Phase II Study of Tocilizumab with Ipilimumab and Nivolumab for Advanced Melanoma

Sponsor: NYU Langone Health

Sponsor score: 40

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

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

FACILITYZIPCITYSTATE
The Angeles Clinic90025Los AngelesCalifornia
Massachusetts General Hospital02114BostonMassachusetts
Dana Farber Cancer Institute02215BostonMassachusetts
NYU Langone Health10016New YorkNew York

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