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

NCT05318469 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-05-06

No results posted yet for this study

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 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).

Conditions

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

Interventions

DRUG

Pembrolizumab

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

DRUG

Ivermectin

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).

DRUG

Balstilmab

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

Sponsors & Collaborators

  • Agenus Inc.

    collaborator INDUSTRY

  • Gateway for Cancer Research

    collaborator OTHER

  • Yuan Yuan

    lead OTHER

Principal Investigators

  • Yuan Yuan, MD · Cedars-Sinai Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-13
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05318469 on ClinicalTrials.gov