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A Phase II 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
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.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The FDA (the U.S. Food and Drug Administration) has approved each aspect of this therapy, however this research study is unique because it combines them as a treatment option for the participant's disease. That has not been approved by the FDA. In this research study, The investigators are... * Continuing the participant on the participant's immune checkpoint inhibitor therapy even though the participant's doctor believes that the participant's cancer is growing. Since the participant's cancer is growing, there is only a small chance the participant will respond to continued drug therapy. * Taking a biopsy of the participant's cancer to confirm there is cancer growing in the location to be treated. * Performing cryoablation on an enlarging tumor. This involves passing a special needle into the participant's body (cryoprobe) to freeze tumor and kill a small part (not all) of the participant's cancer. Your immune system will respond to the damage caused by freezing part of the participant's tumor. * The investigators are hoping to demonstrate that combining post-progression immune checkpoint inhibitor therapy with cryoablation is safe, and may induce and/or restore an immune response to cancer in other places in the participant's body
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
January 17, 2018
Primary Completion Date
September 30, 2023
Completion Date
November 30, 2023
Last Updated
March 18, 2024
30
ACTUAL participants
Cryoablation
PROCEDURE
Biopsy
PROCEDURE
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT07336732
NCT06066138
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06498635