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Anatomic Stage II Breast Cancer AJCC v8Phase 1NCT03620201

M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer

A Phase 1 study testing Bintrafusp Alfa in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial studies how well anti-PD-L1/TGFbetaRII fusion protein M7824 (M7824) works in treating patients with stage II-III HER2 positive breast cancer. Immunotherapy with M7824 may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
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
20 participants
Where
1 siteUnited States
Study dates
3 Aug 2018to 18 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Written informed consent and any locally-required authorization (e.g., Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Tumor size >= 2 cm and with no known distant metastatic disease
  • HER2+, breast cancer as defined by American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines: HER2/neu is defined as positive: immunohistochemistry (IHC) 3+ based on circumferential membrane staining that is complete, intense in situ hybridization (ISH) positive based on: single-probe average HER2 copy number >= 6.0 signals/cell. Dual-probe HER2/CEP17 ratio >= 2.0; with an average HER2 copy number >= 4.0 signals/cell, dual-probe HER2/CEP17 ratio >= 2.0; with an average HER2, copy number < 4.0 signals/cell, dual-probe HER2/CEP17 ratio < 2.0; with an average HER2, copy number >= 6.0 signals/cell, neoadjuvant systemic therapy is planned and will include HER2 targeted therapy in combination with chemotherapy of physician's choice
  • Hemoglobin >= 9 g/dL
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1500 per mm^3)
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  • Platelet count >= 100 x 10^9/L (>= 100,000 per mm^3)
  • Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only upon treating physician, principal investigator (PI) or co-PI approval
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal
  • Serum creatinine clearance >= 60 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance
  • Female subjects must either be of non-reproductive potential (ie, post-menopausal by history: >= 60 years old and no menses for >= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry and be using highly effective contraception (that is, methods with a failure rate of less than 1% per year) for both male and female subjects if the risk of conception exists (Note: The effects of the trial treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use highly effective contraception). Male subjects on study must also use highly effective contraception. Highly effective contraception must be used 30 days prior to first trial treatment administration, for the duration of trial treatment, and at least for 4 months after stopping trial treatment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this trial, the treating physician should be informed immediately
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Who cannot join

  • Involvement in the planning and/or conduct of the study (applies to both EMD Serono staff and/or staff at the study site)
  • Participation in another clinical study with an investigational product during the last 1 month prior to initiation of therapy
  • Any previous treatment with a PD-1 or PD-L1 inhibitor or CTLA-4 inhibitor
  • History of another primary malignancy except for:
  • Malignancy treated with curative intent and with no known active disease >= 1 year before the first dose of study drug and of low potential risk for recurrence
  • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
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  • Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ
  • Has received therapy for this current diagnosis of breast cancer including endocrine therapy or chemotherapy
  • Mean QT interval corrected for heart rate (QTc) >= 470 ms
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of M7824, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
  • Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • History of primary immunodeficiency
  • History of organ transplants that require immunosuppression
  • History of hypersensitivity to M7824 or any excipient of M7824
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses, known history of human immunodeficiency virus (HIV) and/or viral hepatitis, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
  • Active tuberculosis
  • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving M7824
  • Female subjects who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
  • Subjects with uncontrolled seizures
  • Concurrent treatment with non-permitted drugs and other interventions
  • Any major surgery for any reason, except diagnostic biopsy, within 4 weeks of the enrollment
  • Inflammatory breast cancer
  • History of conditions associated with bleeding diatheses

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Pilot Single Arm Open Label Trial Evaluating M7824 (Anti-PD-L1/TGF-Beta TRAP) in a Window Setting in Patients With Stage II-III HER2/Neu Positive (HER2+) Breast Cancer (BC)

This phase I trial studies how well anti-PD-L1/TGFbetaRII fusion protein M7824 (M7824) works in treating patients with stage II-III HER2 positive breast cancer. Immunotherapy with M7824 may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the change in tumor-infiltrating lymphocytes (TIL) percentage pre and post M7824 therapy.

SECONDARY OBJECTIVES:

  1. To evaluate the safety and tolerability of M7824 in early stage breast cancer (stage II/III).

II. To evaluate pathological response at the time of surgery after 2 doses of M7824 followed by neoadjuvant (human epidermal growth factor receptor 2) HER2 targeted therapy in combination with chemotherapy of physician's choice.

EXPLORATORY OBJECTIVES:

  1. To evaluate imaging based response to M7824. II. To evaluate potential systemic and tumor based predictive biomarker candidates of response.

III. To evaluate immune responses induced by exposure to M7824 systemically and in tumor microenvironment (TME).

OUTLINE:

Patients receive anti-PD-L1/TGFbetaRII fusion protein M7824 intravenously (IV) over 1 hour on days 1 and 15. During days 28-56 patients receive planned neoadjuvant chemotherapy.

Being tested
Bintrafusp Alfa

What participants receive

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

  • Bintrafusp AlfaDrug

    Also called Anti-PDL1/TGFb Trap MSB0011359C, M7824, MSB0011359C

    Given IV

Study groups in NCT03620201
Study groupRoleWhat they receive
Treatment (M7824)ExperimentalParticipants 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.
Receives: Drug: Bintrafusp Alfa

What is being measured

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

  1. Change in tumor-infiltrating lymphocytes (TIL) percentage

    Measured: Baseline up to post M7824 therapy

  2. Laboratory parameters

    Measured: Up to 1 year

  3. Eye symptoms (and signs if symptoms warranted additional evaluation)

    Measured: Up to 1 year

  4. Vital signs

    Measured: Up to 1 year

  5. Electrocardiogram parameters

    Measured: Up to 1 year

Timeline

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

  1. First posted8 Aug 2018
  2. Study start3 Aug 2018
  3. Primary completion18 Oct 2024
  4. Study completion18 Oct 2024

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03620201
Sponsor's protocol ID
2017-0502
Other IDs
NCI-2018-01184, 2017-0502
Status last verified
Oct 2024
First submitted
3 Aug 2018
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bintrafusp Alfa in people with Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, run by M.D. Anderson Cancer Center at 1 site in United States.

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 12 inclusion and 24 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: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in tumor-infiltrating lymphocytes (TIL) percentage (time frame: Baseline up to post M7824 therapy). The study lists 5 primary outcomes in all. 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 NCT03620201.

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 22 Oct 2024.

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