Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Yuan Yuan
Study ID
NCT05318469
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivermectin — DRUG
    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).
  • Balstilmab — DRUG
    Balstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle.
  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg IV on Day 1 of each 21 day cycle

Study Details

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).

Key Dates

Start date
Oct 13, 2023
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ivermectin, balstilimab)
    Patients 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

Primary Outcome Measure

Incidence of adverse events [ Time Frame: From start of study treatment until 90 days after treatment completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
[email protected]
3104232133
Yuan Yuan, MD, PhD (PRINCIPAL_INVESTIGATOR)
Monica Mita, MD (SUB_INVESTIGATOR)
Stephen Shiao, MD, PhD (SUB_INVESTIGATOR)

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By research site
Cedars-Sinai Medical Center· Los Angeles, CA

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