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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study treatment to death or last contact. assessed up to 6 years for reporting.

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 more

Awards & 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

0 / 15Eligibility criteria met