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NCT02892734 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Northwestern University.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT02892734: Clinical Trial Phase 2 study, sponsored by Northwestern University.

NCT02892734 is a Phase 2 study that was terminated before completion, run by Northwestern University. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02892734, a Phase 2 study, was terminated before completion, sponsored by Northwestern University.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2017-09-18
Est. Completion 2019-02-04
Phase Phase 2
Northwestern University

1,209 total trials

Why NCT02892734 stopped before completion

NCT02892734 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT02892734 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02892734 about?

NCT02892734 is a clinical study titled "Ipilimumab and Nivolumab in Treating Patients With Recurrent Stage IV HER2 Negative Inflammatory Breast Cancer". 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 ...

What is the current status of trial NCT02892734?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2017-09-18. Estimated completion is 2019-02-04.

What interventions are being tested in trial NCT02892734?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02892734?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02892734's enrollment target sits among peer trials

3 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02892734, the US trial registry maintained by the National Library of Medicine. NCT02892734 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.