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NCT03789110 · ClinicalTrials.gov registry record · Phase 2

NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer

A Phase 2 study of Breast Cancer, sponsored by Dana-Farber Cancer Institute.

Active
Registry status
Phase 2
Development phase
30
Enrollment target
3
Study locations

NCT03789110: Active Phase 2 study of Breast Cancer, sponsored by Dana-Farber Cancer Institute.

NCT03789110 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 30 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03789110, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target
3
Study locations

Study Summary

This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for hypermutated HER2 negative breast cancer. The drugs involved in this study are: * Nivolumab (Opdivo ®) * Ipilimumab (Yervoy ®)

Primary Outcome

Overall Response Rate (ORR) is defined as the proportion of patients with complete or partial response evaluated by RECIST 1.1. Per RECIST 1.1: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Conditions Studied

Interventions

  • DRUG Nivolumab
  • DRUG Ipilimumab

Study Locations (3)

Massachusetts

  • Dana-Farber Cancer Institute - Boston

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Texas

  • University of Texas Southwestern Medical Center - Dallas

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2019-03-08
Est. Completion 2026-02-28
Phase Phase 2
Dana-Farber Cancer Institute

781 total trials

What the registry record for NCT03789110 still lists

NCT03789110 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Nivolumab is the first listed.

NCT03789110 reports a single indexed study location in Massachusetts, Pennsylvania, Texas.

Frequently Asked Questions

What is clinical trial NCT03789110 about?

NCT03789110 is a clinical study titled "NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer". This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for hypermutated HER2 negative breast cancer. The drugs involved in this study are: * Nivolumab (Opdivo ®) * Ipilimumab (Yervoy ®)

What is the current status of trial NCT03789110?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-03-08. Estimated completion is 2026-02-28.

What conditions does trial NCT03789110 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT03789110?

The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG).

Who is sponsoring clinical trial NCT03789110?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03789110 being conducted?

This trial has 3 study locations across Massachusetts, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03789110's enrollment target sits among peer trials

30 955th of 1224 higher than 227 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer 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 NCT03789110, the US trial registry maintained by the National Library of Medicine. NCT03789110 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.