What is the Purpose of this Study?
This study focuses on people who have triple-negative breast cancer (TNBC) that has metastasized to other organs and does not qualify for immunotherapy pembrolizumab treatment. The purpose of the study is to compare the effects of an experimental immunotherapy targeting both immune checkpoint PD1 and VEGF, called pumitamig, with placebo (inactive substance) when both are given in combination with standard care chemotherapy in TNBC patients. The study aims to determine whether pumitamig can shrink the patient’s cancer or prevent it from getting worse. Additionally, researchers will evaluate the safety and tolerability of the drug, as well as whether it can help patients to live longer and how it affects quality of life. Participants will be randomly assigned to receive either pumitamig or placebo; all patients will receive chemotherapy. The chemotherapy used in this study will be either nab-paclitaxel, paclitaxel, gemcitabine plus carboplatin, or eribulin, which are approved by the U.S. Food and Drug Administration (FDA).
Eligibility
- * Are considered ineligible for combination treatment with a monospecific PD(L)1 targeting immunotherapy plus chemotherapy as per their tumor PD-L1 expression status.
- * Have confirmed locally recurrent inoperable or metastatic TNBC, or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (ER and/or progesterone receptor \[PgR\]) 1% to 10%, HER2 immunohistochemistry \[IHC\] 0, 1+, or 2+ with fluorescence in situ hybridization \[FISH\] negative for HER2 gene amplification) documented prior to trial screening as part of standard of care.
- * Have at least one measurable lesion as the targeted lesion based on RECIST v1.1.
- * Have provided a tissue sample, archival or fresh, during the screening period (bone biopsies, fine needle aspiration biopsies, and samples from pleural or peritoneal fluid are not acceptable; participants with only one target lesion are not eligible to participate in the trial).
Where can I participate?
- CS Cancer Tarzana : Nikki Kem-Bernard
- CS Cancer at Beverly Hills : Nikki Kem-Bernard
More about this Clinical Trial
What is the full name of this clinical trial?
BNT327-05: A Phase III, multisite, randomized, double-blind trial of BNT327 in combination with chemotherapy versus placebo with chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic TNBC determined ineligible for PD1 therapy based on PD-L1 negative disease