilling to receive blood products even if needed for my treatment.You have taken any experimental drug within the past 14 days.I have lasting side effects from previous treatments that are moderate or worse.My cancer is officially diagnosed as thymoma or thymic carcinoma.You have a measurable lesion by RECIST 1.1.1.1.1.1.1.1.My bilirubin levels are within the normal range, or up to 3 times higher if my cancer has spread to the liver.
Research Study Groups:
This trial has the following groups:- Group 1: Bintrafusp alfa (M7824)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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