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NCT05318469 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, sponsored by Yuan Yuan.

Recruiting
Registry status
Phase 1
Development phase
34
Enrollment target
1
Study location

NCT05318469: Recruiting Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, sponsored by Yuan Yuan.

NCT05318469 is a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma that is actively recruiting participants, run by Yuan Yuan. The registered enrollment target is 34 participants, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05318469, a Phase 1 study of Anatomic Stage IV Breast Cancer AJCC v8 and Metastatic Triple-Negative Breast Carcinoma, is actively recruiting participants, sponsored by Yuan Yuan.

RECRUITING
Registry status
Phase 1
Development phase
34 participants
Enrollment target
1
Study location

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).

Primary Outcome

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

Conditions Studied

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

Interventions

  • DRUG Pembrolizumab
  • DRUG Ivermectin
  • DRUG Balstilmab

Study Locations (1)

California

  • Cedars-Sinai Medical Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2023-10-13
Est. Completion 2026-10
Phase Phase 1
Yuan Yuan

3 total trials

What NCT05318469 shows while recruiting

NCT05318469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 166-participant average among 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials with a reported enrollment target (80% lower).

The record links to 2 conditions, with Anatomic Stage IV Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT05318469 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT05318469 about?

NCT05318469 is a clinical study titled "Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative 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 that has spread to other places in the body (metastatic). Immunotherapy with...

What is the current status of trial NCT05318469?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2023-10-13. Estimated completion is 2026-10.

What conditions does trial NCT05318469 study?

This clinical trial studies the following conditions: Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma.

What interventions are being tested in trial NCT05318469?

The interventions under investigation include: Pembrolizumab (DRUG), Ivermectin (DRUG), Balstilmab (DRUG).

Who is sponsoring clinical trial NCT05318469?

This trial is sponsored by Yuan Yuan, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05318469 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Anatomic Stage IV Breast Cancer AJCC v8

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05318469's enrollment target sits among peer trials

34 36th of 59 higher than 24 of 59 other Anatomic Stage IV Breast Cancer AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anatomic Stage IV Breast Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05318469

Source: ClinicalTrials.gov NCT05318469, the US trial registry maintained by the National Library of Medicine. NCT05318469 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.