NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer
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ClinicalTrials.gov Identifier: NCT03789110 |
Recruitment Status :
Active, not recruiting
First Posted : December 28, 2018
Results First Posted : September 27, 2022
Last Update Posted : December 13, 2023
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | December 26, 2018 | ||||||||||||
First Posted Date ICMJE | December 28, 2018 | ||||||||||||
Results First Submitted Date ICMJE | August 30, 2022 | ||||||||||||
Results First Posted Date ICMJE | September 27, 2022 | ||||||||||||
Last Update Posted Date | December 13, 2023 | ||||||||||||
Actual Study Start Date ICMJE | March 8, 2019 | ||||||||||||
Actual Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Overall Response Rate of Nivolumab in Combination With Ipilimumab [ Time Frame: 2 years ] Overall Response Rate (ORR) is defined as the proportion of patients with complete or partial response evaluated by RECIST 1.1. Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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Original Primary Outcome Measures ICMJE |
Overall Response Rate of nivolumab in combination with ipilimumab [ Time Frame: 2 years ] | ||||||||||||
Change History | |||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer | ||||||||||||
Official Title ICMJE | NIMBUS: A Phase II Study of Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer | ||||||||||||
Brief Summary | 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:
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Detailed Description | 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 |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | ||||||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Nivolumab+Ipilimumab
Interventions:
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Publications * | Not Provided | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
Actual Enrollment ICMJE |
30 | ||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||
Estimated Study Completion Date ICMJE | June 19, 2024 | ||||||||||||
Actual Primary Completion Date | September 30, 2021 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT03789110 | ||||||||||||
Other Study ID Numbers ICMJE | 18-561 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Sara Tolaney, MD, Dana-Farber Cancer Institute | ||||||||||||
Original Responsible Party | Sara Tolaney, Dana-Farber Cancer Institute, Primary Investigator | ||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||
Collaborators ICMJE | Bristol-Myers Squibb | ||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||
Verification Date | December 2023 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |