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Monoclonal Antibodies
Ivermectin + Balstilimab for Breast Cancer
Phase 1 & 2
Recruiting
Led By Yuan Yuan, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 2 from prior anti-cancer therapy
Patients must have progressed on 1-2 prior lines of systemic therapy (chemotherapy and/or drug-antibody conjugate) in the metastatic setting
Must not have
Known history of active TB (Mycobacterium tuberculosis)
History of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment to death or last contact. assessed up to 6 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial uses ivermectin and balstilimab to treat metastatic triple negative breast cancer. Ivermectin might stop new cancer growths, and balstilimab helps the immune system attack cancer cells. The goal is to shrink tumors and improve patient outcomes.
Who is the study for?
This trial is for adults with metastatic triple negative breast cancer who have tried 1-2 systemic therapies. They must be in good health otherwise, with a life expectancy of over 3 months and an ECOG score of ≤1. Women must not be pregnant or breastfeeding and agree to contraception. People can't join if they've had certain heart problems, severe lung conditions, active infections like Hepatitis B/C or HIV, autoimmune diseases requiring recent treatment, brain metastases unless stable without steroids for 14 days, or are on other clinical trials.
What is being tested?
The trial is testing the combination of Ivermectin and Balstilimab to see how well it works in shrinking tumors in patients with advanced breast cancer. It's a phase II study which means they're looking at effectiveness and determining the best dose while monitoring side effects closely.
What are the potential side effects?
Possible side effects include reactions related to the immune system since Balstilimab is an immunotherapy drug that may cause inflammation in various organs. Ivermectin could also lead to skin rashes or liver issues as it interferes with tumor cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have recovered from side effects of cancer treatment, except for hair loss.
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My cancer has worsened after 1-2 treatments in the metastatic stage.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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I am a woman who can have children and my pregnancy test is negative.
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I am 18 years old or older.
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I am fully active and can carry on all pre-disease activities without restriction.
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My breast cancer is triple negative, confirmed by tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active tuberculosis infection.
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I have had pneumonitis treated with steroids or currently have it.
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I do not have serious heart problems like recent heart attacks or severe heart failure.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I have received an organ or tissue transplant from another person.
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I am currently being treated for an infection.
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I have been diagnosed with HIV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of study treatment to death or last contact. assessed up to 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment to death or last contact. assessed up to 6 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Secondary study objectives
Clinical benefit rate
Duration of response
Objective response rate
+3 moreAwards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ivermectin, balstilimab)Experimental Treatment2 Interventions
Patients receive ivermectin PO QD on days 1-3, 8-10, and 15-17. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also receive balstilimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivermectin
FDA approved
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
599 Previous Clinical Trials
1,923,501 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,907 Previous Clinical Trials
41,012,103 Total Patients Enrolled
Yuan YuanLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active tuberculosis infection.I have recovered from side effects of cancer treatment, except for hair loss.You are expected to live for more than 3 months.I don't have active brain metastases and haven't needed steroids for them in the last 14 days.My cancer is PD-L1 negative for the Phase 2 trial.I have a history of Hepatitis B or active Hepatitis C.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My organs are functioning well.I have had pneumonitis treated with steroids or currently have it.I am not pregnant, not breastfeeding, and meet one of the required conditions.I am not currently on any treatments that are not allowed in this trial.My cancer has worsened after 1-2 treatments in the metastatic stage.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.I am 18 years old or older.You are expected to live for at least 3 more months.I am fully active and can carry on all pre-disease activities without restriction.I agree to have research biopsies during the study, with one additional biopsy as required.I am a woman who can have children and my pregnancy test is negative.I do not have serious heart problems like recent heart attacks or severe heart failure.I am 18 years old or older.I can read and understand English, Mandarin, Armenian, or Spanish.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have received an organ or tissue transplant from another person.I am currently being treated for an infection.I have trouble taking pills due to swallowing issues or constant nausea.I have been diagnosed with HIV.I have had cancer before, but it was either skin cancer, early-stage cancer, or I've been cancer-free for 3 years.My urine protein levels are low based on tests.I am fully active and can carry on all pre-disease activities without restriction.My breast cancer is triple negative, confirmed by tests.My cancer can be measured or evaluated by specific criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ivermectin, balstilimab)
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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