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Anatomic Stage IV Breast Cancer AJCC v8Phase 1/2NCT05318469

Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer and HR+/HER2- Metastatic Breast Cancer

A Phase 1/2 study testing Ivermectin, Balstilmab and Pembrolizumab in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, run by Yuan Yuan at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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 and HR+/HER2- metastatic breast cancer that has spread to other places in the body… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ivermectin, Balstilmab and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
13 Oct 2023to Oct 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) ≤ 1
  • Life expectancy > 3 months
  • At least one biopsy proven Triple Negative Breast Cancer (TNBC) or HR+/HER2- breast cancer in the metastatic setting. TNBC is defined by ER and PR ≤ 10% and HER2 negative (by IHC or FISH), per ASCO/CAP guidelines. In the case of discordant expression results, eligibility must be discussed and determined at the discretion of the study PI.
  • Patients must have progressed on 1-2 prior lines of systemic therapy (chemotherapy and/or drug-antibody conjugate) in the metastatic setting
  • Measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
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  • Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 2 from prior anti-cancer therapy
  • Patients must have adequate organ function as defined in the following:
  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3
  • Platelets ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks
  • Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN
  • Aspartate aminotransferase (AST) ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases
  • Alanine aminotransferase (ALT) ≤ 1.5 x ULN or ≤ 3 x ULN with liver metastases
  • Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 30 mL/min for participant with creatinine levels >1.5 x institutional ULN
  • International normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
  • Women of childbearing potential (WOCBP): negative urine or serum pregnancy test * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP) OR
  • Females of child-bearing potential must be willing to use effective contraception during study and for 120 days after the last dose
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Who cannot join

  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
  • Prohibited Treatments and/or Therapies:
  • Chemotherapy, radiation therapy, biological therapy, immunotherapy within 28 days prior to day 1 of protocol therapy
  • Prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
  • Any live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
  • Participants on any dose of warfarin. Use of low molecular weight heparin, antithrombin agents, anti-platelet agents or factor Xa inhibitors is allowed
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  • Participants may not be currently participating in or participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
  • Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting during screening)
  • Women who are or are planning to become pregnant or breastfeed
  • Known allergy to any of the components within the study agents and/or their excipients
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least three years
  • Participants must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention
  • History of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Active infection requiring systemic therapy
  • Known history of Human Immunodeficiency Virus (HIV) infection
  • Known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority
  • Known history of active TB (Mycobacterium tuberculosis)
  • Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g., recovery from major surgery, completion of treatment for severe infection).
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
  • Has had an allogenic tissue/solid organ transplant
  • Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at screening
  • Subjects having > 1+ proteinuria on urine dipstick testing unless a 24-hour urine collection for quantitative assessment indicates that the urine protein is < 1 g/24 hours
  • Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Navigator contact

310-423-5842

GroupCancerTrialInformation@cshs.org

United States1 site, 1 recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org

    Yuan Yuan, MD, PhD

    Recruiting

Other trials in United States

About this study

Official title: A Phase I/II Study Evaluating the Safety and Efficacy of Ivermectin in Combination With Immune Checkpoint Inhibitor in Patients With Metastatic Triple Negative Breast Cancer and HR+/HER2- Metastatic Breast Cancer

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 and HR+/HER2- metastatic 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 and HR+/HER2- metastatic 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).

Read the detailed description

Patients receive ivermectin orally (PO) once daily (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 or pembrolizumab intravenously (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.

After completion of study treatment, patients are followed up for 90 days and then periodically thereafter.

Being tested
Ivermectin, Balstilmab, Pembrolizumab
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IvermectinDrug

    Also called Sklice, Stromectol

    Ivermectin at the assigned dose administered PO on Days 1-3, 8-10, 15-17 of each 21 day cycle (Days1-3 of each week).

  • BalstilmabDrug

    Balstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle.

  • PembrolizumabDrug

    Pembrolizumab 200 mg IV on Day 1 of each 21 day cycle

Study groups in NCT05318469
Study groupRoleWhat they receive
Treatment (ivermectin, balstilimab)ExperimentalPatients will receive balstilimab 450 mg or pembrolizumab 200 mg, IV, on Day 1 of each 3 week cycle and ivermectin at the assigned dose (see Section 5.1, Table 5.1.2), PO, Days 1-3, 8-10, 15-17 of each cycle (Days 1-3 of each week) until disease progression, intolerable toxicities, withdrawal of consent, or up to 35 treatments or 2 years of balstilimab or pembrolizumab, whichever comes first
Receives: Drug: Ivermectin; Drug: Balstilmab; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Phase 1: To determine the recommended phase 2 dose of ivermectin in combination with balstilimab or pembrolizumab using NCI-CTCAE v5.0

    Measured: From start of study treatment until 90 days after treatment completion

  2. Objective response rate

    Phase 2: To determine the efficacy of ivermectin in combination with balstilimab or pembrolizumab in mTNBC and HR+/HER2- MBC using the objective response rate (ORR)

    Measured: From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 2 years.

Secondary outcomes (6)

  1. Objective response rate

    Evaluate the efficacy of ivermectin in combination with balstilimab or pembrolizumab in mTNBC or HR+/HER2- MBC using objective response rate (ORR) using RECIST 1.1

    Measured: From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 2 years.

  2. Progression free survival

    From start of therapy until first documentation of disease progression per RECIST 1.1 or death due to any cause.

    Measured: From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 6 years.

  3. Overall survival

    From start of study treatment to date of death due to any cause. Patient's last known to be alive are censored at date of last contact.

    Measured: From start of study treatment to death or last contact. Assessed up to 6 years

  4. Duration of response

    Measured from the date of first objective response recorded (CR or PR) until progression per RECIST 1.1, death or last contact (censored). Patient's last known to be alive are censored at date of last contact.

    Measured: From the date of first objective response recorded until disease progression, death or last contact. Assessed up to 6 years

  5. Clinical benefit rate

    Defined as progression-free for at least 6 months or CR or PR per RECIST 1.1.

    Measured: From start of study treatment until disease progression, intolerable toxicities, or withdrawal of consent. Assessed up to 6 years.

  6. Patients' quality of life

    Evaluated by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) version 3.0 per standardized EORTC scoring guidelines.

    Measured: On day 1 of each 3 week cycle and at end of treatment visit. Assessed up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start13 Oct 2023
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05318469
Sponsor's protocol ID
IIT2022-07-YUAN-IB-TNBC
Status last verified
Oct 2026
First submitted
1 Apr 2022
Last updated
30 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ivermectin, Balstilmab and Pembrolizumab in people with Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, run by Yuan Yuan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: From start of study treatment until 90 days after treatment completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05318469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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