Expanded Access Program With Nivolumab (BMS-936558) in Combination With Ipilimumab (Yervoy®) in Anti-CTLA-4 Treatment-Naïve Subjects With Unresectable or Metastatic Melanoma (CheckMate 218)

Overview

  • Study type

    Interventional
  • Study phase

    IV
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-003364
    • Jacksonville, Florida: 15-003364
    • Rochester, Minnesota: 15-003364
    NCT ID: NCT02186249
    Sponsor Protocol Number: CA209218

About this study

The purpose of this study is to provide treatment with Nivolumab in combination with Ipilimumab and to assess the safety and tolerability of this combination in subjects who are anti-cytotoxic T lymphocyte associated antigen (CTLA)-4 treatment-naive and have unresectable or metastatic melanoma.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Histologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer (AJCC) 2010 staging system, including mucosal melanoma
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
  • Anti-CTLA-4 treatment-naïve patients who may have had other prior systemic treatment for localized or metastatic disease. Note that prior systemic therapy is permitted if it was completed at least 4 weeks prior to first dose, and all related adverse events have either returned to baseline or stabilized
  • Primary mucosal melanoma is allowed
  • Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 2 weeks after treatment is complete and within 28 days prior to first dose of study drug administration. There must also be no requirement for high doses of systemic corticosteroids that could result in immunosuppression (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration
  • Men and women, aged 18 years

Exclusion Criteria:

  • Active (symptomatic) and not treated brain metastases or leptomeningeal metastases
  • Life expectancy < 6 weeks
  • Subjects diagnosed with primary ocular melanoma
  • Subjects with active, known or suspected autoimmune disease
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. Inhaled or topical steroids and adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted in the absence of active autoimmune disease
  • Prior treatment in any Nivolumab or Ipilimumab clinical study (including those who have been randomized to control)
  • Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
  • Known history of testing positive for Human immunodeficiency virus (HIV) or known Acquired immunodeficiency syndrome (AIDS)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Richard Joseph, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Jacksonville, Fla.

Mayo Clinic principal investigator

Richard Joseph, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

Rochester, Minn.

Mayo Clinic principal investigator

Richard Joseph, M.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

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CLS-20149005

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