NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03789110
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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 — DRUG
    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

Study Details

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 ®)

Key Dates

Start date
Mar 8, 2019
Status verified
Apr 2026
Primary completion
Sep 30, 2021
Completion
Feb 28, 2027

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab+Ipilimumab
    * Ipilimumab is administered intravenously every 6 weeks * Nivolumab is administered intravenously every 2 weeks

Primary Outcome Measure

Overall Response Rate of Nivolumab in Combination With Ipilimumab [ Time Frame: 2 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-
University of Texas Southwestern Medical CenterDallasTexas75390-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana-Farber Cancer Institute· Boston, MAUniversity of Pittsburgh Medical Center· Pittsburgh, PAUniversity of Texas Southwestern Medical Center· Dallas, TX

Related Studies