Study of Core Needle Biopsy and Cryoablation of an Enlarging Tumor in Patients With Metastatic Lung Cancer and Metastatic Melanoma Receiving Post-progression Immune Checkpoint Inhibitor Therapy

Study summary

This research study is studying cryoablation (a treatment to kill cancer cells with extreme cold) combined with continued treatment with current immune checkpoint inhibitor as a possible treatment for lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCryoablation and Biopsy

The study team can explain what participation involves.

Who it may be forMetastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 18, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Massachusetts General Hospital

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Not applicable
Sponsor: Massachusetts General Hospital
Interventions being studied: Procedure: Cryoablation; Procedure: Biopsy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Adult patients (age \> 18) with stage IV lung cancer receiving commercial supply immune checkpoint inhibitor therapy with progression of disease, and for whom an additional 4-6 weeks of current therapy (post-progression therapy) is acceptable as standard therapy
Must have a growing tumor amenable to percutaneous image-guided cryoablation based on routine Interventional Radiology criteria
Must have measurable disease (by RECIST) independent of the lesion to be ablated. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease.

Reasons someone may not be able to joinExclusion criteria

Participants who are receiving an investigational agent(s)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because immune checkpoint inhibitors have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with immune checkpoint inhibitors, breastfeeding should be discontinued.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Massachusetts General HospitalBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 18, 2024. Always confirm current availability with the study team.

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