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

Part of paid clinical trials in New York, New York.

Sponsor
Providence Health & Services
Study ID
NCT03650894
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    Nivolumab 240 mg IV every 2 weeks
  • Ipilimumab — DRUG
    Ipilimumab 1 mg/kg IV every 6 weeks.
  • Bicalutamide — DRUG
    Oral bicalutamide 150mg (3 x 50mg tablets) daily

Study Details

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.

Key Dates

Start date
Apr 3, 2019
Status verified
Apr 2026
Primary completion
Mar 10, 2023
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab, Ipilimumab, and bicalutamide
    Participants will receive nivolumab plus ipilimumab combination therapy. Participants should receive nivolumab at a dose of 240 milligrams (mg) fixed dose as a 30-minute intravenous (IV) infusion prepared in 50 milliliter (ml) normal saline (NS) every 2 weeks until progression. Participants should receive ipilimumab at a dose of 1 mg/kilogram as a 30-minute IV infusion prepared in 50 ml NS every 6 weeks. All subjects will take bicalutamide 150mg (3 x 50mg tablets) daily.

Primary Outcome Measure

iRECIST Clinical Benefit Rate (the number of patients with objective response or ongoing stable disease at week 24 using iRECIST guidelines) [ Time Frame: 24 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Providence Oncology & Hematology Care Clinic - EastsidePortlandOregon97213-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Memorial Sloan Kettering Cancer Center· New York, NYProvidence Oncology & Hematology Care Clinic - Eastside· Portland, OR

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