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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase II Window of Opportunity Trial of Ipilimumab and Nivolumab in Metastatic Recurrent HER2- Inflammatory Breast Cancer (IBC) The Win Trial

Brief 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.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To determine progression free survival (PFS) in patients with newly recurrent HER2 negative inflammatory breast cancer (IBC) treated with nivolumab and ipilimumab according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.

SECONDARY OBJECTIVES:

I. To assess the overall response rate (ORR) and clinical benefit rate (CBR) according to RECIST criteria v1.1, in patients with recurrent IBC treated with nivolumab and ipilimumab.

II. To assess overall survival in patients with recurrent HER2 negative IBC treated with nivolumab and ipilimumab.

III. To assess the safety and tolerability of nivolumab and ipilimumab in patients with recurrent IBC according to the National Cancer Institute Common Terminology Criteria for Adverse Events v 4.03.

TERTIARY OBJECTIVES:

I. To assess the predictive value of baseline iSCORE and programmed cell death 1 ligand 1 (PDL-1) expression using archival tissue samples as well as any standard of care tissue obtained during study treatment.

II. To assess the predictive value of circulating cell-free tumor DNA (ctDNA) and immune signature by exosome analysis using blood samples at baseline.

OUTLINE:

Patients receive nivolumab intravenously (IV) over 30 minutes every 2 weeks (Q2W) and ipilimumab IV over 90 minutes every 6 weeks (Q6W) in the absence of disease progression or unacceptable toxicity.

After completion of st
Sponsor: Northwestern University

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

PFS in patients with newly recurrent HER2 negative IBC treated with nivolumab and ipilimumab as evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 assessed from the date of first study treatment to the date of disease progression or death from any cause, assessed up to 2 years.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
    Evaluate the ORR according to RECIST criteria v1.1 in patients with recurrent IBC treated with nivolumab and ipilimumab. Patients will have imaging scans every 8 weeks for the first 13 months and every 12 weeks thereafter, assessed up to 2 years.
  • Clinical Benefit Rate (CBR) [ Time Frame: Up to 2 years ]
    Evaluate the CBR according to RECIST criteria v1.1 in patients with recurrent IBC treated with nivolumab and ipilimumab. Patients will have imaging scans every 8 weeks for the first 13 months and every 12 weeks thereafter, assessed up to 2 years.
  • Overall survival [ Time Frame: Up to 2 years ]
    To assess overall survival in patients with recurrent HER2 negative IBC treated with nivolumab and ipilimumab, patients will be followed from the start of treatment until 2 years post-treatment or death, whichever occurs first, and average survival time will be measured.
  • Incidence of Adverse Events [ Time Frame: Up to 12 weeks after study treatment ]
    Assess the safety and tolerability of nivolumab and ipilimumab in patients with recurrent IBC by measuring the number, frequency, and severity of adverse events according to the National Cancer Institute Common Terminology Criteria Adverse events (CTCAE) v 4.03.


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: September 2, 2016
Date Started: October 2016
Date Completion:
Last Updated: September 2, 2016
Last Verified: September 2016