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

NCT02892734 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-07-16

Study results available
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Summary

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.

Conditions

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

Interventions

BIOLOGICAL

Ipilimumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Nivolumab

Given IV

Sponsors & Collaborators

Principal Investigators

  • Ricardo Costa, M.D., M.Sc. · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-18
Primary Completion
2019-02-04
Completion
2019-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02892734 on ClinicalTrials.gov