Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy) in Patients With Metastatic Melanoma
- 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 previously received only one non-immunologic systemic 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.
- 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.)
- Primary ocular or mucosal melanoma
- 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.