AzTrials
AzTrials

Triple Negative Breast NeoplasmsPhase 2NCT04489940

Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer

A Phase 2 study testing Bintrafusp alfa in people with Triple Negative Breast Neoplasms, run by EMD Serono Research & Development Institute, Inc. at 45 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The main purpose of this study was to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Neoplasms
What is being tested?
Bintrafusp alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
45 sitesin 6 countries
Study dates
12 Oct 2020to 8 Jul 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Study participants have histologically or cytologically confirmed TNBC
  • Absence of human epidermal growth factor receptor 2 (HER2), estrogen receptor, and progesterone receptor expression must be documented (criteria for defining TNBC are outlined in the protocol)
  • Participants must have received at least one line of systemic therapy for metastatic disease and have progressed on the line of therapy immediately prior to study entry. There is no limit to the number of prior therapies
  • Participants may prescreen for HMGA2 expression while on preceding treatment, however screening should only occur if in the opinion of the Investigator, the participant would likely be eligible for study within 6 months
  • Participants must have measurable disease
  • Availability of either archival tumor tissue or fresh core or excisional biopsy of a tumor lesion (primary or metastatic, excluding bone biopsies) is mandatory to determine HMGA2 expression level prior to enrollment
Show all 13Show fewer
  • HMGA2 high tumor expression is required and will be determined by a central lab
  • Participants who have Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
  • Participants have a life expectancy greater than or equal to (>=) 12 weeks as judged by the Investigator at study start
  • Participants have adequate hematological, hepatic and renal and coagulation function as defined in the protocol
  • Participants with known Human Immunodeficiency Virus (HIV) infections are in general eligible if the criteria as defined in the protocol are met (Food and Drug Administration [FDA] Guidance on Cancer Clinical Trial Eligibility, March 2019)
  • Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections are in general eligible if the criteria as defined in the protocol are met (FDA Guidance on Cancer Clinical Trial Eligibility, March 2019)
  • Other protocol defined inclusion criteria could apply

Who cannot join

  • Participants with active central nervous system (CNS) metastases causing clinical symptoms or metastases that require therapeutic intervention are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study intervention
  • Participants must not have received prior cancer treatment with any other immunotherapy or checkpoint inhibitors, or any other immune-modulating monoclonal antibody
  • Participants that received any organ transplantation, including stem-cell transplantation, but with the exception of transplants that do not require immunosuppression
  • Participants with significant acute or chronic infections
  • Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
  • Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
  • Other protocol defined exclusion criteria could apply

Trial locations and contacts

45 sites in 6 countries.

45 sites in 6 countries

United States15 sites

  • New York Oncology Hematology, P.C. - Albany

    Albany, New York, 12206

  • Texas Oncology, P.A. - Austin - Austin Central Cancer Center

    Austin, Texas, 78731

  • Charleston Hematology Oncology Associates, PA

    Charleston, South Carolina, 29414

  • TheOhio State University, Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212

  • Texas Oncology, P.A. - Medical City Dallas - Pediatric Hematology/Oncology

    Dallas, Texas, 75230

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • The West Clinic

    Germantown, Tennessee, 38138

  • Mayo Clinic-Jacksonville

    Jacksonville, Florida, 32224

  • UPMC Hillman Cancer Center - Hillman Cancer Center

    Monroeville, Pennsylvania, 15146

  • Medical Oncology Hematology Consultants, PA, Helen F. Graham Cancer Center, Suite 3400

    Newark, Delaware, 19713-2055

  • Virginia Oncology Associates - Hampton

    Norfolk, Virginia, 23502

  • Texas Oncology, P.A. - Plano

    Plano, Texas, 75075

  • Texas Oncology-San Antonio Stone Oak

    San Antonio, Texas, 78240

  • Maryland Oncology Hematology, P.A.

    Silver Spring, Maryland, 20904

  • Texas Oncology, P.A. - Tyler

    Tyler, Texas, 75702

Other trials in United States

Russia9 sites

  • SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary" - Chemotherapy

    Arkhangelsk

  • SBIH " Clinical Oncological Dispensary # 1" - Location

    Krasnodar

  • SBIH " Clinical Oncological Dispensary 1" - Location

    Krasnodar

  • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin" - Moscow Cancer Research Centre

    Moscow

  • BHI of Omsk region "Clinical Oncology Dispensary"

    Omsk

  • LLC "ClinicaUZI4D"

    Pyatigorsk

  • FSBI "Clinical Research and Practical Center for specialized medical care (oncology)"

    Saint Petersburg

  • Tomsk Research Instutite of Oncology - Chemotherapy

    Tomsk

  • SBIH Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan

    Ufa

Other trials in Russia

Italy7 sites

  • IEO Istituto Europeo di Oncologia

    Milan

  • Ospedale San Raffaele

    Milan

  • Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento di Senologia

    Naples

  • IOV - Istituto Oncologico Veneto IRCCS - Oncologia Medica 2

    Padova

  • Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II

    Pisa

  • Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica

    Roma

  • Istituto Clinico Humanitas

    Rozzano

Other trials in Italy

France6 sites

  • Centre François Baclesse - Pathologies Gynecologiques

    Caen

  • Centre Léon Bérard

    Lyon

  • Hôpital Privé du Confluent SAS

    Nantes

  • Groupe Hospitalier Diaconesses - Hôpital De La Croix Saint Simon - service d'oncologie medicale

    Paris

  • CARIO - Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie

    Plérin

  • Institut Curie - Centre René Huguenin - Service d'Oncologie Médicale

    Saint-Cloud

Other trials in France

Spain5 sites

  • Hospital Universitario Reina Sofia - Dept of Oncology

    Córdoba

  • Hospital General Universitario Gregorio Marañon - Servicio de Oncologia Medica

    Madrid

  • Hospital Ruber Internacional - Servicio de Oncologia

    Madrid

  • Hospital Universitario Ramon y Cajal - Servicio de Oncologia

    Madrid

  • Hospital Universitario Virgen del Rocio - Servicio de Oncologia

    Seville

Other trials in Spain

Belgium3 sites

  • Universitair Ziekenhuis Brussel - Geriatrie

    Brussels

  • UZ Leuven

    Leuven

  • AZ Sint-Maarten - PARENT

    Mechelen

Other trials in Belgium

About this study

Official title: A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With HMGA2-expressing Triple Negative Breast Cancer

The main purpose of this study was to evaluate bintrafusp alfa monotherapy in participants with triple negative breast cancer (TNBC) who express high levels of HMGA2 as determined by a centralized reverse transcriptase-polymerase chain reaction (RT-PCR) test.

Being tested
Bintrafusp alfa
Keywords
M7824, Bintrafusp alfa, Programmed death-ligand 1, Transforming growth factor-β (TGF-β), Breast Cancer, MS200647
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bintrafusp alfaDrug

    Also called M7824

    Participants received an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.

Study groups in NCT04489940
Study groupRoleWhat they receive
Bintrafusp alfaExperimentalNot described
Receives: Drug: Bintrafusp alfa

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC)

    The ORR was defined as the percentage of participants with a confirmed objective response of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 as assessed by IRC. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.

    Measured: Time from first study intervention up to 321 days

Secondary outcomes (12)

  1. Duration of Response (DOR) According to RECIST Version 1.1

    DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: At least a 20 percent (%) increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by IRC.

    Measured: From first documented objective response to PD or death due to any cause, assessed up to 321 days

  2. Durable Response Rate (DRR) of at Least 6 Months Assessed by an Independent Review Committee (IRC)

    DRR was defined as the number of participants having a DOR of at least 6 months, out of the total number of participants.

    Measured: Time from first study intervention up to 321 days

  3. Progression-Free Survival (PFS) According to RECIST Version 1.1 Assessed by the IRC

    PFS was defined as the time from first study intervention until the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The tumor response was determined according to RECIST version 1.1 and assessed by the IRC.

    Measured: Time from first study intervention up to until the first documentation of PD or death, assessed up to 321 days

  4. Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator

    DOR was defined for participants with a confirmed objective response as the time from first documentation of a confirmed objective response (CR or PR) according to RECIST 1.1 to the date of first documentation of objective PD or death due to any cause, whichever occurs first. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in sum of longest diameter (SLD) of all lesions. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. DOR was determined according to RECIST v1.1 and assessed by investigator.

    Measured: From first documented objective response to PD or death due to any cause, assessed up to 321 days

  5. Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by the Investigator

    The ORR was defined as the percentage of participants with a confirmed objective response of Complete Response (CR) or Partial Response (PR) according to RECIST v1.1 as assessed by investigator. CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in sum of longest diameter (SLD) of all lesions.

    Measured: Time from first study intervention up to 321 days

  6. Durable Response Rate (DRR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

    DRR was defined as the number of participants having a DOR of at least 6 months, out of the total number of participants.

    Measured: Time from first study intervention up to 321 days

  7. Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator

    PFS was defined as the time from first study intervention until the first documentation of PD or death due to any cause in the absence of documented PD, whichever occurred first. PD: At least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. The tumor response was determined according to RECIST version 1.1 and assessed by the investigator.

    Measured: Time from first study intervention up to the first documentation of PD or death, assessed up to 321 days

  8. Overall Survival (OS)

    OS was defined as the time from first day of study treatment to death due to any cause. Participants without documented death at the time of analysis are censored at the date of the last follow-up. OS was summarized by Kaplan-Meier (KM) methods.

    Measured: Time from the first dose of study drug until occurrence of death due to any cause, assessed up to 321 days

  9. Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Related AEs, and Adverse Events of Special Interest (AESIs)

    An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether considered related to the medicinal product or protocol-specified procedure. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAE was defined as events with onset date or worsening during the on-treatment period. TEAEs included serious TEAEs and non-serious TEAEs. The AESIs considered in this study are infusion-related reactions including immediate hypersensitivity, immune-related adverse events, skin adverse events, bleeding events and anemia.

    Measured: Time from first study intervention up to 321 days

  10. Immediate Observed Serum Concentration at End of Infusion (Ceoi) of Bintrafusp Alfa

    Ceoi was the serum concentration observed immediately at the end of infusion. This was taken directly from the observed bintrafusp alfa concentration-time data.

    Measured: Pre-dose, End of Infusion from Day 1 to 321

  11. Serum Trough Concentration Levels (Ctrough) of Bintrafusp Alfa

    Ctrough was the serum concentration observed immediately before next dosing.

    Measured: Pre-dose, End of Infusion from Day 1 to 321

  12. Number of Participants With Positive Anti-Drug Antibody (ADA) of Bintrafusp Alfa

    The detection of antibodies to bintrafusp alfa was performed using a validated ADA assay method with tiered testing of screening, confirmatory and titration.

    Measured: Pre-dose, End of Infusion from Day 1 to 321

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2020
  2. Study start12 Oct 2020
  3. Primary completion27 Jan 2022
  4. Study completion8 Jul 2022

Why it stopped: The study was prematurely discontinued by the sponsor due to probability of success which was too low to justify the continuation of recruitment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04489940
Sponsor's protocol ID
MS200647_0020
Other IDs
2019-004833-18, 2019
Status last verified
Mar 2023
First submitted
27 Jul 2020
Last updated
10 Apr 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bintrafusp alfa in people with Triple Negative Breast Neoplasms, run by EMD Serono Research & Development Institute, Inc. at 45 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Russia, Italy, France, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by an Independent Review Committee (IRC) (time frame: Time from first study intervention up to 321 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04489940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in