A Phase 2 Study of Tobemstomig plus Nab-Paclitaxel Compared to Pembrolizumab plus Nab-Paclitaxel in People With Breast Cancer

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Full Title

A Phase II, Multicenter, Randomized Double-Blind Study of RO7247669 Combined with Nab-Paclitaxel Compared with Pembrolizumab Combined with Nab-Paclitaxel in Participants with Previously Untreated, PD-L1 Positive, Locally-Advanced Unresectable or Metastatic Triple-Negative Breast Cancer

Purpose

Researchers are comparing two different treatments for triple-negative breast cancer (TNBC). The people in this study have TNBC that is inoperable (cannot be removed with surgery) or metastasized (spread). In addition, their cancers have a protein called PD-L1.

The two treatments are tobemstomig with nab-paclitaxel or pembrolizumab with nab-paclitaxel. If you join this study, you will be randomly assigned to get one treatment or the other.

Tobemstomig is an immunotherapy drug that boosts the immune response against cancer by blocking two proteins. Pembrolizumab is also an immunotherapy medication. It takes the brakes off the immune response, allowing immune cells to find and kill cancer cells. Nab-paclitaxel is a standard chemotherapy drug for TNBC. All of these medications are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have inoperable or metastatic TNBC.
  • Have not received treatment for advanced TNBC.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Nour Abuhadra at 646-888-4451.

Protocol

24-001

Phase

Phase II (phase 2)

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT05852691