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NCT03650894 · ClinicalTrials.gov registry record · Phase 2
Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
A Phase 2 study of Breast Cancer and Breast Carcinoma, sponsored by Providence Health & Services.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT03650894: Active Phase 2 study of Breast Cancer and Breast Carcinoma, sponsored by Providence Health & Services.
NCT03650894 is a Phase 2 study of Breast Cancer and Breast Carcinoma that is active but no longer recruiting, run by Providence Health & Services. 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 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03650894, a Phase 2 study of Breast Cancer and Breast Carcinoma, is active but no longer recruiting, sponsored by Providence Health & Services.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this protocol is to evaluate the safety and efficacy of an alternative systemic combination approach that omits or delays the use of chemotherapy in metastatic disease, while improving efficacy and durability of response. The approach combines two potentially effective and previously studied strategies: androgen receptor blockade and immune checkpoint therapy.
Primary Outcome
To assess the 24-week clinical benefit rate of nivolumab combined with bicalutamide and ipilimumab in advanced HER2-negative breast cancers assessed by radiographic criteria (computed tomography (CT) scan or magnetic resonance imaging (MRI) according to iRECIST criteria.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Bicalutamide
Study Locations (2)
New York
- Memorial Sloan Kettering Cancer Center - New York
Oregon
- Providence Oncology & Hematology Care Clinic - Eastside - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-04-03 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
What the registry record for NCT03650894 still lists
NCT03650894 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 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03650894 reports a single indexed study location in New York, Oregon.
Frequently Asked Questions
What is clinical trial NCT03650894 about?
NCT03650894 is a clinical study titled "Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients". The goal of this protocol is to evaluate the safety and efficacy of an alternative systemic combination approach that omits or delays the use of chemotherapy in metastatic disease, while improving efficacy and durability of response. The approach combines two potentially effective and previously stu...
What is the current status of trial NCT03650894?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2019-04-03. Estimated completion is 2026-12.
What conditions does trial NCT03650894 study?
This clinical trial studies the following conditions: Breast Cancer, Breast Carcinoma, Breast Neoplasm Female, Breast Tumor.
What interventions are being tested in trial NCT03650894?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Bicalutamide (DRUG).
Who is sponsoring clinical trial NCT03650894?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03650894 being conducted?
This trial has 2 study locations across New York, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT03650894'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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