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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks after cryoablation

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in CD4-PD1 from baseline to post-cryoablation

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

2016

Completed Phase 2

~1040

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,868 Total Patients Enrolled

202 Trials studying Breast Cancer

81,073 Patients Enrolled for Breast Cancer

Yolanda Bryce, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

500 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of individuals participating in this clinical study?

"Indeed, the information available on clinicaltrials.gov highlights that this medical research is actively seeking suitable participants. The trial was initially uploaded on 1/29/2024 and last revised on 1/30/2024. It aims to recruit a total of 30 patients from seven distinct locations."

Answered by AI

Does the FDA officially endorse the combination of Pembrolizumab and cryoablation?

"For this Phase 1 trial, the safety of Pembrolizumab + Cryoablation combination is given a rating of 1 by our team at Power due to the scarcity of evidence supporting its safety and efficacy."

Answered by AI

At present, how many locations are hosting this particular clinical trial?

"For this clinical investigation, there are 7 active sites including Memorial Sloan Kettering Monmouth (Limited protocol activities) in Middletown, Memorial Sloan Kettering Bergen (Limited Protocol Activities) in Montvale, and Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ) in Commack. Additionally, the study is carried out at 4 other diverse locations."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"As per information available on clinicaltrials.gov, this study is actively seeking volunteers. The trial was initially listed on January 29th, 2024 and most recently revised on January 30th, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

2024. "A Study of Pembrolizumab and Cryoablation in People With Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06246968.

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