M7824 (Anti-PD-L1/TGF-Beta TRAP) in a Window Setting in Patients With Stage II-III HER2/Neu Positive (HER2+) Breast Cancer (BC)
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|ClinicalTrials.gov Identifier: NCT03620201|
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : January 9, 2019
The goal of this clinical research study is to learn if giving M7824 (MSB0011359C) to patients with Stage II or III HER2+ breast cancer who are scheduled to receive chemotherapy and have surgery as part of their standard care can change how many tumor-infiltrating lymphocytes (TILs) are near the tumor. TILs are a type of white blood cell that is related to your immune system.
The safety and tolerability of M7824 will also be studied.
This is an investigational study. M7824 is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work.
Up to 20 participants will be enrolled at MD Anderson. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Breast||Drug: M7824 - patients with Stage II or III HER2+ breast cancer Drug: Chemotherapy||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||August 3, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Participants receive M7824 by vein over 1 hour on Days 1 and 15 of the study.
Drug: M7824 - patients with Stage II or III HER2+ breast cancer
M7824 1200 mg administered by vein for a total of 2 doses given once every 2 weeks to patients with stage II-III HER2+ breast cancer. The first dose given within 7 days after the pretreatment biopsy. The second dose of M7824 given 14 days days after the first dose.
Other Name: MSB0011359C
After participant's last dose of M7824, participant will receive chemotherapy during Days 28-56. Study doctor decides what type of chemotherapy to be given.
- change in tumor-infiltrating lymphocytes (TIL) percentage pre and post M7824 therapy [ Time Frame: Assessed using core biopsy tissue obtained prior to dose 1 of study drug and repeat biopsy obtained 2 weeks after dose 2 of study drug ]
- Adverse Events (AE) with M7824 Therapy [ Time Frame: Start of M7824 therapy up to 90 days after last dose ]
AE is any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product, regardless of causal relationship with this treatment.
AE determined by the NCI-CTCAE v4.03.
- Pathological Response with M7824 Therapy [ Time Frame: 56 days after completing chemotherapy at surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620201
|Contact: Jennifer Litton, MDemail@example.com|
|United States, Texas|
|MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Jennifer Litton, MD||M.D. Anderson Cancer Center|