Clinical Trial

Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients

Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2018-08-28; most recent amendment 2026-04-07.
Status change: Recruiting → Active, Not Recruiting 2023-05-22
Status change: Not Yet Recruiting → Recruiting 2019-04-08
Trial Details
NCT Number NCT03650894
Lead Sponsor Providence Health & Services
Collaborators: Bristol-Myers Squibb, Memorial Sloan Kettering Cancer Center
Conditions Breast Neoplasm Female, Breast Cancer, Breast Carcinoma, Breast Tumor
Enrollment 30 participants
Start Date 2019-04-03
Primary Completion 2023-03-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-13