M7824 and Eribulin Mesylate in Treating Participants With Metastatic Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03579472|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : October 8, 2018
The goal of this clinical research study is to find the highest tolerable dose of M7824 (MSB0011359C) that can be given with eribulin to patients with triple negative breast cancer (TNBC) that is metastatic (has spread). The safety of this drug combination 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. Eribulin is FDA approved and commercially available for the treatment of breast cancer. The study doctor can explain how the study drugs are 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|
|Anatomic Stage IV Breast Cancer AJCC v8 Estrogen Receptor Negative HER2/Neu Negative Progesterone Receptor Negative Prognostic Stage IV Breast Cancer AJCC v8 Triple-Negative Breast Carcinoma||Drug: Anti-PD-L1/TGFbetaRII Fusion Protein M7824 Drug: Eribulin Mesylate||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase Ib Trial of M7824 and Eribulin in Patients With Metastatic Triple Negative Breast Cancer (TNBC)|
|Actual Study Start Date :||May 30, 2018|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
Experimental: Treatment (M7824, eribulin mesylate)
Participants receive anti-PD-L1/TGFbetaRII fusion protein M7824 IV over 50-80 minutes on days 1, 15, and 29, and eribulin mesylate IV over 2-5 minutes on days 1, 8, 22, and 29. Treatment repeats every 42 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Drug: Anti-PD-L1/TGFbetaRII Fusion Protein M7824
Drug: Eribulin Mesylate
- Recommended phase II dose (RP2D) defined as highest dose with dose limiting toxicity (DLT) rate =< 30% [ Time Frame: Up to 90 days post-treatment ]
- Incidence of adverse events (AE) [ Time Frame: Up to 90 days post-treatment ]AEs tabulated using frequencies and percentages, by severity, by grade, and by relationship to study treatment.
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): NCT03579472
|Contact: Jennifer K. Littonemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jennifer K. Litton 713-792-2817 firstname.lastname@example.org|
|Principal Investigator: Jennifer K. Litton|
|Principal Investigator:||Jennifer Litton||M.D. Anderson Cancer Center|