HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma
Condition: Metastatic Melanoma
MeSH terms: Melanoma
Intervention: High Dose Interleukin-2; Ipilimumab
Intervention MeSH terms: Aldesleukin; Ipilimumab; Interleukin-2
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: assess the sequenced use of HD IL2 and IPI in metastatic melanoma patients
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: melanoma; metastatic; skin cancer; Stage IV; interleukin-2

Summary:

      Phase IV, open-label, randomized, two-arm, multi-center study in patients with metastatic
      melanoma who are treatment naïve or have previously received a single non-immunologic
      therapy.

      Treatment Arm 1: "HD IL-2 first, then ipilimumab" Patients will receive two courses (four
      cycles) of High Dose Interleukin-2 (HD IL-2) followed by one course (four doses) of
      ipilimumab.

      Treatment Arm 2: Ipilimumab first then HD IL-2 Patients will receive one course (four doses)
      of ipilimumab followed by two courses (four cycles) of HD IL-2.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients 18 years or older

          -  Confirmed and measurable metastatic melanoma with at least one measurable lesion for
             evaluation of response

          -  Meets the requirements for HD IL-2 therapy per Institutional guidelines

          -  Meets the requirements for ipilimumab therapy per Institutional guidelines

          -  Treatment naïve or has received only one systemic therapy apart from adjuvant therapy.

          -  At least 4 weeks since last adjuvant therapy or other cancer treatment

          -  Willing and able to give informed consent and participate in study procedures as
             described in the 12PLK02 and 10PLK13 protocols. Patients consented for 12PLK02 will
             also be asked to participate in the 10PLK13 PROCLAIM registry study.

        Exclusion Criteria:

          -  Patients with known or suspected infection with human immunodeficiency virus (HIV),
             hepatitis C virus (HCV), hepatitis B virus (HBV) or other infectious hepatitis

          -  Pregnant, nursing or planning to become pregnant

          -  Untreated brain metastases. (Brain metastases that have been treated, which no longer
             require corticosteroid therapy and are without progression by MRI at least 6 weeks
             after definitive therapy are acceptable.)

          -  Received prior ipilimumab therapy (Prior Adjuvant Ipilimumab and Adjuvant Interferon
             are permitted with a minimum 4 week washout)

          -  Received prior HD IL-2 therapy.

          -  Received investigational drug within 30 days prior to study dosing. Patients may
             participate in non-interventional or observational clinical studies, including the
             10PLK13 PROCLAIM registry study.

          -  Concomitant disease or condition that would interfere with the conduct of the study or
             that would, in the opinion of the Investigator, pose an unacceptable risk to the
             patient in this study.