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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03316586
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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

Key Dates

Start date
Nov 30, 2017
Status verified
Nov 2021
Primary completion
Aug 30, 2019
Completion
Aug 30, 2019

Study Design

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

Arms

  • Experimental: Nivolumab + Cabozantinib
    * Nivolumab was administered every 28 days at a dose of 480mg given intravenously over 30 minutes (+/- 10 minutes) using a volumetric pump with 0.2 to 1.2 micron pore size, low protein binding polyethersulfone membrane in-line filter * Cabozantinib was administered orally, once daily for 28 days at a dose of 40 mg.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-

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