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Checkpoint Inhibitor
Cryoablation + Ipilimumab + Nivolumab for Melanoma
Phase 2
Recruiting
Led By Meghan J Mooradian, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-1st cryoablation
Awards & highlights
Study Summary
This trial is testing whether a combination of cryoablation, ipilimumab and nivolumab are safe and effective for those with resistant or growing melanoma after PD-1 inhibitor immunotherapy.
Who is the study for?
Adults over 18 with unresectable melanoma that's grown despite prior immunotherapy can join. They must be fit for dual checkpoint inhibition, have a tumor suitable for cryoablation, good organ/marrow function, and no untreated serious medical issues or need for high-dose steroids. Those with treated hepatitis C or controlled HIV are eligible. Pregnant women and those on certain cancer therapies or with symptomatic brain metastases cannot participate.Check my eligibility
What is being tested?
The trial tests if combining two immunotherapies (ipilimumab and nivolumab) with cryoablation is safe/effective in patients whose melanoma has worsened after PD-1 inhibitor therapy. Cryoablation freezes part of the tumor while the drugs help the immune system fight cancer.See study design
What are the potential side effects?
Possible side effects include inflammation in organs due to immune response, fatigue, digestive problems, skin reactions, hormonal gland issues like thyroid dysfunction, liver inflammation, and potential complications from freezing tumors during cryoablation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with melanoma that can't be removed surgically and it got worse after treatment with specific immune therapies.
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I have a tumor that can be measured with scans or physical exams.
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My tumor can be treated with a special freezing technique guided by imaging.
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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I have brain metastases but no symptoms.
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I can take care of myself but might not be able to do active work.
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My kidney function is good.
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My hepatitis B virus load is undetectable with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-1st cryoablation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-1st cryoablation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Clinical Benefit
Secondary outcome measures
Duration of Overall Response
Number of Participants with Adverse Events
Overall Survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Ipilimumab + Nivolumab + CryoablationExperimental Treatment3 Interventions
Study will be conducted in two stages:
Stage 1: Will enroll 15 participants, and if 6 or more have clinical benefit, the study will proceed to Stage 2.
Baseline CT scan.
Cycle 1-4: Pre-determined doses of ipilimumab and nivolumab. Medications administered under direction of treating oncologist.
Day 2 - 14: Core Needle Biopsy followed by cryoablation between Cycle 1 - 2
Surveillance CT scan at weeks 8 - 12, weeks 16 - 24.
Follow up for 6 months to assess safety after cryoablation. Participants followed for duration of response.
Stage 2: Will enroll 22 participants
Baseline CT scan.
Cycle 1-4: Pre-determined doses of ipilimumab and nivolumab. Medications administered under direction of treating oncologist.
Day 2- 14: Core Needle Biopsy followed by cryoablation between Cycle 1 - 2.
Surveillance CT scan at weeks 8 - 12, weeks 16 - 24
Follow up period to assess safety 6 months after cryoablation. Patients followed for duration of response.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Cryoablation
2016
Completed Phase 2
~1040
Ipilimumab
2014
Completed Phase 3
~2620
Find a Location
Who is running the clinical trial?
William M. Wood FoundationUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,933 Previous Clinical Trials
13,198,520 Total Patients Enrolled
22 Trials studying Melanoma
1,062 Patients Enrolled for Melanoma
Meghan J Mooradian, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am an adult with melanoma that can't be removed surgically and it got worse after treatment with specific immune therapies.I have recovered from side effects of previous cancer treatments.I do not have any uncontrolled illnesses.My cancer is getting worse despite being on ipilimumab/nivolumab.I have a tumor that can be measured with scans or physical exams.I am taking more than 10mg of prednisone or a similar medication daily.I am HIV positive, on treatment, and my viral load is undetectable.You are currently taking a medication that is still being tested and not yet approved for regular use.I cannot stop my blood thinners before a freezing treatment if needed.My lesion for cryoablation has not received prior radiation or local treatments.I am medically fit for dual checkpoint inhibition therapy and do not require high doses of steroids.Your white blood cell count is at least 3,000 per microliter.My tumor can be treated with a special freezing technique guided by imaging.My organs and bone marrow are functioning well.I had hepatitis C but am cured, or I'm being treated with no detectable virus.I have brain metastases but no symptoms.I've had radiation therapy, but not where I'm getting cryoablation.I have brain metastasis or leptomeningeal disease that causes symptoms.I can take care of myself but might not be able to do active work.I am not pregnant or breastfeeding.Your platelet count is at least 75,000 per microliter.Your white blood cell count must be at least 1,000 per microliter.You are expected to live for more than 3 months.Your total bilirubin level should be within the normal range set by the hospital.Your liver enzymes (AST and ALT) are within five times the normal limit.My kidney function is good.My hepatitis B virus load is undetectable with treatment.I have brain metastases but don't need immediate brain-specific treatment.I have another cancer, but it won't affect this trial's treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Ipilimumab + Nivolumab + Cryoablation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential harm could be wrought by Ipilimumab, Nivolumab and Cryoablation treatment?
"The safety of Ipilimumab + Nivolumab + Cryoablation was assessed as a 2 due to the absence of efficacy data from Phase 2 clinical trials, though there is evidence confirming its relative security."
Answered by AI
Does this research still have open enrollment for participants?
"According to clinicaltrials.gov, the recruitment phase of this medical trial has ended as of March 9th 2023; however, there are still 835 other studies actively seeking participants."
Answered by AI
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