Actively Recruiting
Cryoablation+Ipilimumab+Nivolumab in Melanoma
Led by Massachusetts General Hospital · Updated on 2026-01-06
37
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Cryoablation+Ipilimumab+Nivolumab in Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients over 18 years old with unresectable melanoma progressing after immune checkpoint inhibitor therapy
- Planned treatment with both ipilimumab and nivolumab by treating physician
- Medically eligible for dual checkpoint inhibition with no uncontrolled medical issues or need for high-dose steroids
- Tumor suitable for image-guided percutaneous cryoablation
- Measurable disease present according to RECIST criteria
- Prior radiation allowed except on planned cryoablation site
- ECOG performance status of 0 to 2
- Life expectancy greater than 3 months
- Adequate organ and marrow function as defined by specific blood counts and kidney/liver function
- HIV-positive patients on effective treatment with undetectable viral load allowed
- Patients with controlled hepatitis B or cured hepatitis C allowed
- Patients with asymptomatic or stable brain metastases allowed
- Prior or concurrent malignancy allowed if not interfering with study
- Ability and willingness to provide informed consent
You will not qualify if you...
- Planned cryoablation lesion previously treated with radiation or other local therapy
- Inability to stop anticoagulation if required for cryoablation
- Currently receiving other investigational agents
- Progressing on ipilimumab and nivolumab as last therapy
- Unresolved side effects from prior cancer treatment greater than grade 1
- Symptomatic brain metastases or leptomeningeal disease
- Use of oral prednisone over 10 mg daily or equivalent
- Uncontrolled illness
- Pregnancy or breastfeeding due to potential risks from immune checkpoint inhibitors
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
M
Meghan J Mooradian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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