Phase II Study of Tocilizumab with Ipilimumab and Nivolumab for Advanced Melanoma
Sponsor: NYU Langone Health
ClinicalTrials ID:NCT03999749
This clinical trial is testing a combination of three drugs—tocilizumab, ipilimumab, and nivolumab—to see if they are safe and effective for patients with advanced melanoma that cannot be surgically removed.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring a new treatment for advanced melanoma using a combination of three drugs: tocilizumab, ipilimumab, and nivolumab. The trial aims to assess the safety and effectiveness of this combination in patients whose melanoma cannot be surgically removed. The treatment is divided into two phases: an initial phase where all three drugs are given together, followed by a maintenance phase with nivolumab alone. The study will help determine if this combination should be tested further in larger trials.
Eligibility Criteria
Inclusion Criteria
- Must sign a consent form agreeing to participate in the study.
- Willing to attend scheduled visits and follow the treatment plan.
- Have advanced melanoma (Stage IIIb/c/d or Stage IV) that cannot be surgically removed.
- All types of melanoma except eye melanoma are allowed.
- Must not have received prior treatment for metastatic melanoma, except for certain surgeries or radiation.
- Must have a complete physical exam and imaging tests before starting the study.
- Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
- Must provide a tumor sample for analysis.
- Any previous brain metastases must be stable and not require steroids.
- Must have normal lab results.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception during and after treatment.
- Men must agree to use contraception during and after treatment.
- Re-enrollment is allowed if previously screened but not treated.
Exclusion Criteria
- Have a history of eye melanoma or cancer in the brain lining.
- Have had another type of cancer unless treated and in remission for at least 2 years.
- Have active autoimmune diseases, except for certain conditions like type I diabetes or skin disorders that don't need treatment.
- Require treatment with high-dose steroids or other immunosuppressive drugs.
- Have had previous treatments for melanoma, except for certain surgeries or radiation.
- Have abnormal lab results or heart conditions that affect the QT interval.
- Have serious heart conditions or uncontrolled medical issues.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| The Angeles Clinic | 90025 | Los Angeles | California |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Dana Farber Cancer Institute | 02215 | Boston | Massachusetts |
| NYU Langone Health | 10016 | New York | New York |
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