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M7824 in Treating Patients With Stage II-III HER2 Positive Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT03620201•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Detailed Description

PRIMARY OBJECTIVE: I. To evaluate the change in tumor-infiltrating lymphocytes (TIL) percentage pre and post M7824 therapy. SECONDARY OBJECTIVES: I. 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: I. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)
•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
+2 more criteria

Exclusion Criteria

•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
•* 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
+14 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

August 3, 2018

Primary Completion Date

October 18, 2024

Completion Date

October 18, 2024

Last Updated

October 22, 2024

Enrollment

ACTUAL participants

Conditions

Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8

Interventions

Bintrafusp Alfa

DRUG

Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy

NCT06401889

Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8+5 more

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RECRUITINGPHASE1

An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial

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Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy

An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial

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