Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
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|ClinicalTrials.gov Identifier: NCT03650894|
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm Female Breast Cancer Breast Carcinoma Breast Tumor||Drug: Nivolumab Drug: Ipilimumab Drug: Bicalutamide||Phase 2|
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 disease progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||138 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a phase II open-label study of nivolumab combined with ipilimumab and bicalutamide for HER2-negative metastatic or unresectable breast cancer.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Nivolumab Combined With Bicalutamide and Ipilimumab in Metastatic HER2-negative Breast Cancer|
|Actual Study Start Date :||April 3, 2019|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||April 2025|
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.
Nivolumab 240 mg IV every 2 weeks
Other Name: Opdivo
Ipilimumab 1 mg/kg IV every 6 weeks.
Other Name: Yervoy
Oral bicalutamide 150mg (3 x 50mg tablets) daily
Other Name: Casodex
- 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 ]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.
- Assess best overall objective response rate (proportion of patients who achieve a complete or partial response) [ Time Frame: 24 months ]Best overall objective response rate will be assessed by radiographic criteria from CT or MRI scans and will be based on RECIST 1.1 and iRECIST criteria
- Duration of progression free survival [ Time Frame: From first patient enrolled through last patient's progression or 24 months following last patient enrolled, whichever comes first. ]Average length of time between study entry and disease progression or death
- Overall survival rate [ Time Frame: 24 months. ]Number of patients who are alive
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650894
|Contact: Larisa Lundgren||(503) 215-2614||Larisa.Lundgren@providence.org|
|Contact: Nicole Moxon, RN||(503) 215-2619||Nicole.Moxon@providence.org|
|United States, Oregon|
|Providence Oncology & Hematology Care Clinic - Eastside||Recruiting|
|Portland, Oregon, United States, 97213|
|Sub-Investigator: Rachel Sanborn, MD|
|Sub-Investigator: Alison Conlin, MD|
|Sub-Investigator: Todd Crocenzi, MD|
|Sub-Investigator: Brendan Curti, MD|
|Sub-Investigator: John Godwin, MD|
|Sub-Investigator: Rom Leidner, MD|
|Sub-Investigator: Rui Li, MD, PhD|
|Sub-Investigator: Walter Urba, MD, PhD|
|Principal Investigator: David Page, MD|
|Sub-Investigator: Herschel Wallen, MD|
|Sub-Investigator: Moran Amy, PhD|
|Principal Investigator:||David B. Page, MD||Providence Health & Services|