Clinical trial NCT02780089: Study in Patients With Unresectable And Metastatic Melanoma: The Optimize Study
Official title: A US Multi-Site Observational Study in Patients With Unresectable And Metastatic Melanoma: The OPTIMIzE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Keywords: Metastatic
Unresectable
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-05-23
Enrollment: 408
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with histologically-confirmed unresectable stage III or stage IV melanoma, (including mucosal, uveal, acral-lentiginous, leptomeningeal disease). Patients can be treatment-naïve or previously treated for unresectable or metastatic melanoma.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patterns of Care
timeFrame: Up to 5 years
measure: Demographics
timeFrame: Up to 5 years
measure: Overall Survival
timeFrame: Up to 5 years
measure: Disease Characteristics
timeFrame: Up to 5 years
Secondary outcomes:
measure: Healthcare Resource
timeFrame: up to 5 years
measure: Functional Assessments of Cancer Therapy-Melanoma (FACT-M)
timeFrame: Up to 12 months
measure: European Quality of Life-5 Dimensions (EQ-5D)
timeFrame: Up to 12 months
measure: Work Productivity and Activity Impairment: General Health (WPAI:GH)
timeFrame: Up to 12 months
measure: The Caregiver Quality of Life Index - Cancer (CQOLC)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Long Beach
country: United States
facility: Pacific Shores Medical Group
state: California
city: Redondo Beach
country: United States
facility: Cancer Care Associates
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Jacksonville
country: United States
facility: 21st Century Oncology
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialits, LLC D/B/A
state: Florida
city: Lakeland
country: United States
facility: Lakeland Regional Health
state: Florida
city: Lakeland
country: United States
facility: Watson Clinical Center for Research, INC
state: Florida
city: Longwood
country: United States
facility: UF Health Cancer Center at Orlando Health
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orange City
country: United States
facility: Mid Florida Hematology and Oncology Centers
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Medical Oncology Group
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Healthcare
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center Moffitt Cancer Center
state: Florida
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Savannah
country: United States
facility: Summit Cancer Care
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Evanston
country: United States
facility: North Shore University Health System
state: Illinois
city: Harvey
country: United States
facility: Ingalls Cancer Research Center
state: Illinois
city: Niles
country: United States
facility: Oncology Specialits, S.C.
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc.
state: Illinois
city: Springfield
country: United States
facility: Simmons Cancer Institute at SIU School of Medicine
state: Illinois
city: Topeka
country: United States
facility: Stormont-Vail Cancer Center
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Paducah
country: United States
facility: West Ky Hematology & Oncology
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: CHRISTUS Schumpert Cancer Treatment Center
state: Louisiana
city: Baltimore
country: United States
facility: Saint Agnes Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Masonic Cancer Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center (MCCC)
state: Minnesota
city: Hattiesburg
country: United States
facility: Forrest General Cancer Center
state: Mississippi
city: Bolivar
country: United States
facility: Central Care Cancer Center
state: Missouri
city: Lincoln
country: United States
facility: Nebraska Hematology-Oncology, P.C.
state: Nebraska
city: Omaha
country: United States
facility: Oncology Hematology West P.C.
state: Nebraska
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Morristown
country: United States
facility: Atlantic Health, Morristown Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Meridian Health
state: New Jersey
city: Buffalo
country: United States
facility: Rosewell Park Cancer Institute
state: New York
city: Durham
country: United States
facility: Center of Learning Healthcare
state: North Carolina
city: Canton
country: United States
facility: Hematolgoy and Oncology Associates, Inc.
state: Ohio
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Massillon
country: United States
facility: Tri-County Hematology and Oncology Associates, Inc
state: Ohio
city: Zanesville
country: United States
facility: Genesis Cancer Care Center
state: Ohio
city: Bend
country: United States
facility: St. Charles Medical Center - Cancer Center
state: Oregon
city: Allentown
country: United States
facility: Network Office of Research & Innovation / Lehigh Valley Health Network
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's Hospital and Health Network
state: Pennsylvania
city: Erie
country: United States
facility: The Regional Cancer Center
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Medical Oncology
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPCI - UPMC Cancer Center
state: Pennsylvania
city: Knoxville
country: United States
facility: Thompson Cancer Survival Center
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology
state: Texas
city: El Paso
country: United States
facility: Texas Oncology
state: Texas
city: Paris
country: United States
facility: Texas Oncology
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
city: Fairfax
country: United States
facility: Inova Melanoma and Skin Cancer Center
state: Virginia
city: Everett
country: United States
facility: Providence Regional Medical Center Everett
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Bridgeport
country: United States
facility: West Virginia University
state: West Virginia
city: Huntington
country: United States
facility: West Virginia University
state: West Virginia
city: Martinsburg
country: United States
facility: West Virginia University Hematolgoy & Oncology
state: West Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: La Crosse
country: United States
facility: Gundersen Lutheran Medical Foundations, Inc.
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: