Actively Recruiting
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
Led by Yuan Yuan · Updated on 2026-05-06
34
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
Sponsors
Y
Yuan Yuan
Lead Sponsor
A
Agenus Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the side effects and best dose of ivermectin in combination with balstilimab or pembrolizumab and to see how well they they work in shrinking tumors in patients with triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as balstilimab or pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ivermectin may help block the formation of growths that may become cancer. Giving ivermectin with balstilimab or pembrolizumab may increase the effect of balstilimab or pembrolizumab in shrinking tumors in patients with triple negative breast cancer. The secondary objectives of the study include evaluating the following efficacy outcomes: objective response rate (ORR), progression free survival (PFS), overall survival (OS), duration of response (DOR), clinical benefit rate (CBR), and patients' quality of life (QOL) by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).
CONDITIONS
Official Title
Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy greater than 3 months
- Confirmed metastatic triple negative breast cancer by standard tests
- Progressed on 1-2 prior lines of systemic therapy for metastatic disease
- Measurable or evaluable disease by RECIST 1.1 criteria
- Fully recovered from acute toxic effects (except hair loss) of prior cancer therapy to grade 2 or less
- For Phase 2, must be PD-L1 negative; Phase 1 allows any PD-L1 status
- Adequate organ function as defined by blood counts, liver and kidney tests, and heart function
- Negative pregnancy test for women of childbearing potential
- Males must agree to use contraception during treatment and for 120 days after
- Females not pregnant or breastfeeding and agree to use effective contraception if of childbearing potential
- Ability to give informed consent and comply with study requirements
You will not qualify if you...
- Immunodeficiency or recent use of systemic steroids or immunosuppressive therapy within 7 days before study drug
- Chemotherapy, radiation, biological therapy, or immunotherapy within 28 days before study start
- Prior immune checkpoint inhibitor therapy in metastatic setting unless last dose was at least 1 year ago in neoadjuvant/adjuvant setting
- Radiotherapy within 2 weeks before study start unless palliative with 1 week washout
- Live vaccine within 30 days before study drug
- Use of warfarin; low molecular weight heparin and other anticoagulants allowed
- Participation in another investigational study within 4 weeks before study drug
- Issues tolerating oral medication
- Pregnant or planning pregnancy or breastfeeding
- Allergy to study drug components
- Other prior malignancy except certain treated cancers in remission
- Active or unstable brain metastases or carcinomatous meningitis
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV, active Hepatitis B or C, or active tuberculosis
- Medical conditions increasing risk as judged by investigator
- Psychiatric or substance abuse disorders interfering with study compliance
- Significant cardiovascular disease or recent cardiac events
- Significant proteinuria unless quantitatively low
- Active autoimmune disease requiring systemic treatment in past 2 years
- History of allogenic tissue or organ transplant
- Any other condition that contraindicates study participation due to safety concerns
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
C
Clinical Trial Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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