A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06246968
• Other study ID #: 23-390
• Status: Recruiting
• Phase: Phase 1
• Start date: January 29, 2024
• Est. completion date: January 29, 2027

Study information

• Verified date: March 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Yolanda Bryce, MD
• Phone: 212-639-6530
• Email: brycey[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 29, 2027
• Est. primary completion date: January 29, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pembrolizumab
Participants will receive Pembrolizumab as part of standard of care treatment.

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All protocol activites)	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activites)	Rockville Centre	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CD4-PD1 from baseline to post-cryoablation	Assess changes in CD4-PD1 in the blood after cryoablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).	6 weeks after cryoablation

External Links

•   Memorial Sloan Kettering Cancer Center