A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03316586|
Recruitment Status : Active, not recruiting
First Posted : October 20, 2017
Last Update Posted : July 8, 2019
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)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Nivolumab Drug: Cabozantinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer|
|Actual Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2025|
Experimental: Nivolumab + Cabozantinib
Nivolumab is an experimental antibody drug that may make the immune response more active against cancer.
Other Name: Opdivo
Cabozantinib may help to shrink or stabilize breast cancer
Other Name: Cabometyx
- Overall Response Rate [ Time Frame: 2 years ]Will be defined according to RECIST 1.1
- Number of participants with adverse events [ Time Frame: 2 years ]Toxicities will be defined according to NCI CTCAE, Version 4.0
- Clinical Benefit Rate [ Time Frame: 2 years ]CBR will be determined by looking at the number of subjects who have either a complete response, partial response, or stable disease for greater than or equal to 24 weeks, per RECIST 1.1
- Progression Free Survival Rate [ Time Frame: 5 years ]PFS will be determined by using RECIST 1.1
- Overall Response Rate per Immune Criteria [ Time Frame: 2 years ]ORR will be determined according to immune-related response criteria (irRC)
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): NCT03316586
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sara Tolaney, MD||Dana-Farber Cancer Institute|