NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03789110|
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : November 7, 2019
This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for hypermutated HER2 negative breast cancer.
The drugs involved in this study are:
- Nivolumab (Opdivo ®)
- Ipilimumab (Yervoy ®)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Nivolumab Drug: Ipilimumab||Phase 2|
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied.
Nivolumab is called an anti- PD-1 or a checkpoint inhibitor and is an antibody (a type of human protein) designed to allow the body's own immune system to destroy tumors. Ipilimumab is called an anti-CTLA-4 and is a type of antibody that works to prevent your body's immune system from stopping to fight this specific cancer.
The U.S. Food and Drug Administration (FDA) has not approved nivolumab for this specific disease but it has been approved for other uses including but not limited to non-small cell lung cancer, melanoma and renal cell carcinoma.
The U.S. Food and Drug Administration (FDA) has not approved ipilimumab for this specific disease but it has been approved for other uses such as melanoma and renal cell carcinoma.
The combination of nivolumab with ipilimumab may or may not increase anti-cancer activity by further boosting the immune system. At this time, the FDA has not approved nivolumab in combination with ipilimumab for this specific disease although these drugs have been approved for other uses such as melanoma and renal cell carcinoma.
The purpose of this research study is to determine how nivolumab together with ipilimumab, works in treating breast cancer that has spread to other parts of the body. The investigators are also investigating whether there are certain DNA or protein markers in the blood or tumor tissue that may indicate whether the combination will work in future patients
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NIMBUS: A Phase II Study of Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer|
|Actual Study Start Date :||March 8, 2019|
|Estimated Primary Completion Date :||April 19, 2022|
|Estimated Study Completion Date :||October 19, 2022|
Nivolumab is called an anti- PD-1 or a checkpoint inhibitor and is an antibody (a type of human protein) designed to allow the body's own immune system to destroy tumors
Other Name: Opdivo
Ipilimumab is called an anti-CTLA-4 and is a type of antibody that works to prevent the body's immune system from stopping to fight a specific cancer
Other Name: Yervoy
- Overall Response Rate of nivolumab in combination with ipilimumab [ Time Frame: 2 years ]
- Overall Response Rate of the combination according to immune-related response criteria [ Time Frame: 2 years ]
- Clinical Benefit Rate [ Time Frame: 2 Years ]
- Progression Free Survival [ Time Frame: 2 years ]
- Overall Survival [ Time Frame: 2 years ]
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): NCT03789110
|Contact: Sara Tolaney, MD, MPH||617-632-3800||STOLANEY@PARTNERS.ORG|
|United States, Massachusetts|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Sara Tolaney, MD, MPH 617-632-3548 STOLANEY@PARTNERS.ORG|
|Principal Investigator: Sara Tolaney|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Sangeetha Reddy, MD Sangeetha.Reddy@UTSouthwestern.edu|
|Principal Investigator:||Sara Tolaney, MD, MPH||Dana-Farber Cancer Institute|