RecruitingPhase 2NCT05779423

Cryoablation+Ipilimumab+Nivolumab in Melanoma

A Phase II Study of Core Needle Biopsy and Cryoablation of an Enlarging Tumor in Patients With Advanced Melanoma Receiving Post-progression Dual Immune Checkpoint Inhibitor Therapy


Sponsor

Massachusetts General Hospital

Enrollment

37 participants

Start Date

Sep 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The aim of this study is to find out whether the combination of two approved drugs, ipilimumab and nivolumab, in combination with cryoablation are safe and effective for participants who have an unresectable melanoma that is resistant, or is growing, after receiving immunotherapy with a PD-1 inhibitor. The names of the study interventions involved in this study are: * Cryoablation (an interventional radiology procedure that freezes part of a tumor) * Ipilimumab (an immunotherapy) * Nivolumab (an immunotherapy)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination approach for melanoma (skin cancer) that has stopped responding to immunotherapy. It combines cryoablation (freezing tumors to destroy them) with a dual immunotherapy regimen using ipilimumab and nivolumab. The idea is that destroying a tumor with cold may release signals that help the immune system attack remaining cancer cells. **You may be eligible if:** - You are over 18 and have unresectable (inoperable) melanoma - Your cancer has progressed after treatment with immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab, ipilimumab) - Your doctor plans to start you on dual immunotherapy with ipilimumab and nivolumab - You are healthy enough to tolerate dual immunotherapy **You may NOT be eligible if:** - You are not medically eligible for dual immunotherapy - You have conditions that would make cryoablation unsafe 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

DRUGIpilimumab

Monoclonal antibody administered through intravenous infusion

DRUGNivolumab

Monoclonal antibody administered through intravenous infusion

PROCEDURECryoablation

Procedure of freezing a tumor performed via CT-guidance by interventional radiologist.


Locations(1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

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NCT05779423


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