Is NCT05779423 recruiting in Boston, MA?

Yes, NCT05779423 is currently recruiting participants at its Boston, MA location. This metastatic melanoma clinical trial is actively enrolling qualified participants.

How do I join the metastatic melanoma clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Melanoma Clinical Trial in Boston, MA

About This Metastatic Melanoma Study in Boston

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

Who Can Participate

Inclusion 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 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 Criteria

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT05779423) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Melanoma Treatment Options in Boston, MA

If you're searching for metastatic melanoma treatment options in Boston, MA, this clinical trial (NCT05779423) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic melanoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic melanoma clinical trials near you to find additional studies recruiting in your area.

Metastatic Melanoma Clinical Trial in Boston, MA

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