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New treatment option for Metastatic Melanoma
Official title Cryoablation+Ipilimumab+Nivolumab in Melanoma
ClinicalTrials.gov ID: NCT05779423
What this study is testing
What is Ipilimumab?
Ipilimumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic melanoma.
Also referred to as Yervoy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients (age \> 18) with unresectable melanoma who have progressed on immune checkpoint inhibitor therapy (pembrolizumab, nivolumab...
- Patients are medically eligible for dual checkpoint inhibition (i.e. no untreated/uncontrolled intercurrent medical issue including ongoing...
- Must have a tumor amenable to percutaneous image-guided cryoablation based on routine treatment 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...
- Prior radiation therapy to any site is allowed; with an exception of the target site for planned cryoablation
You likely can't join 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
See the full eligibility 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...
- 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...
- Must have a tumor amenable to percutaneous image-guided cryoablation based on routine treatment 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...
- 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...
- 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...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.