Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT02892734
Phase
PHASE2
Status
Terminated

Conditions

  • HER2/Neu Negative
  • Recurrent Inflammatory Breast Carcinoma
  • Stage IV Breast Cancer
  • Stage IV Inflammatory Breast Carcinoma

Eligibility Criteria

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

Interventions

  • Ipilimumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Nivolumab — BIOLOGICAL
    Given IV

Study Details

The purpose of this research study is to look at the efficacy (the effect on tumor) and the safety (the effect on body) of the study drugs when given as a combination in patients with metastatic recurrent epidermal growth factor receptor 2 (HER2) negative inflammatory breast cancer. This is a phase II study of 2 drugs used in combination: nivolumab and ipilimumab. The combination of these drugs is already approved by the Food and Drug Administration (FDA) to treat advanced melanoma (a type of skin cancer). Nivolumab and ipilimumab are not approved by the FDA for patients with metastatic recurrent HER2 negative inflammatory breast cancer, hence the treatment is considered experimental or investigational.

Key Dates

Start date
Sep 18, 2017
Status verified
Jun 2020
Primary completion
Feb 4, 2019
Completion
Feb 4, 2019

Study Design

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

Arms

  • Experimental: Treatment (nivolumab, ipilimumab)
    Patients receive nivolumab IV over 30 minutes Q2W and ipilimumab IV over 90 minutes Q6W in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-

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By research site
Northwestern University· Chicago, IL

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