NCT03316586

A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is studying a combination of drugs as a possible treatment for metastatic triple-negative breast cancer. The drugs involved in this study are: * Cabozantinib (XL184) * Nivolumab

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has not approved the combination of Nivolumab and Cabozantinib as a treatment for any disease. The FDA has not approved Cabozantinib for this specific disease but it has been approved for other uses. The FDA (the U.S. Food and Drug Administration) has not approved nivolumab for this specific disease but it has been approved for other uses. Cabozantinib has been used in some phase I studies and information from those other research studies suggests that cabozantinib may help to shrink or stabilize breast cancer. Cancers are recognized by the immune system, and under some circumstances, the immune system may control or even eliminate tumors. An antibody is a natural protein made by the immune system that binds other proteins and molecules to fight infection and its ill effects. Antibodies stimulating the immune system have been developed for treatment of human cancers. Nivolumab is an experimental antibody drug that may make the immune response more active against cancer. In this research study, the investigators are looking at how the participant's type of breast cancer responds to the combination of cabozantinib and nivolumab.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab is an experimental antibody drug that may make the immune response more active against cancer.
DRUG	Cabozantinib	Cabozantinib may help to shrink or stabilize breast cancer

Timeline

• Start date: 2017-11-30
• Primary completion: 2019-08-30
• Completion: 2019-08-30
• First posted: 2017-10-20
• Last updated: 2021-12-28
• Results posted: 2021-12-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study