Cryoablation, Ipilimumab, and Nivolumab for Metastatic Melanoma
This study is looking at whether combining cryoablation (freezing a tumor), ipilimumab, and nivolumab is safe and effective for people with metastatic melanoma (skin cancer that has spread). You might be able to join if your melanoma has grown or resisted previous immunotherapy with a PD-1 inhibitor, and your doctor plans to start you on ipilimumab and nivolumab. The study aims to see how many participants experience a clinical benefit (improvement) at 6 months after the first cryoablation. The current status of this study is unclear, and it plans to enroll about 37 people.
- Study design
- This is a single-arm, two-stage, Phase II study, meaning all participants receive the same treatment combination. Approximately 37 people are expected to take part.
- What's involved
- You would have in-clinic visits, blood draws, CT scans, and tumor biopsies. Your participation is expected to last up to 3 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures clinical benefit at 6 months after the first cryoablation.
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NCT05779423
Cryoablation+Ipilimumab+Nivolumab in Melanoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentMassachusetts General HospitalInvestigator-initiated
~37 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:IpilimumabNivolumabCryoablation
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Clinical Benefit
Measured over 6 months post-1st cryoablation
Conditions
Where it's being run
1 sites across 1 statesMassachusetts1
Study leadership
- Meghan J Mooradian, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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:
Leukocytes ≥3,000/mcL
Absolute neutrophil count ≥1,000/mcL
Platelets ≥75,000/mcL
Total bilirubin ≤3 institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) ≤5 × institutional ULN
CrCL \> 30 ml/min
Known Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. (HIV testing not required at screening).
For participants with known evidence of known chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. (HBV testing not required at screening).
Participants with a history of known hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. (HCV testing not required at screening).
Participants with asymptomatic brain metastases are eligible.
Participants with new or progressive asymptomatic brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion
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.
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.
What this trial measures
- Rate of Clinical Benefit6 months post-1st cryoablation
Defined as the proportion of participants with best overall response per RECIST v1.1 of confirmed complete or partial response or stable disease.