Ivonescimab in Combination With Carboplatin + Docetaxel in Early Stage Triple Negative Breast Cancer

What is the Purpose of this Study?

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called ivonescimab when combined with standard chemotherapy (carboplatin and docetaxel) before surgery for the treatment of early stage, triple-negative breast cancer (TNBC). Researchers aim to determine whether the combination of these drugs will help the body’s immune system to fight cancer, increase the length of time that patients live with cancer, and keep the cancer from worsening. Participants will receive ivonescimab in combination with standard chemotherapy intravenously (through the veins) for 6 cycles before their planned surgery. During this time, the study will keep track of how patients are responding to treatment through quality-of-life questionnaires, as well as blood, stool, and tumor samples. Ivonescimab is a special type of monoclonal antibody (protein) that works by blocking 2 specific proteins called PD-1 and VEGF-A. Blocking these proteins may activate the immune system more efficiently than the standard-of-care PD-1 inhibitor to help fight cancer cells. The U.S. Food and Drug Administration (FDA) has approved the chemotherapy drugs, carboplatin and docetaxel, as they are being used in this study.


Eligibility

Not Available


Where can I participate?

  • CS Cancer at Beverly Hills : Nikki Kem-Bernard
  • CS Cancer at Cedars-Sinai Medical Center : Nikki Kem-Bernard
  • Hunt Cancer Institute, an Affiliate of Cedars-Sinai Cancer



What is the full name of this clinical trial?

IIT2024-09-YUAN-NeoIVO: Phase II Trial of Ivonescimab in combination with carboplatin + docetaxel in Patients with Early Stage Triple Negative Breast Cancer

Study Details
Disease Type/Condition

Breast

Principal Investigator

Yuan, Yuan

Co-Investigators

Alice Chung, Amin Mirhadi, Andrew Horodner, Armando Giuliano, Catherine Dang, David Chan, Farin Amersi, Hugo Hool, Jin Sun Bitar, Justin Wayne Tiulim, Maryliza El-Masry, Philomena McAndrew, Scott Karlan, Stephen Shiao, Swati Sikaria, Syed Jilani, Thomas Lowe, Vanessa Dickey

Age Group

Adult

Phase

II

IRB Number

STUDY00003991


How do I learn more about this study?
Name

Nikki Kem-Bernard

Email
Nikki.Bernard@cshs.org
Study Detail
Disease Type/Condition

Breast

Principal Investigator

Yuan, Yuan

Age Group

Adult

Phase

II

IRB Number

IIT2024-09-YUAN-NEOIVO


Contact
Name

Nikki Kem-Bernard

Email
Nikki.Bernard@cshs.org