RecruitingPhase 1NCT06246968

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

30 participants

Start Date

Jan 29, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study combines pembrolizumab (an immunotherapy) with cryoablation — a procedure where a tumor is frozen and destroyed with extreme cold — in people with metastatic triple-negative breast cancer (TNBC). The idea is that destroying one tumor with freezing releases signals that may help the immune system attack other cancer sites in the body. **You may be eligible if...** - You are 18 or older - You have confirmed metastatic triple-negative breast cancer (a type that is estrogen receptor-negative, progesterone receptor-negative, and HER2-negative) - You have at least one tumor site that can be safely targeted by cryoablation (at least 1.5 cm in size) - An interventional radiologist has confirmed the procedure is feasible for you - You are physically fit to undergo the cryoablation procedure - Women of childbearing age must use effective contraception during and after treatment **You may NOT be eligible if...** - You have received prior treatment with pembrolizumab or similar checkpoint immunotherapy drugs - No tumor site is accessible or large enough for cryoablation - You have active autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

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

DEVICECryoablation

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


Locations(7)

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

Basking Ridge, New Jersey, 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 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 Cancer Center (All protocol activites)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06246968


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