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
This is a phase II trial to assess the clinical efficacy and safety of nivolumab
(anti-Programmed Death receptor-1, or anti-PD-1) combined with bicalutamide (Androgen
Receptor (AR) inhibitor) and ipilimumab (anti-cytotoxic T-lymphocyte-associated protein 4, or
anit-CTLA4) in patients with advanced breast cancer.
This study will include adult women with metastatic or locally advanced unresectable Human
Epidermal Growth Factor (HER2)-negative breast cancer (by National Comprehensive Cancer
Network (NCCN) criteria). Triple-negative breast cancer tumors will require confirmation of
AR positivity at screening. Participants will have had no more than one line of previous
chemotherapy in non-curative setting; subjects with metastatic progression within 1 year
following completion of curative-intent chemotherapy are eligible if they have not received
any additional lines of systemic therapy in the non-curative setting.
Women who meet all of the study inclusion criteria, none of the study exclusion criteria, and
agree to participate will receive a combination of the following:
Intravenous nivolumab 240mg, every 2 weeks until progression or unacceptable toxicity
Intravenous ipilimumab 1mg/kg, every 6 weeks until progression or unacceptable toxicity
Oral bicalutamide 150mg, daily until progression or unacceptable toxicity
Participants are to be treated for up to 24 months. Patients who have ongoing response will
discontinue ipilimumab and nivolumab after 24 months, but at the discretion of the
investigator may continue bicalutamide, and will continue assessments as per standard of
care. Any patient who subsequently progresses will have the option to resume treatment upon
Ductal Carcinoma In Situ,
Breast Cancer Diagnosis,
Breast Neoplasm Female,
Ductal Carcinoma In Situ (DCIS),
tumor of the breast,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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