Study in Patients With Unresectable And Metastatic Melanoma: The Optimize Study



Status:Active, not recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/28/2018
Start Date:July 31, 2015
End Date:September 30, 2021

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A US Multi-Site Observational Study in Patients With Unresectable And Metastatic Melanoma: The OPTIMIzE Study

This study evaluates the different patterns of care for patients who have unresectable or
metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be
observed. The survival rate of these patients will also be observed.

This is a non-interventional, observational study with the primary objective to assess and
describe "real world" patterns of care in the treatment of patients with unresectable or
metastatic melanoma. A sample size of 1,600 prospective patients will provide sufficient
information to explore this primary objective. There will be no forced number of patients
enrolled into a specific treatment cohort. Setting or controlling specific treatment
enrollment cohort counts would invalidate the results of the primary objective of the study.
No primary hypothesis is being tested.

Inclusion Criteria:

Prospective cohort patients:

- Diagnosis date must occur on or after March 24, 2011 (date of ipilimumab approval in
US)

- Diagnosis of stage III (unresectable) or stage IV melanoma (includes mucosal, uveal
acral-lentiginous, leptomeningeal disease)

- Age ≥ 18 years at time of entry into study

- Patients must be actively receiving or scheduled to receive systemic treatment (any
line, eg, first, second, third line [including investigational drugs]).

- For patients initiating new treatment, treatment must be started within 28 days
after signing informed consent.

- For patients currently receiving treatment, patients must enroll within the first
21 days of starting new treatment

Retrospective cohort patients:

- Patients with diagnosis of confirmed unresectable stage III or stage IV melanoma
(including mucosal, uveal, acral-lentiginous, leptomeningeal disease)

- Age ≥ 18 years at time of unresectable or metastatic melanoma diagnosis

- Initiated therapy for unresectable or metastatic melanoma within 4 years prior to
approval of ipilimumab (first immune checkpoint inhibitor therapy approved in US)

- March 25, 2007 - March 24, 2011

- One year of follow-up data is required from date of therapy initiation, if a patient
passed away within the one year of follow-up; such patients are still eligible and the
date of death will be collected.

1. If retrospective patients have at least one year of follow-up data and are then
treated with immuno-oncology, immune checkpoint inhibitor therapy, or targeted
therapy, these patients will be analyzed separately.

Exclusion Criteria:

Prospective patients:

- Patients participating in a clinical study that does not allow enrollment into a non
interventional study or clinical studies in which the investigational treatment is
blinded

- Patients who started new treatment > 21 days

- Patients who enrolled in study but did not initiate treatment before 28 days

- Patients with current malignancies (except non-melanoma skin cancer and the following
in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma,
or breast) that requires additional systemic therapy
We found this trial at
66
sites
Minneapolis, Minnesota 55455
1510
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Minneapolis, MN
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
2578
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Boston, MA
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2356
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Allentown, PA
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Aurora, Colorado 80045
820
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Austin, Texas 78731
Phone: 512-427-9400
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Baltimore, Maryland 21229
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Bend, OR
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801 Ostrum St
Bethlehem, Pennsylvania 18015
(484) 526-4000
St Luke'S Hospital And Health Network St. Luke's University Health Network (SLUHN) is a nonprofit,...
2361
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Bethlehem, PA
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Bolivar, Missouri 65613
1395
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Bolivar, MO
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Bridgeport, West Virginia 26330
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Bridgeport, WV
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Buffalo, New York 14263
2181
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1455 Harrison Avenue Northwest
Canton, Ohio 44708
Phone: 330-453-9993
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Canton, Ohio 44710
Phone: 330-438-6333
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Canton, OH
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Durham, North Carolina 27705
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Durham, NC
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El Paso, Texas 79902
Phone: 915-544-6750
686
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El Paso, TX
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Erie, Pennsylvania 16505
Phone: 814-838-9000
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Evanston, Illinois 60201
1728
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Evanston, IL
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Everett, Washington 98201
985
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Everett, WA
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8505 Arlington Boulevard
Fairfax, Virginia 22031
2270
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Fairfax, VA
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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...
2430
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Hackensack, NJ
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Harvey, Illinois 60426
1725
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Hattiesburg, Mississippi 39401
Phone: 601-450-5312
1675
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Hattiesburg, MS
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1301 Punchbowl St
Honolulu, Hawaii 96813
(808) 538-9011
Queen's Medical Center The Queen's Medical Center, located in downtown Honolulu, Hawaii, is a private,...
2572
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Honolulu, HI
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Hot Springs, Arkansas 71913
Phone: 501-624-7700
1419
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Huntington, West Virginia 25702
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Jacksonville, Florida 32256
2138
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Jacksonville, FL
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Jacksonville, Florida 32256
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1915 White Ave.
Knoxville, Tennessee 37916
(865) 541-1678
Phone: 865-541-1812
Thompson Cancer Survival Center The Thompson Cancer Survival Center Downtown facility has pioneered many advances...
1923
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Knoxville, TN
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La Crosse, WI
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3525 Lakeland Hills Boulevard
Lakeland, Florida 33805
Phone: 863-904-1900
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Lancaster, Pennsylvania 17601
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Lincoln, Nebraska 68506
Phone: 402-484-4900
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Long Beach, California 90813
Phone: 562-590-0345
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1845
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Longwood, FL
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Martinsburg, West Virginia 25401
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Massillon, Ohio 44646
Phone: 330-478-0001
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Miami Beach, Florida 33140
2324
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Morgantown, West Virginia 26506
(304) 293-0111
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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Morgantown, WV
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Morristown, New Jersey 07960
2435
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Muscle Shoals, Alabama 35661
1725
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Neptune, New Jersey 07753
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New Orleans, Louisiana 70121
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Niles, Illinois 60714
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Omaha, Nebraska 68124
Phone: 402-393-3110
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Orange City, Florida 32763
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225 Medical Center Drive
Paducah, Kentucky 42003
Phone: 270-441-4343
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Paris, Texas 75460
Phone: 903-785-0031
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Pensacola, Florida 32504
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3 Crescent Drive
Philadelphia, Pennsylvania 19107
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PIttsburgh, Pennsylvania 15212
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Pittsburgh, Pennsylvania 15232
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Redondo Beach, California 90277
Phone: 310-750-3300
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Rochester, Minnesota 55905
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Rome, Georgia 30165
1865
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2000 Circle of Hope Dr
Salt Lake City, Utah 84112
(801) 585-0303
Huntsman Cancer Institute at University of Utah Huntsman Cancer Institute (HCI) is part of the...
573
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Savannah, Georgia 31405
Phone: 912-354-6187
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Shreveport, Louisiana 71101
Phone: 318-681-4218
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Skokie, Illinois 60076
Phone: 224-534-7580
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Spokane, Washington 99218
Phone: 509-228-1000
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Springfield, IL
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Tallahassee, Florida 32308
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Tampa, FL
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Topeka, Kansas 66606
Phone: 785-354-5300
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Westwood, Kansas 66205
1338
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2951 Maple Avenue
Zanesville, Ohio 43701
Phone: 740-454-5271
2012
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