Cryoablation+Ipilimumab+Nivolumab in Melanoma
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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)
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ 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 inhibition (i.e. no untreated/uncontrolled intercurrent medical issue including ongoing immune-related adverse event or need for systemic steroids \>10mg PO prednisone or its equivalent, ECOG PS ≤2) with ipilimumab 3mg/kg and nivolumab 1mg/kg by their treating physician
- ✓ Must have a tumor amenable to percutaneous image-guided cryoablation based on routine Interventional Radiology criteria.
- ✓ Patients 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 (Measurement of Effect) for evaluation of measurable disease.
- ✓ Prior radiation therapy to any site is allowed; with an exception of the target site for planned cryoablation
- ✓ ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- ✓ Life expectancy of greater than 3 months
- ✓ Participants must have adequate organ and marrow function as defined below:
You may not qualify if…
- ✕ Lesion to undergo cryoablation cannot have had prior radiation therapy or other locoregional therapy
- ✕ Inability to hold systemic anticoagulation prior to cryoablation (if holding anticoagulation is required by the operator)
- ✕ Participants who are receiving an investigational agent(s).
- ✕ Participants who are progressing on combination ipilimumab/nivolumab as their last line of therapy
- ✕ Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1)
- ✕ Patients with symptomatic brain metastasis or LMD
- ✕ Participants on \> 10mg of oral prednisone or its equivalent
- ✕ Participants with uncontrolled intercurrent illness.
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT05779423 · last updated 2026-05-19