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A Study of Pembrolizumab and Cryoablation for Metastatic Breast Cancer

This study is looking at how well pembrolizumab, a type of immunotherapy, works when combined with cryoablation (a procedure that freezes and destroys cancer cells) for people with metastatic breast cancer, specifically triple-negative breast cancer. You would receive pembrolizumab alone or in combination with cryoablation. Researchers want to see how these treatments affect certain immune cells (CD4-PD1) in your body. To join, you must be at least 18 years old and have a confirmed diagnosis of metastatic triple-negative breast cancer with at least one tumor that can be treated with cryoablation. The study aims to enroll 30 participants, but its current recruitment status is unclear.

Study design
This interventional study will randomly assign participants to receive either pembrolizumab alone or pembrolizumab combined with cryoablation. It plans to enroll 30 participants.
What's involved
Participants will receive pembrolizumab as part of standard care. Cryoablation is a minimally invasive procedure that may be performed.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes in CD4-PD1 levels at 6 weeks after cryoablation.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06246968

A Study of Pembrolizumab and Ablation (Cryoablation or Histotripsy) in People With Breast Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Memorial Sloan Kettering Cancer Center
~30 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:PembrolizumabCryoablationHistotripsy

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in CD4-PD1 from baseline to post-ablation
Measured over 6 weeks after cryoablation

Conditions

Metastatic Breast Cancer
Breast Cancer
Breast Cancer Stage IV
Triple Negative Breast Cancer
Triple Negative Breast Neoplasms
Metastatic Triple-Negative Breast Carcinoma
Locally Advanced Breast Cancer
Locally Advanced Triple-Negative Breast Carcinoma

Explore related trials

Triple-negative breast cancer

NCT06246968

Where you'd take part

This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center (All protocol activites)

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)

    Basking Ridge, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Monmouth (Limited protocol activities)

    Middletown, New Jerseystudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Nassau (Limited Protocol Activites)

    Rockville Centre, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

    Commack, New Yorkstudy coordinator listed

    Recruiting

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Yolanda Bryce, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

Who to contact

Yolanda Bryce, MD
[email protected]
212-639-6530
Email the study team

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Eligibility criteria

Inclusion

Patients ≥ 18 years of age
Confirmed histologic diagnosis of metastatic TNBC or locally advanced inoperable TNBC
1 site amenable cryoablation of at least 1.5 cm in size as determined by an Interventional Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an Interventional Radiologist to be safest and most feasible.
Physically fit (clinically eligible) to undergo ablation as per usual clinical practice
Per clinical guidelines, women of childbearing age should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of the drug, which will be assessed and monitored by, and the responsibility of, the patient's medical oncologist (not study investigators or research team) as pembrolizumab is standard of care. Memorial Sloan Kettering Cancer Center Pregnancy Standards will be followed prior to ablation. That is, female patients that are 11-50 years of age and of childbearing potential will undergo a pregnancy test within 2 weeks (15 days) before ablation. Pregnancy test will not be required in patients with bilateral oophorectomy, bilateral salpingectomy, bilateral salpingectomy-oophorectomy, hysterectomy, menopause (no menses ≥ 1 year prior to treatment or after completion of all treatment), or surgical sterilization (i.e. tubal ligation or blockage), with documentation of permanent exemptions in CIS ("Pregnancy Testing Exemption").
Pembrolizumab therapy (200 mg every 3 weeks) planned as part of standard of care as first, second, or third line of therapy
Eligible for PD-1 inhibitor per the patient's medical oncologist, with planned treatment with PD-1 inhibitor per the patient's medical oncologist. Additional systemic therapy is per the patient's medical oncologist. The following systemic therapy will be accepted (the timing of the systemic therapy relative to pembrolizumab and ablation is not restricted):
Capecitabine (Xeloda, available as a generic drug)
Carboplatin (Paraplatin, available as a generic drug)
Cisplatin (Platinol, available as a generic drug)
Cyclophosphamide (Cytoxan, available as a generic drug)
Docetaxel (Taxotere)
Doxorubicin (Adriamycin, available as a generic drug)
Pegylated liposomal doxorubicin (Doxil)
Epirubicin (Ellence, available as a generic drug)
Eribulin (Halaven)
Fluorouracil (5-FU, Adrucil, available as a generic drug)
Gemcitabine (Gemzar, available as a generic drug)
Ixabepilone (Ixempra)
Methotrexate (available as a general drug)
Nab-paclitaxel (Abraxane)
Paclitaxel (Taxol, available as a generic drug)
Vinorelbine (Navelbine, available as a generic drug)

Exclusion

Patient not eligible for PD-1 inhibitor per the patient's medical oncologist
No disease amenable for ablation
Pembrolizumab therapy not planned as part of standard of care

What this trial measures

  • Change in CD4-PD1 from baseline to post-ablation6 weeks after cryoablation

    Assess changes in CD4-PD1 in the blood after ablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).