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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
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
Study Summary
This trial is testing ivermectin with pembrolizumab for triple negative breast cancer that has spread. They want to find the best dose and check for side effects.
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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Secondary outcome measures
Clinical benefit rate
Duration of response
Objective response rate
+3 moreTrial 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
567 Previous Clinical Trials
1,922,619 Total Patients Enrolled
43 Trials studying Breast Cancer
6,649 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,813 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Yuan YuanLead Sponsor
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the risks associated with Pembrolizumab?
"Pembrolizumab falls into the Phase 2 category, meaning that while there is evidence suggesting it is safe, none of the data collected points to the medication being effective."
Answered by AI
Are people still being recruited for this clinical trial?
"As indicated by this website, the trial is not currently looking for more participants. This particular study was posted on September 10th of last year and edited most recently on July 26th, 2022. There are 2439 other trials which are actively recruiting patients right now."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
California
How old are they?
18 - 65
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
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