Recruiting
Phase 1

Pembrolizumab & Cryoablation

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT06246968

Conditions

Metastatic Breast Cancer

Breast Cancer

Breast Cancer Stage IV

Triple Negative Breast Cancer

Triple Negative Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pembrolizumab

Cryoablation

Study Details

Brief summary:

Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.

Conditions

Metastatic Breast Cancer

Breast Cancer

Breast Cancer Stage IV

Triple Negative Breast Cancer

Triple Negative Breast Neoplasms

Study ID

NCT06246968

Start date

Jan 29, 2024

Status verified date

May, 2026

Completion date

Jan 29, 2027

Anticipated

Primary completion date

Jan 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients ≥ 18 years of age
  • Confirmed histologic diagnosis of metastatic 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 cryoablation 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 cryoablation. 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 cryoablation. 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 cryoablation 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 Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pembrolizumab + Cryoablation

Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (cryoablation arm): 1 (no cryoablation arm).

active comparator: Pembrolizumab

Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (cryoablation arm): 1 (no cryoablation arm).

Interventions

Pembrolizumab

Participants will receive Pembrolizumab as part of standard of care treatment.

Cryoablation

Cryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection.

Primary outcome measure

  • Change in CD4-PD1 from baseline to post-cryoablation [ Time Frame: 6 weeks after cryoablation ]

Central Contacts and Locations

Central contacts

Yolanda Bryce, MD

212-639-6530brycey@mskcc.org

Larry Norton, MD

646-888-5319nortonl@MSKCC.ORG

Locations

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

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Yolanda Bryce, MD

212-639-6530

Memorial Sloan Kettering Monmouth (Limited protocol activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Yolanda Bryce, MD

212-639-6530

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Yolanda Bryce, MD

212-639-6530

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )

Recruiting

Commack, New York, United States, 11725

Contacts

Yolanda Bryce, MD

212-639-6530

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Yolanda Bryce, MD

212-639-6530

Memorial Sloan Kettering Cancer Center (All protocol activites)

Recruiting

New York, New York, United States, 10065

Contacts

Yolanda Bryce, MD

212-639-6530

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Yolanda Bryce, MD

212-639-6530

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 20, 2026

Last verified

May, 2026

Keywords

  • metastatic TNBC
  • metastatic triple negative breast carcinoma
  • metastatic breast cancer
  • breast cancer
  • breast cancer stage IV
  • triple negative breast cancer
  • pembrolizumab
  • cryoablation
  • Memorial Sloan Kettering Cancer Center
  • 23-390
  • locally advanced breast cancer
  • locally advanced triple negative breast carcinoma
  • locally advanced triple negative breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-20.