M7824 and Eribulin Mesylate in Treating Patients 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 : May 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anatomic Stage IV Breast Cancer AJCC v8 Estrogen Receptor Negative HER2/Neu Negative Metastatic Triple-Negative Breast Carcinoma Progesterone Receptor Negative Prognostic Stage IV Breast Cancer AJCC v8||Drug: Anti-PD-L1/TGFbetaRII Fusion Protein M7824 Drug: Eribulin Mesylate||Phase 1|
I. To determine the recommended phase II dose (RP2D) of eribulin mesylate (eribulin) when in combination with the fixed dose of M7824 in patients with metastatic triple-negative breast cancer (TNBC).
II. To evaluate the safety and tolerability of M7824 when in combination with eribulin in patients with metastatic TNBC.
I. To determine the best overall response (BOR) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
II. To determine the overall response rate (ORR).
I. Estimation of progression-free survival (PFS) in metastatic TNBC patients treated with M7824 in combination with eribulin.
II. To assess immunologic/molecular responses to M7824 in combination with eribulin in patients with metastatic TNBC, by performing correlative studies on tissue samples to evaluate systemic and tumor biomarkers of response and resistance to M7824 and eribulin.
Patients receive anti-PD-L1/TGFbetaRII fusion protein M7824 intravenously (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.
After completion of study treatment, patients are followed up at 90 days.
|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, 2021|
|Estimated Study Completion Date :||October 31, 2021|
Experimental: Treatment (M7824, eribulin mesylate)
Patients 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. Littonfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jennifer K. Litton 713-792-2817|
|Principal Investigator: Jennifer K. Litton|
|Principal Investigator:||Jennifer K Litton||M.D. Anderson Cancer Center|