Combining pembrolizumab with cryoablation for metastatic breast cancer
Does Cryoablation Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?
This study is testing if combining a drug called pembrolizumab with a freezing treatment can help people with advanced triple negative breast cancer feel better compared to just using the drug alone.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | pembrolizumab, Methotrexate, Cyclophosphamide, Doxorubicin, Cytoxan |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT06246968 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of pembrolizumab, an immunotherapy drug, in combination with cryoablation, a localized treatment that freezes cancer cells, in patients with metastatic triple negative breast cancer (TNBC). Participants will be randomly assigned to receive either the combination treatment or pembrolizumab alone. The goal is to evaluate the safety and efficacy of this approach in managing advanced breast cancer. Eligible patients must have a confirmed diagnosis of metastatic TNBC and a suitable site for cryoablation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of metastatic triple negative breast cancer and a suitable site for cryoablation.
Not a fit: Patients with non-metastatic breast cancer or those who do not have a suitable site for cryoablation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced metastatic breast cancer.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy and localized treatment combinations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All protocol activites) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activites) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Yolanda Bryce, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Yolanda Bryce, MD
- Email: brycey@mskcc.org
- Phone: 212-639-6530
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.