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

What this Trial Is About

Researchers are evaluating whether adding cryoablation to pembrolizumab treatment can improve immune response in patients with metastatic or locally advanced triple negative breast cancer. This phase 1 randomized study compares pembrolizumab alone to pembrolizumab combined with cryoablation. Participants have metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer and are randomly assigned to one of the two study groups in a 2:1 ratio favoring the cryoablation arm. Participants receive pembrolizumab as part of their standard care, administered every three weeks at a dose of 200 mg. In the experimental group, cryoablation—a minimally invasive technique that freezes tumor tissue—is performed on at least one tumor site suitable for the procedure. Eligible sites include soft tissue, liver, lung, or bone, as determined by an interventional radiologist. Treatment with pembrolizumab may be first, second, or third line therapy, and other systemic therapies may be given according to the oncologist's recommendations. During the study, participants are monitored for immune response changes, specifically the change in CD4-PD1 levels from before treatment to six weeks after cryoablation. Researchers will assess safety and feasibility of combining cryoablation with pembrolizumab. Participants undergo standard clinical evaluations and follow-ups as part of their care. The study is sponsored by Memorial Sloan Kettering Cancer Center and is expected to continue until early 2027.

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer