Study of Nivolumab (BMS-936558) Plus Ipilimumab Compared With Ipilimumab Alone in the Treatment of Previously Untreated, Unresectable, or Metastatic Melanoma
Condition: Unresectable Melanoma; Metastatic Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Ipilimumab; Placebo
Intervention description: Matching nivolumab
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to compare the objective response rate, as determined by
      investigators, of Nivolumab combined with Ipilimumab versus Ipilimumab monotherapy in
      patients with untreated, unresectable, or metastatic melanoma
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Key Inclusion Criteria:

          -  Eastern Cooperative Oncology Group performance status of 0 or 1

          -  Histologically confirmed unresectable Stage III or Stage IV melanoma

          -  No prior systemic anticancer therapy for unresectable or metastatic melanoma. Note
             that prior adjuvant or neoadjuvant melanoma therapy is permitted if it was completed
             at least 6 weeks prior to date of first dose, and all related adverse events have
             either returned to baseline or stabilized

          -  Tumor tissue obtained in the metastatic setting or from an unresectable site must be
             provided for biomarker analyses and sent to the central laboratory. Biopsy should be
             excisional, incisional punch, or core needle. Fine needle aspirates or other cytology
             samples are insufficient

          -  Known BRAF V600 mutation status as determined by an FDA-approved test. Patients with
             either V600 wild-type or V600 mutation-positive melanoma are eligible.

        Key Exclusion Criteria:

          -  Active brain metastases or leptomeningeal metastases. Patients with treated brain
             metastases are eligible if there is no evidence of progression on magnetic resonance
             imaging scan for at least 8 weeks after completion of treatment 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

          -  Ocular melanoma

          -  Patients with active, known, or suspected autoimmune disease. Those with vitiligo,
             type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only
             requiring hormone replacement, psoriasis not requiring systemic treatment, or
             conditions not expected to recur in the absence of an external trigger are permitted
             to enroll.