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Checkpoint Inhibitor

Pembrolizumab + Cryoablation for Breast Cancer

Phase 1

Recruiting

Led By Yolanda Bryce, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Confirmed histologic diagnosis of metastatic TNBC

Pembrolizumab therapy (200 mg every 3 weeks) planned as part of standard of care as first, second, or third line of therapy

Must not have

Pembrolizumab therapy not planned as part of standard of care

No disease amenable for cryoablation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after cryoablation

Awards & highlights

No Placebo-Only Group

Summary

"This trial will involve patients with advanced breast cancer who will receive either pembrolizumab with cryoablation or pembrolizumab alone. The treatment assignment will be random."

Who is the study for?

This trial is for individuals with metastatic breast cancer. Participants will be randomly assigned to receive either a combination of pembrolizumab and cryoablation or just pembrolizumab.

What is being tested?

The study is testing the effectiveness of combining pembrolizumab, an immunotherapy drug, with cryoablation—a procedure that freezes cancer cells—compared to using pembrolizumab alone in treating metastatic breast cancer.

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects such as fatigue, skin reactions, or inflammation of organs. Cryoablation can lead to pain at the treatment site, bruising, and potentially damage nearby tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is triple-negative and has spread.

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I am planned to receive Pembrolizumab as an initial treatment.

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I am 18 years old or older.

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I have a tumor suitable for freezing treatment, as confirmed by a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not planned to receive Pembrolizumab as a standard treatment.

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My condition cannot be treated with cryoablation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks after cryoablation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks after cryoablation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks after cryoablation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in CD4-PD1 from baseline to post-cryoablation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pembrolizumab + CryoablationExperimental Treatment2 Interventions

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).

Group II: PembrolizumabActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cryoablation

2017

Completed Phase 2

~1030

Pembrolizumab

2017

Completed Phase 3