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Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer

NCT03546686 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-03-27

No results posted yet for this study

Summary

The purpose of this study is to determine the impact of pre-operative cryoablation, and immune checkpoint inhibition (ICI) on on 3-year Event Free Survival (EFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuvant chemotherapy.

Conditions

Interventions

DRUG

Pembrolizumab

Pembro will be administered 1-20 days before the cryoablation date per SOC and q3 weeks after surgery for 9 cycles per SOC.

PROCEDURE

Core Biopsy/Cryoablation

US-guided core biopsy and cryoablation 7-10 days prior to surgery.

PROCEDURE

Breast Surgery

Standard-of-care definitive surgery.

DRUG

Ipilimumab

ipilimumab 1mg/Kg IV is administered 1-5 days prior to cryoablation.

DRUG

Nivolumab

nivolumab 240mg IV flat dose is administered 1-5 days prior to cryoablation and 240mg IV every 2 weeks ± 3 days starting 3 (+/-1) weeks after surgery.

Sponsors & Collaborators

Principal Investigators

  • Heather McArthur, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2026-06-30
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03546686 on ClinicalTrials.gov