HD IL-2 + Vemurafenib in Patients With BRAF Mutation Positive Metastatic Melanoma



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/7/2015
Start Date:August 2012
Contact:Theresa Luna
Email:tluna@prometheuslabs.com
Phone:858-882-8058

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A Multi-Center Study of High Dose Aldesleukin (Interleukin-2) + Vemurafenib Therapy in Patients With BRAFV600 Mutation Positive Metastatic Melanoma

This is a research study to evaluate treatment of metastatic melanoma patients with a
combination of drugs. The combination being studied is vemurafenib (also known as Zelboraf®)
and High Dose Interleukin-2 (abbreviated as HD IL-2 and known as Proleukin®). The
combination of vemurafenib and HD IL-2 immunotherapy may enhance the response.

This will be an open-label, uncontrolled two-arm, multi-center study in patients with
metastatic melanoma with BRAFV600 oncogene mutations. Patients will initially receive
treatment with vemurafenib interspersed with two courses of High Dose IL-2 (HD IL-2).
Patients are eligible for the study if they have melanoma positive for the BRAFV600
mutation, have been on vemurafenib therapy for 0-18 weeks, have responding or stable disease
if on vemurafenib, and meet the requirements for dosing with HD IL-2 and all protocol
inclusion and exclusion criteria.

Two Cohorts will be enrolled, differing only in how they are characterized prior to HD IL-2
treatment:

Cohort 1: will consist of 135 patients naïve to vemurafenib and HD IL-2 therapy. Patients
in Cohort 1 will have an initial evaluation and receive a defined 6 (± 1) week course of
vemurafenib before beginning HD IL-2. This Cohort will be used to define study size and
statistical validity with the comparator being historic controls (using data from the BRAF
positive patients from the Melanoma SELECT study Protocol IIT10PLK06).

Cohort 2: will consist of up to 50 patients who have been on vemurafenib therapy for >7 to
18 weeks with stable or responding disease before starting HD IL-2. Patients in Cohort 2
will have an initial evaluation and will begin HD IL-2 treatment after >7 to 18 weeks of
treatment with vemurafenib. This Cohort is designed to evaluate whether additive or
synergistic clinical benefit or toxicity is observed in BRAFV600 mutation positive
metastatic melanoma patients treated with vemurafenib as a single agent for >7 to18 weeks
prior to the first course of HD IL-2 therapy in conjunction with continued vemurafenib.

Patients in both cohorts will discontinue dosing vemurafenib prior to each treatment with HD
IL-2 and resume dosing after each discharge. Patients will receive up to two courses (four
cycles) of HD IL-2 and will be evaluated for their disease responses at 10 weeks (±3 weeks)
from the start of HD IL-2 dosing, and 26 weeks (±3 weeks) from the start of HD IL-2 dosing.
QTc intervals will be reviewed daily for changes during each cycle of HD IL-2 dosing.

Administration of vemurafenib and HD IL-2 will be according to the respective Package
Inserts and according to the Institution's standard of care. The investigator will
determine the number of HD IL-2 cycles each patient will receive, according to the
investigator's discretion and medical judgment.

Inclusion Criteria:

- Male or female patients 18 years of age or older.

- Confirmed and measurable metastatic melanoma with the BRAFV600 mutation.

- Patients with at least one metastatic melanoma lesion accessible. for biopsy prior to
vemurafenib treatment if no archived tissue is available.

- Meet the requirements for HD IL-2 therapy per institutional guidelines.

- Meet the requirements for vemurafenib therapy per institutional guidelines.

- Patient must be willing to provide written Informed Consent and participate in study
procedures as described in the 12PLK01. Patients consented for 12PLK01 will also be
asked to participate in the 10PLK13 PROCLAIM (Proleukin®) registry study.

Exclusion Criteria:

- A patient will not be considered eligible for study participation if any of the
following exclusion criteria are met:

- Prior therapy of metastatic disease with any of the following: IL-2, Ipilimumab, or
other highly selective BRAF, MEK, NRAS, cMET inhibitors (e.g. GSK2118436 or
GSK1120212) and TKIs.

- Exception: with a 6 week washout the following are allowed:

- Adjuvant Ipilimumab,

- Anti PD-1, Anti PD L-1

- Exclusion for Cohort 1 only: vemurafenib treatment >7 weeks.

- Exclusion for Cohort 2 only: vemurafenib treatment <7 weeks. (eligible for Cohort 1)
or >18 weeks.

- QTc interval of >500ms.

- 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 assessment
at least 6 weeks after definitive therapy are acceptable.)

- Received investigational drug within 30 days prior to study dosing. Patients may
participate in non-interventional or observational clinical study (ies)

- 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
21
sites
Cincinnati, Ohio 45219
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Atlanta, GA
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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Baton Rouge, Louisiana 70809
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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11100 Euclid Avenue
Cleveland, Ohio 44106
216.844.8797
Case Comprehensive Cancer Center The Case Comprehensive Cancer Center (Case CCC) based at Case Western...
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Cleveland, OH
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Easton, Pennsylvania 18045
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Easton, PA
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92 2nd St
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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La Jolla, CA
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Maywood, IL
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Miami Beach, Florida 33140
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Minneapolis, Minnesota 55455
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Park Ridge, Illinois 60068
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5150 Centre Ave
Pittsburgh, Pennsylvania 15232
(412) 647-2811
University of Pittsburgh Cancer Institute Founded in 1985, the University of Pittsburgh Cancer Institute (UPCI)...
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Portland, Oregon 97213
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Tucson, Arizona 85724
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