Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-25 @ 10:05 PM
Study NCT ID:
NCT02892734
Status:
TERMINATED
Last Update Posted:
2020-07-16
First Post:
2016-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
A Phase II Window of Opportunity Trial of Ipilimumab and Nivolumab in Metastatic Recurrent HER2- Inflammatory Breast Cancer (IBC) The Win Trial
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 study treatment, patients are followed up every 4 weeks for 12 weeks, and then every 3 months for up to 2 years.
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 study treatment, patients are followed up every 4 weeks for 12 weeks, and then every 3 months for up to 2 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| STU00203191 | None | CTRP (Clinical Trial Reporting Program) | View | |
| NU 16B07 | OTHER | Northwestern University | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |
| NCI-2016-01038 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View |