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
Massachusetts General Hospital
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)
Description
This is a single-arm, two-stage, Phase II clinical trial to test the safety and effectiveness of an investigational treatment, the combination of ipilimumab and nivolumab with cryoablation, for the treatment of metastatic melanoma resistant to PD-1 inhibition. Ipilimumab and nivolumab are types of inhibitors. Ipilimumab targets and blocks specific proteins in cancer cells which are responsible for stopping the immune system from working correctly. Nivolumab targets a receptor on cancer cells that causes programmed cell death. The U.S. Food and Drug Administration has approved Ipilimumab and…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Adult patients (age \> 18) with unresectable melanoma who have progressed on immune checkpoint inhibitor therapy (pembrolizumab, nivolumab, nivolumab-relatimab, atezolizumab, ipilimumab) and for whom their treating physician plans to initiate dual ICI with ipilimumab and nivolumab. Progression on adjuvant PD-1 inhibition is permitted. PD-1 does not have to be the last therapy received. This is no limited on prior lines of ICI received. There is no wash-out period required from the time of their last therapy. * Patients are medically eligible for dual checkpoint inhibitio…
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.
Location
- Massachusetts General Hospital Cancer CenterBoston, Massachusetts