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PD-L1/TGFbetaRII Inhibitor
Immunotherapy with Bintrafusp Alfa for Breast Cancer
Phase 1
Waitlist Available
Led By Rashmi K Murthy
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female subjects must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry and be using highly effective contraception
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial studies how well M7824 works in treating patients with stage II-III HER2 positive breast cancer. M7824 is an immunotherapy that may help the body's immune system attack the cancer.
Who is the study for?
This trial is for women and men with stage II-III HER2 positive breast cancer, who have not been treated with PD-1/PD-L1 or CTLA-4 inhibitors. Participants must have a tumor size of at least 2 cm, no distant metastasis, proper liver and kidney function, an acceptable blood count, and use effective contraception. They should be able to follow the study protocol.Check my eligibility
What is being tested?
The trial is testing M7824 (Bintrafusp Alfa), which may boost the immune system's ability to fight cancer and prevent tumor growth in patients with specific breast cancer. It's an early-phase study to see how well this immunotherapy works.See study design
What are the potential side effects?
Potential side effects of M7824 could include typical reactions related to immunotherapies such as fatigue, skin reactions, inflammation in various organs like lungs or intestines (colitis), hormonal gland problems (like thyroid issues), or infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and use effective birth control or cannot become pregnant.
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I am fully active or can carry out light work.
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My tumor is at least 2 cm big and has not spread to distant parts of my body.
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My breast cancer is HER2 positive according to ASCO-CAP guidelines.
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My kidneys are functioning well, with a creatinine clearance rate of at least 60 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in tumor-infiltrating lymphocytes (TIL) percentage
Electrocardiogram parameters
Eye symptoms (and signs if symptoms warranted additional evaluation)
+2 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (M7824)Experimental Treatment1 Intervention
Participants receive anti-PD-L1/TGFbetaRII fusion protein M7824 IV over 1 hour on days 1 and 15. During days 28-56 participants receive planned neoadjuvant chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bintrafusp alfa
Not yet FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,782 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,647 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Rashmi K MurthyPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active tuberculosis.You have had an allergic reaction to M7824 or any of its ingredients.You have a history of a weak immune system from birth.I am willing and able to follow the study's requirements, including treatments and visits.I haven't taken immunosuppressive drugs in the last 28 days.I have or had inflammatory bowel disease.I have inflammatory breast cancer.Your hemoglobin level is at least 9 grams per deciliter.Your platelet count is at least 100,000 per mm^3.I am not pregnant and use effective birth control or cannot become pregnant.I have been treated with a PD-1, PD-L1, or CTLA-4 inhibitor before.I have had an autoimmune disease in the last 2 years.I have not received a live vaccine within 30 days before joining the study or before getting M7824.I have seizures that are not controlled by medication.I haven't had major surgery, except for a biopsy, in the last 4 weeks.I have a history of bleeding disorders.I am fully active or can carry out light work.My tumor is at least 2 cm big and has not spread to distant parts of my body.My breast cancer is HER2 positive according to ASCO-CAP guidelines.My kidneys are functioning well, with a creatinine clearance rate of at least 60 mL/min.I am using a highly effective method of birth control.I have had an organ transplant and take medicine to prevent rejection.You have a certain level of a type of white blood cell called neutrophils in your blood.I do not have any uncontrolled illnesses.I have had cancer before, but it fits the exceptions.I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.Your AST and ALT levels in the blood are not more than 2.5 times the normal limit.Your heart takes too long to recharge between beats.Your bilirubin levels in the blood are not higher than 1.5 times the normal limit, unless you have Gilbert's syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the estimated populace for this trial's enrollment?
"As of October 12th 2022, this experiment has concluded its patient recruiting period. Initiated on August 3rd 2018 and modified lastly in the fall, if you are exploring other research opportunities there are currently 2287 breast-related studies as well as 22 trials actively seeking participants for Bintrafusp Alfa."
Answered by AI
Has Bintrafusp Alfa acquired official sanction from the FDA?
"Taking into account its Phase 1 status, there is only scarce evidence for the safety of Bintrafusp Alfa. Consequently, our team at Power assigned it a rating of 1 on the scale from 1 to 3."
Answered by AI
Does this clinical trial currently have availability for new participants?
"This investigation is no longer seeking participants. It was initially launched on August 3rd 2018, with the last update made October 12th 2022. Those looking for other trials may find 2287 studies related to breast health and 22 clinical investigations exploring Bintrafusp Alfa currently accepting patients."
Answered by AI
Has Bintrafusp Alfa been tested in other scientific experiments prior to this one?
"Currently, there are 22 medical research projects centred around Bintrafusp Alfa. Of those studies, 2 have entered Phase 3 clinical trials. These experiments can be found in a variety of locations, with 285 sites offering this treatment located mainly within Houston, Texas."
Answered by AI
Is this study a pioneering endeavor in its field?
"Research for Bintrafusp Alfa was initiated in 2016, with the first study being sponsored by Merck Sharp & Dohme LLC and involving 829 participants. Following successful completion of Phase 1 trials, 22 current medical studies are occurring worldwide across 59 cities and 21 countries."
Answered by AI
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