HD IL-2 + Ipilimumab in Patients With Metastatic Melanoma

Status:	Terminated
Conditions:	Skin Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	May 2013
End Date:	July 2015

Open-Label, Randomized, Multi-Center Study Comparing the Sequence of High Dose Aldesleukin (Interleukin-2) and Ipilimumab (Yervoy) in Patients With Metastatic Melanoma

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: 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: Patients will receive one course (four doses) of ipilimumab followed by two
courses (four cycles) of HD IL-2.

HD IL-2 and ipilimumab dosing regimens will comply with the instructions in the most current
package inserts, institutional guidelines, and medical expertise of the treating physician.
However, neither the ipilimumab nor the HD IL-2 should be dose reduced. If necessary, doses
should be either held or permanently discontinued (per package insert instructions).
Protocol specific dosing guidance is included in the 12PLK02 Work Instructions.

Patients will be scheduled for four response assessments. Response assessment timing should
be targeted to fall within the following time points: between 5-11 weeks, 13-19 weeks, 24-30
weeks and one year after initiating therapy in either treatment arm. Timing of the response
assessments may be adjusted to facilitate clinical procedures and treatment decisions.

Patient treatment tolerability and safety events will be monitored and managed while
enrolled in the 12PLK02 study. Patients who receive HD IL-2 in the 12PLK02 study will be
enrolled in the PROCLAIM study (Registry Protocol 10PLK13) for the collection of long-term
assessment data, including response and disease status and treatment decisions. Patient
treatment data will be entered in to the PROCLAIM database, for a minimum target of 2 years
and potentially up to 5 years, after the patient completes the 12PLK02 study.

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.

We found this trial at

sites

M.D. Anderson Cancer Center

Houston, Texas 77030

from

Houston, TX