drugset / Trial / NCT03650894
Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
Phase 2
Active not recruiting
30 enrolled
Providence Health & Services
Bristol-Myers Squibb · collabMemorial Sloan Kettering Cancer Center · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-04-03
- Primary completion
- 2023-03-10
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bicalutamide | Other / unclassified | 150 mg | Oral |
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 240 mg | Intravenous |